Cachexia
Conditions
Keywords
Cachexia, COPD, Chronic Obstructive Pulmonary Disease
Brief summary
To evaluate SUN11031 for subcutaneous injection compared to placebo in subjects with cachexia associated with Chronic Obstructive Pulmonary Disease (COPD) to determine the effect on physical performance and body composition.
Interventions
DRUGPlacebo comparator
Twice daily subcutaneous injections of placebo for 12 weeks.
DRUGSUN11031 20 μg/kg
Twice daily subcutaneous injections of SUN11031 20 μg/kg for 12 weeks.
DRUGSUN11031 40 μg/kg
Twice daily subcutaneous injections of SUN11031 40 μg/kg for 12 weeks.
Sponsors
Daiichi Sankyo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Each participant had to meet the following criteria to be enrolled in the study: 1. Male or non-pregnant female participants 50 years or older with a clinical diagnosis of Chronic Obstructive Pulmonary Disease (COPD) for greater than or equal to 12 months 2. Walked a distance of greater than or equal to 100 but less than or equal to 450 meters during the 6-Minute Walk Test (MWT) performed at screening. 3. Chest x-ray within the past year that was compatible with COPD 4. Documented involuntary nonedematous weight loss of greater than 5% of participant's usual body weight over the past 12 months or BMI less than or equal to 21 kg/m\^2 for males or Body Mass Index (BMI) less than or equal to 20 kg/m\^2 for females 5. Female participants who were clinically sterile (eg, either postmenopausal or had undergone a tubal ligation or hysterectomy) or were practicing a medically acceptable method of birth control (eg, oral, transdermal, implantable, or injectable contraceptive medications; double-barrier method or intrauterine device)
Exclusion criteria
Participants who met any of the following criteria were excluded from the study: 1. BMI greater than 26 kg/m\^2 2. Used, over a total of 7 or more days, parenteral corticosteroids at a dose equivalent to prednisone at greater than or equal to 5 mg/day or oral corticosteroids at a dose equivalent to prednisone at greater than 10 mg/day within the 2 months before screening; however, participants were allowed to participate if on stable doses equivalent to prednisone at less than or equal to 10 mg/day for at least 2 months before screening, and were planning to remain on the same stable dose throughout the study 3. Were planning to start a pulmonary rehabilitation program during the study (participant may have been enrolled in the study if he or she was currently on a stable maintenance program) 4. Weight loss that was considered to be, in the opinion of the investigator, the result of food deprivation 5. Unintended weight loss that may have been due to disease other than COPD 6. Unable or unwilling to be trained to self-administer the study drug by subcutaneous injection bid, and for whom arrangements could not be made for a third party to reliably administer the injections 7. Severe anemia (hemoglobin less than or equal to 8 g/dL) 8. COPD exacerbation defined as a Type 1 or 2 exacerbation according to the Winnipeg criteria, acute infection, or prolonged fever within 4 weeks before screening 9. Undergoing treatment or evaluation for cancer, or had a history of treatment for cancer within the past 3 years, exception being nonmelanoma skin cancer (basal cell or squamous cell carcinoma of the skin) and carcinoma in situ of the cervix 10. Type I or type II diabetes mellitus or a fasting serum glucose of greater than or equal to 115 mg/dL (6.4 mmol/L) (fasting was overnight) 11. Serious disease or conditions that would have interfered with the participant's ability to complete the functional measures included in this protocol; or any illness that, in the opinion of the investigator, might have interfered with the results of the study or the participant's ability to participate 12. Pulmonary embolism, deep venous thrombosis, or clinically significant primary pulmonary hypertension within the past 6 months 13. Significant ischemic heart disease or chronic heart failure (New York Heart Association Class IV cardiac disease) 14. Uncontrolled hypertension (systolic blood pressure greater than 160 mm Hg or diastolic blood pressure greater than 110 mm Hg) 15. A history of symptomatic orthostatic hypotension or syncope; or orthostatic hypotension at screening or baseline (Days -6 to -3) (orthostatic hypotension was defined as a decrease in systolic blood pressure by greater than or equal to 20 mm Hg measured after 2 minutes in a standing position compared with the systolic blood pressure measured after 10 minutes in a supine position) 16. Evidence of ascites, pleural effusion, or lower extremity edema 17. Severe vitamin D deficiency (25-hydroxyvitamin D less than 10 ng/mL) 18. Known mechanical obstruction of the alimentary tract and/or malabsorption 19. Dental or swallowing problems that may have had a negative effect on food intake 20. Serum creatinine greater than 2.5 mg/dL; or alanine aminotransferase, aspartate aminotransferase, or gamma-glutamyl transferase greater than 3 times the upper limit of normal, or bilirubin greater than 2.5 mg/dL 21. A diagnosis of human immunodeficiency virus infection or AIDS 22. Used any prescription drugs and non-prescription drugs/herbs that cause weight loss or affect appetite and absorption or that may cause nausea; or used appetite-promoting or anabolic medications within 15 days before screening 23. A history of alcohol or drug abuse that, in the opinion of the investigator, would have interfered with the participant's ability to comply with the dosing schedule and protocol-specified requirements 24. Hypersensitive to any component of SUN11031, or participated at any time in any study in which SUN11031 was administered 25. Received an investigational drug or product, or participated in a drug study within 30 days before screening 26. Non-ambulatory or unwilling to cooperate fully with the investigator or a designee, or unwilling or unable to comply with study requirements, such as all assessments required by the protocol, including completion of measures for functional capacity and pulmonary function, or frequent blood sampling and meal instructions; or unable or unwilling to attend all study visits
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline to Day 85 in the Distance Walked During the 6 Minute Walk Test (MWT) Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Baseline up to Day 85 post dose. | Assessment of functional capacity in study participants with chronic obstructive pulmonary disease (COPD) via the 6-minute walk test (6MWT) provided an objective measure of disability. The 6MWT is a practical and objective evaluation of functional exercise capacity. The test measures the distance that a participant can quickly walk on a flat, hard surface in 6 minutes. In order to ensure uniformity among the sites, the specifications of the course for the 6MWT were modified from being 30 meters long with 60-meter laps to be 15 meters long with 30-meter laps to accommodate space limitations encountered at select sites. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Baseline up to Day 29, Day 57, and Day 85 post dose. | Assessment of functional capacity in study participants with chronic obstructive pulmonary disease (COPD) via the 6-minute walk test (6MWT) provided an objective measure of disability. The 6MWT is a practical and objective evaluation of functional exercise capacity. The test measures the distance that a participant can quickly walk on a flat, hard surface in 6 minutes. In order to ensure uniformity among the sites, the specifications of the course for the 6MWT were modified from being 30 meters long with 60-meter laps to be 15 meters long with 30-meter laps to accommodate space limitations encountered at select sites. |
| Number of Participants With Improvement in Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Baseline up to Day 85 post dose. | Assessment of functional capacity in study participants with chronic obstructive pulmonary disease (COPD) via the 6-minute walk test (6MWT) provided an objective measure of disability. The 6MWT is a practical and objective evaluation of functional exercise capacity. The test measures the distance that a participant can quickly walk on a flat, hard surface in 6 minutes. In order to ensure uniformity among the sites, the specifications of the course for the 6MWT were modified from being 30 meters long with 60-meter laps to be 15 meters long with 30-meter laps to accommodate space limitations encountered at select sites. |
| Mean Change in Body Weight From Baseline Through Day 99 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Baseline up to Day 8, Day 15, Day 22, Day 29, Day 43, Day 57, Day 85, and Day 99 post dose. | Measurements of body weight were performed in the morning when the participant had an empty stomach (ie, had consumed no food overnight) and had emptied the bladder and had a bowel movement, if possible. These measurements were performed using the same calibrated scale for an individual participant throughout study. |
| Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Baseline up to Day 29, Day 57, and Day 85 post dose. | Assessment of functional capacity in study participants with chronic obstructive pulmonary disease (COPD) via the 6-minute walk test (6MWT) provided an objective measure of disability. The 6MWT is a practical and objective evaluation of functional exercise capacity. The test measures the distance that a participant can quickly walk on a flat, hard surface in 6 minutes. In order to ensure uniformity among the sites, the specifications of the course for the 6MWT were modified from being 30 meters long with 60-meter laps to be 15 meters long with 30-meter laps to accommodate space limitations encountered at select sites. |
| Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Day 1 and Day 85 pre-dose; Day 1 at 1 hour and 4 hours; Day 29 at 0.08 hours and 1.5 hours; Day 57 at 0.08 hours and 6 hours; Day 85 at 0.5 hours and 3 hours postdose. | Absolute concentrations of SUN11031 in participant plasma samples were measured. When participants were randomly assigned into 1 of 3 treatment groups at baseline, they were also randomly assigned into 1 of 2 sequences in the pharmacokinetic (PK) sparse sampling schedule based on the randomization number. |
| Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Day 1 and Day 85 pre-dose; Day 1 at 1 hour and 4 hours; Day 29 at 0.08 hours and 1.5 hours; Day 57 at 0.08 hours and 6 hours; Day 85 at 0.5 hours and 3 hours postdose. | Absolute concentrations of SUN11031 metabolites desacyl-ghrelin in participant plasma samples were measured. When participants were randomly assigned into 1 of 3 treatment groups at baseline, they were also randomly assigned into 1 of 2 sequences in the pharmacokinetic (PK) sparse sampling schedule based on the randomization number. |
| Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Baseline up to Day 113 post dose, up to a total of 134 days. | Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred from the time treatment was administered at Day 1 through the last follow-up visit or a worsening of a pre-existing condition. |
| Mean Change in Lean Body Mass From Baseline Through Days 29, 85 and 99 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Baseline up to Day 29, Day 85, and Day 99 post dose. | Lean body mass was assessed based on whole-body dual-energy x-ray absorptiometry (DXA). |
Countries
Argentina, Chile, Guatemala, Honduras, Romania, United States
Participant flow
Recruitment details
A total of 227 participants who met all inclusion criteria and no exclusion criteria were enrolled in the study at 11 clinic sites in the United States of America (USA), 19 in Argentina, 3 in Chile, 4 in Guatemala, 2 in Honduras, and 6 in Romania. Three (3) participants were enrolled but not treated with the study drug. The remaining 224 enrolled participants were teated.
Pre-assignment details
Spirometry was performed on participants during screening to define the pulmonary function of each participating subject enrolled in this study.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants with chronic obstructive pulmonary disease who were administered SUN11031-matching placebo subcutaneous injections twice daily for 12 weeks. | 73 |
| SUN11031 20 μg/kg Participants with chronic obstructive pulmonary disease who were administered SUN11031 20 μg/kg subcutaneous injections twice daily for 12 weeks. | 75 |
| SUN11031 40 μg/kg Participants with chronic obstructive pulmonary disease who were administered SUN11031 40 μg/kg subcutaneous injections twice daily for 12 weeks. | 76 |
| Total | 224 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 3 | 4 | 4 |
| Overall Study | Death | 0 | 0 | 1 |
| Overall Study | Exacerbation of COPD | 1 | 3 | 0 |
| Overall Study | Exacerbation of COPD (Not treated) | 1 | 0 | 0 |
| Overall Study | Investigator/Sponsor decision | 1 | 0 | 2 |
| Overall Study | Lost to Follow-up | 1 | 1 | 0 |
| Overall Study | Withdrew consent | 0 | 7 | 4 |
| Overall Study | Withdrew consent (not treated) | 2 | 0 | 0 |
Baseline characteristics
| Characteristic | Placebo | SUN11031 20 μg/kg | SUN11031 40 μg/kg | Total |
|---|---|---|---|---|
| Age, Continuous | 66.0 years STANDARD_DEVIATION 8.85 | 64.5 years STANDARD_DEVIATION 8.03 | 66.2 years STANDARD_DEVIATION 9.2 | 65.6 years STANDARD_DEVIATION 8.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 57 Participants | 63 Participants | 59 Participants | 179 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants | 12 Participants | 17 Participants | 45 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants | 7 Participants | 4 Participants | 19 Participants |
| Race (NIH/OMB) White | 65 Participants | 67 Participants | 71 Participants | 203 Participants |
| Sex: Female, Male Female | 31 Participants | 24 Participants | 24 Participants | 79 Participants |
| Sex: Female, Male Male | 42 Participants | 51 Participants | 52 Participants | 145 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 73 | 0 / 75 | 2 / 76 |
| other Total, other adverse events | 54 / 73 | 54 / 75 | 47 / 76 |
| serious Total, serious adverse events | 6 / 73 | 6 / 75 | 8 / 76 |
Outcome results
Primary
Mean Change From Baseline to Day 85 in the Distance Walked During the 6 Minute Walk Test (MWT) Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD)
Assessment of functional capacity in study participants with chronic obstructive pulmonary disease (COPD) via the 6-minute walk test (6MWT) provided an objective measure of disability. The 6MWT is a practical and objective evaluation of functional exercise capacity. The test measures the distance that a participant can quickly walk on a flat, hard surface in 6 minutes. In order to ensure uniformity among the sites, the specifications of the course for the 6MWT were modified from being 30 meters long with 60-meter laps to be 15 meters long with 30-meter laps to accommodate space limitations encountered at select sites.
Time frame: Baseline up to Day 85 post dose.
Population: Distance walked during the 6 Minute Walk Test was assessed using the Intent-to-Treat population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline to Day 85 in the Distance Walked During the 6 Minute Walk Test (MWT) Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Baseline | 317.30 meters | Standard Deviation 80.62 |
| Placebo | Mean Change From Baseline to Day 85 in the Distance Walked During the 6 Minute Walk Test (MWT) Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Change at Day 85 | 28.50 meters | Standard Deviation 54.72 |
| SUN11031 20 μg/kg | Mean Change From Baseline to Day 85 in the Distance Walked During the 6 Minute Walk Test (MWT) Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Baseline | 333.93 meters | Standard Deviation 78.91 |
| SUN11031 20 μg/kg | Mean Change From Baseline to Day 85 in the Distance Walked During the 6 Minute Walk Test (MWT) Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Change at Day 85 | 5.85 meters | Standard Deviation 53.38 |
| SUN11031 40 μg/kg | Mean Change From Baseline to Day 85 in the Distance Walked During the 6 Minute Walk Test (MWT) Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Baseline | 333.30 meters | Standard Deviation 68.2 |
| SUN11031 40 μg/kg | Mean Change From Baseline to Day 85 in the Distance Walked During the 6 Minute Walk Test (MWT) Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Change at Day 85 | 10.04 meters | Standard Deviation 62.16 |
Secondary
Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease
Absolute concentrations of SUN11031 in participant plasma samples were measured. When participants were randomly assigned into 1 of 3 treatment groups at baseline, they were also randomly assigned into 1 of 2 sequences in the pharmacokinetic (PK) sparse sampling schedule based on the randomization number.
Time frame: Day 1 and Day 85 pre-dose; Day 1 at 1 hour and 4 hours; Day 29 at 0.08 hours and 1.5 hours; Day 57 at 0.08 hours and 6 hours; Day 85 at 0.5 hours and 3 hours postdose.
Population: Absolute concentrations of SUN11031 were assessed using the pharmacokinetic population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 2: Postdose 0.08 Hrs, Day 29 and Day 57 | 278.61 pg/mL | Standard Deviation 1278.26 |
| Placebo | Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1: Predose 0 hrs, Day 1 | 49.09 pg/mL | Standard Deviation 41.92 |
| Placebo | Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1+2: Postdose 1.5 Hrs, Day 29 | 27.28 pg/mL | Standard Deviation 24.42 |
| Placebo | Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1+2: Postdose 0.08 Hrs, Day 29 and Day 57 | 155.11 pg/mL | Standard Deviation 883.6 |
| Placebo | Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1: Predose 0 hrs, Day 85 | 55.95 pg/mL | Standard Deviation 68.44 |
| Placebo | Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 2: Postdose 1.5 Hrs, Day 29 | 27.28 pg/mL | Standard Deviation 24.42 |
| Placebo | Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 2: Postdose 0.5 Hrs, Day 85 | 415.01 pg/mL | Standard Deviation 1990.46 |
| Placebo | Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1+2: Postdose 6 Hrs, Day 57 | 51.39 pg/mL | Standard Deviation 71.32 |
| Placebo | Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1+2: Postdose 1 Hr, Day 1 | 483.03 pg/mL | Standard Deviation 2593.24 |
| Placebo | Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1+2: Postdose 0.5 Hrs, Day 85 | 415.01 pg/mL | Standard Deviation 1990.46 |
| Placebo | Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1+2: Postdose 4 Hrs, Day 1 | 52.99 pg/mL | Standard Deviation 64.23 |
| Placebo | Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1: Postdose 1 Hr, Day 1 | 483.03 pg/mL | Standard Deviation 2593.24 |
| Placebo | Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 2: Predose 0 hrs, Day 85 | 49.37 pg/mL | Standard Deviation 52.93 |
| Placebo | Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1: Postdose 6 Hrs, Day 57 | 51.39 pg/mL | Standard Deviation 71.32 |
| Placebo | Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 2: Postdose 4 Hrs, Day 1 | 52.99 pg/mL | Standard Deviation 64.23 |
| Placebo | Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1+2: Predose 0 hrs, Day 85 | 52.72 pg/mL | Standard Deviation 60.88 |
| Placebo | Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1+2: Predose 0 hrs, Day 1 | 54.01 pg/mL | Standard Deviation 72.46 |
| Placebo | Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1+2: Postdose 3 Hrs, Day 85 | 43.80 pg/mL | Standard Deviation 72.69 |
| Placebo | Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1: Postdose 0.08 Hrs, Day 29 and Day 57 | 42.51 pg/mL | Standard Deviation 37.29 |
| Placebo | Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 2: Predose 0 hrs, Day 1 | 58.93 pg/mL | Standard Deviation 94.06 |
| Placebo | Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1: Postdose 3 Hrs, Day 85 | 43.80 pg/mL | Standard Deviation 72.69 |
| SUN11031 20 μg/kg | Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1+2: Postdose 4 Hrs, Day 1 | 1156.16 pg/mL | Standard Deviation 2859.47 |
| SUN11031 20 μg/kg | Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1: Predose 0 hrs, Day 1 | 392.00 pg/mL | Standard Deviation 2032.51 |
| SUN11031 20 μg/kg | Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 2: Predose 0 hrs, Day 1 | 1083.62 pg/mL | Standard Deviation 5600.63 |
| SUN11031 20 μg/kg | Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1+2: Predose 0 hrs, Day 1 | 727.64 pg/mL | Standard Deviation 4147.16 |
| SUN11031 20 μg/kg | Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1: Predose 0 hrs, Day 85 | 46.51 pg/mL | Standard Deviation 26.006 |
| SUN11031 20 μg/kg | Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 2: Predose 0 hrs, Day 85 | 1493.67 pg/mL | Standard Deviation 4939.87 |
| SUN11031 20 μg/kg | Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1+2: Predose 0 hrs, Day 85 | 729.14 pg/mL | Standard Deviation 3434.37 |
| SUN11031 20 μg/kg | Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1: Postdose 0.08 Hrs, Day 29 and Day 57 | 10967.36 pg/mL | Standard Deviation 8543.58 |
| SUN11031 20 μg/kg | Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 2: Postdose 0.08 Hrs, Day 29 and Day 57 | 16094.13 pg/mL | Standard Deviation 12895.48 |
| SUN11031 20 μg/kg | Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1+2: Postdose 0.08 Hrs, Day 29 and Day 57 | 13382.32 pg/mL | Standard Deviation 10834.41 |
| SUN11031 20 μg/kg | Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 2: Postdose 0.5 Hrs, Day 85 | 9508.98 pg/mL | Standard Deviation 6547.42 |
| SUN11031 20 μg/kg | Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1+2: Postdose 0.5 Hrs, Day 85 | 9508.98 pg/mL | Standard Deviation 6547.42 |
| SUN11031 20 μg/kg | Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1: Postdose 1 Hr, Day 1 | 4761.62 pg/mL | Standard Deviation 5209.23 |
| SUN11031 20 μg/kg | Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1+2: Postdose 1 Hr, Day 1 | 4761.62 pg/mL | Standard Deviation 5209.23 |
| SUN11031 20 μg/kg | Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 2: Postdose 1.5 Hrs, Day 29 | 3086.34 pg/mL | Standard Deviation 4433.97 |
| SUN11031 20 μg/kg | Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1+2: Postdose 1.5 Hrs, Day 29 | 3086.34 pg/mL | Standard Deviation 4433.97 |
| SUN11031 20 μg/kg | Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1: Postdose 3 Hrs, Day 85 | 1137.22 pg/mL | Standard Deviation 3218.04 |
| SUN11031 20 μg/kg | Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1+2: Postdose 3 Hrs, Day 85 | 1137.22 pg/mL | Standard Deviation 3218.04 |
| SUN11031 20 μg/kg | Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 2: Postdose 4 Hrs, Day 1 | 1156.16 pg/mL | Standard Deviation 2859.47 |
| SUN11031 20 μg/kg | Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1: Postdose 6 Hrs, Day 57 | 304.67 pg/mL | Standard Deviation 1157.61 |
| SUN11031 20 μg/kg | Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1+2: Postdose 6 Hrs, Day 57 | 304.67 pg/mL | Standard Deviation 1157.61 |
| SUN11031 40 μg/kg | Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 2: Postdose 0.08 Hrs, Day 29 and Day 57 | 23107.50 pg/mL | Standard Deviation 17012.1 |
| SUN11031 40 μg/kg | Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 2: Predose 0 hrs, Day 1 | 79.49 pg/mL | Standard Deviation 105.07 |
| SUN11031 40 μg/kg | Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1+2: Postdose 1.5 Hrs, Day 29 | 6337.84 pg/mL | Standard Deviation 5955.82 |
| SUN11031 40 μg/kg | Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1: Postdose 0.08 Hrs, Day 29 and Day 57 | 22717.98 pg/mL | Standard Deviation 16899.7 |
| SUN11031 40 μg/kg | Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1+2: Postdose 6 Hrs, Day 57 | 431.94 pg/mL | Standard Deviation 1282.37 |
| SUN11031 40 μg/kg | Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1: Postdose 3 Hrs, Day 85 | 2415.05 pg/mL | Standard Deviation 5479.82 |
| SUN11031 40 μg/kg | Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1+2: Predose 0 hrs, Day 85 | 660.36 pg/mL | Standard Deviation 3879.76 |
| SUN11031 40 μg/kg | Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1: Postdose 6 Hrs, Day 57 | 431.94 pg/mL | Standard Deviation 1282.37 |
| SUN11031 40 μg/kg | Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1+2: Postdose 3 Hrs, Day 85 | 2415.05 pg/mL | Standard Deviation 5479.83 |
| SUN11031 40 μg/kg | Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 2: Predose 0 hrs, Day 85 | 258.34 pg/mL | Standard Deviation 1052.19 |
| SUN11031 40 μg/kg | Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1: Predose 0 hrs, Day 1 | 2125.02 pg/mL | Standard Deviation 9355.92 |
| SUN11031 40 μg/kg | Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 2: Postdose 4 Hrs, Day 1 | 473.67 pg/mL | Standard Deviation 1038.69 |
| SUN11031 40 μg/kg | Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1+2: Postdose 0.5 Hrs, Day 85 | 26420.12 pg/mL | Standard Deviation 16539.03 |
| SUN11031 40 μg/kg | Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1: Predose 0 hrs, Day 85 | 1090.10 pg/mL | Standard Deviation 5491.94 |
| SUN11031 40 μg/kg | Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1: Postdose 1 Hr, Day 1 | 14623.63 pg/mL | Standard Deviation 13535.3 |
| SUN11031 40 μg/kg | Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 2: Postdose 0.5 Hrs, Day 85 | 26420.12 pg/mL | Standard Deviation 16539.03 |
| SUN11031 40 μg/kg | Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1+2: Predose 0 hrs, Day 1 | 1014.59 pg/mL | Standard Deviation 6354.99 |
| SUN11031 40 μg/kg | Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1+2: Postdose 1 Hr, Day 1 | 14623.63 pg/mL | Standard Deviation 13535.3 |
| SUN11031 40 μg/kg | Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1+2: Postdose 0.08 Hrs, Day 29 and Day 57 | 22918.34 pg/mL | Standard Deviation 16823.84 |
| SUN11031 40 μg/kg | Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1+2: Postdose 4 Hrs, Day 1 | 473.67 pg/mL | Standard Deviation 1038.69 |
| SUN11031 40 μg/kg | Absolute Concentrations of SUN11031 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 2: Postdose 1.5 Hrs, Day 29 | 6337.84 pg/mL | Standard Deviation 5955.82 |
Secondary
Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease
Absolute concentrations of SUN11031 metabolites desacyl-ghrelin in participant plasma samples were measured. When participants were randomly assigned into 1 of 3 treatment groups at baseline, they were also randomly assigned into 1 of 2 sequences in the pharmacokinetic (PK) sparse sampling schedule based on the randomization number.
Time frame: Day 1 and Day 85 pre-dose; Day 1 at 1 hour and 4 hours; Day 29 at 0.08 hours and 1.5 hours; Day 57 at 0.08 hours and 6 hours; Day 85 at 0.5 hours and 3 hours postdose.
Population: Absolute concentrations of SUN11031 metabolites were assessed using the pharmacokinetic population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 2: Postdose 0.08 Hrs, Day 29 and Day 57 | 292.21 pg/mL | Standard Deviation 655.71 |
| Placebo | Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1: Predose 0 hrs, Day 1 | 189.79 pg/mL | Standard Deviation 170.09 |
| Placebo | Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1+2: Postdose 1.5 Hrs, Day 29 | 105.15 pg/mL | Standard Deviation 77.91 |
| Placebo | Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1+2: Postdose 0.08 Hrs, Day 29 and Day 57 | 233.54 pg/mL | Standard Deviation 481.75 |
| Placebo | Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1: Predose 0 hrs, Day 85 | 207.81 pg/mL | Standard Deviation 227.93 |
| Placebo | Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 2: Postdose 1.5 Hrs, Day 29 | 105.15 pg/mL | Standard Deviation 77.91 |
| Placebo | Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 2: Postdose 0.5 Hrs, Day 85 | 417.51 pg/mL | Standard Deviation 1407.84 |
| Placebo | Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1+2: Postdose 6 Hrs, Day 57 | 149.58 pg/mL | Standard Deviation 166.07 |
| Placebo | Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1+2: Postdose 1 Hr, Day 1 | 438.24 pg/mL | Standard Deviation 1658.63 |
| Placebo | Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1+2: Postdose 0.5 Hrs, Day 85 | 417.51 pg/mL | Standard Deviation 1407.84 |
| Placebo | Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1+2: Postdose 4 Hrs, Day 1 | 132.97 pg/mL | Standard Deviation 126.11 |
| Placebo | Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1: Postdose 1 Hr, Day 1 | 438.24 pg/mL | Standard Deviation 1658.63 |
| Placebo | Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 2: Predose 0 hrs, Day 85 | 158.60 pg/mL | Standard Deviation 131.94 |
| Placebo | Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1: Postdose 6 Hrs, Day 57 | 149.58 pg/mL | Standard Deviation 166.07 |
| Placebo | Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 2: Postdose 4 Hrs, Day 1 | 132.97 pg/mL | Standard Deviation 126.11 |
| Placebo | Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1+2: Predose 0 hrs, Day 85 | 184.03 pg/mL | Standard Deviation 187.86 |
| Placebo | Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1+2: Predose 0 hrs, Day 1 | 183.03 pg/mL | Standard Deviation 153.42 |
| Placebo | Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1+2: Postdose 3 Hrs, Day 85 | 128.21 pg/mL | Standard Deviation 147.42 |
| Placebo | Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1: Postdose 0.08 Hrs, Day 29 and Day 57 | 174.87 pg/mL | Standard Deviation 186 |
| Placebo | Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 2: Predose 0 hrs, Day 1 | 175.88 pg/mL | Standard Deviation 135.75 |
| Placebo | Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1: Postdose 3 Hrs, Day 85 | 128.21 pg/mL | Standard Deviation 147.42 |
| SUN11031 20 μg/kg | Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1+2: Postdose 4 Hrs, Day 1 | 1071.31 pg/mL | Standard Deviation 1124.55 |
| SUN11031 20 μg/kg | Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1: Predose 0 hrs, Day 1 | 351.53 pg/mL | Standard Deviation 1102.43 |
| SUN11031 20 μg/kg | Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 2: Predose 0 hrs, Day 1 | 754.23 pg/mL | Standard Deviation 3103.32 |
| SUN11031 20 μg/kg | Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1+2: Predose 0 hrs, Day 1 | 541.04 pg/mL | Standard Deviation 2265.36 |
| SUN11031 20 μg/kg | Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1: Predose 0 hrs, Day 85 | 196.17 pg/mL | Standard Deviation 131.67 |
| SUN11031 20 μg/kg | Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 2: Predose 0 hrs, Day 85 | 459.03 pg/mL | Standard Deviation 1059.43 |
| SUN11031 20 μg/kg | Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1+2: Predose 0 hrs, Day 85 | 317.86 pg/mL | Standard Deviation 731.38 |
| SUN11031 20 μg/kg | Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1: Postdose 0.08 Hrs, Day 29 and Day 57 | 5401.49 pg/mL | Standard Deviation 4793.51 |
| SUN11031 20 μg/kg | Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 2: Postdose 0.08 Hrs, Day 29 and Day 57 | 6560.23 pg/mL | Standard Deviation 4751.75 |
| SUN11031 20 μg/kg | Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1+2: Postdose 0.08 Hrs, Day 29 and Day 57 | 5884.30 pg/mL | Standard Deviation 4770.54 |
| SUN11031 20 μg/kg | Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 2: Postdose 0.5 Hrs, Day 85 | 6200.68 pg/mL | Standard Deviation 5045.86 |
| SUN11031 20 μg/kg | Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1+2: Postdose 0.5 Hrs, Day 85 | 6200.68 pg/mL | Standard Deviation 5045.86 |
| SUN11031 20 μg/kg | Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1: Postdose 1 Hr, Day 1 | 3071.61 pg/mL | Standard Deviation 2422.07 |
| SUN11031 20 μg/kg | Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1+2: Postdose 1 Hr, Day 1 | 3071.61 pg/mL | Standard Deviation 2422.07 |
| SUN11031 20 μg/kg | Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 2: Postdose 1.5 Hrs, Day 29 | 2230.16 pg/mL | Standard Deviation 1920.22 |
| SUN11031 20 μg/kg | Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1+2: Postdose 1.5 Hrs, Day 29 | 2230.16 pg/mL | Standard Deviation 1290.22 |
| SUN11031 20 μg/kg | Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1: Postdose 3 Hrs, Day 85 | 2381.54 pg/mL | Standard Deviation 4226.73 |
| SUN11031 20 μg/kg | Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1+2: Postdose 3 Hrs, Day 85 | 2381.54 pg/mL | Standard Deviation 4226.73 |
| SUN11031 20 μg/kg | Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 2: Postdose 4 Hrs, Day 1 | 1071.31 pg/mL | Standard Deviation 1124.55 |
| SUN11031 20 μg/kg | Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1: Postdose 6 Hrs, Day 57 | 577.37 pg/mL | Standard Deviation 632.84 |
| SUN11031 20 μg/kg | Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1+2: Postdose 6 Hrs, Day 57 | 577.37 pg/mL | Standard Deviation 632.84 |
| SUN11031 40 μg/kg | Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 2: Postdose 0.08 Hrs, Day 29 and Day 57 | 9519.43 pg/mL | Standard Deviation 8835.18 |
| SUN11031 40 μg/kg | Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 2: Predose 0 hrs, Day 1 | 234.63 pg/mL | Standard Deviation 225.77 |
| SUN11031 40 μg/kg | Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1+2: Postdose 1.5 Hrs, Day 29 | 4944.39 pg/mL | Standard Deviation 4285.93 |
| SUN11031 40 μg/kg | Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1: Postdose 0.08 Hrs, Day 29 and Day 57 | 8680.49 pg/mL | Standard Deviation 7747.93 |
| SUN11031 40 μg/kg | Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1+2: Postdose 6 Hrs, Day 57 | 914.64 pg/mL | Standard Deviation 769.17 |
| SUN11031 40 μg/kg | Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1: Postdose 3 Hrs, Day 85 | 2536.51 pg/mL | Standard Deviation 1949.44 |
| SUN11031 40 μg/kg | Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1+2: Predose 0 hrs, Day 85 | 886.97 pg/mL | Standard Deviation 3455.15 |
| SUN11031 40 μg/kg | Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1: Postdose 6 Hrs, Day 57 | 914.64 pg/mL | Standard Deviation 769.17 |
| SUN11031 40 μg/kg | Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1+2: Postdose 3 Hrs, Day 85 | 2536.51 pg/mL | Standard Deviation 1949.44 |
| SUN11031 40 μg/kg | Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 2: Predose 0 hrs, Day 85 | 824.12 pg/mL | Standard Deviation 3095.66 |
| SUN11031 40 μg/kg | Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1: Predose 0 hrs, Day 1 | 547.12 pg/mL | Standard Deviation 1276.89 |
| SUN11031 40 μg/kg | Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 2: Postdose 4 Hrs, Day 1 | 993.47 pg/mL | Standard Deviation 1167.56 |
| SUN11031 40 μg/kg | Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1+2: Postdose 0.5 Hrs, Day 85 | 10819.65 pg/mL | Standard Deviation 7950.18 |
| SUN11031 40 μg/kg | Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1: Predose 0 hrs, Day 85 | 951.98 pg/mL | Standard Deviation 3846.4 |
| SUN11031 40 μg/kg | Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1: Postdose 1 Hr, Day 1 | 7929.87 pg/mL | Standard Deviation 7053.81 |
| SUN11031 40 μg/kg | Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 2: Postdose 0.5 Hrs, Day 85 | 10819.65 pg/mL | Standard Deviation 7950.18 |
| SUN11031 40 μg/kg | Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1+2: Predose 0 hrs, Day 1 | 371.94 pg/mL | Standard Deviation 868.91 |
| SUN11031 40 μg/kg | Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1+2: Postdose 1 Hr, Day 1 | 7929.87 pg/mL | Standard Deviation 7053.81 |
| SUN11031 40 μg/kg | Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1+2: Postdose 0.08 Hrs, Day 29 and Day 57 | 9106.62 pg/mL | Standard Deviation 8261.72 |
| SUN11031 40 μg/kg | Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 1+2: Postdose 4 Hrs, Day 1 | 993.47 pg/mL | Standard Deviation 1167.56 |
| SUN11031 40 μg/kg | Absolute Concentrations of SUN11031 Metabolites Desacyl-ghrelin Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Seq 2: Postdose 1.5 Hrs, Day 29 | 4944.39 pg/mL | Standard Deviation 4285.93 |
Secondary
Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD)
Assessment of functional capacity in study participants with chronic obstructive pulmonary disease (COPD) via the 6-minute walk test (6MWT) provided an objective measure of disability. The 6MWT is a practical and objective evaluation of functional exercise capacity. The test measures the distance that a participant can quickly walk on a flat, hard surface in 6 minutes. In order to ensure uniformity among the sites, the specifications of the course for the 6MWT were modified from being 30 meters long with 60-meter laps to be 15 meters long with 30-meter laps to accommodate space limitations encountered at select sites.
Time frame: Baseline up to Day 29, Day 57, and Day 85 post dose.
Population: Distance walked during the 6 Minute Walk Test was assessed using the Intent-to-Treat population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Younger Than 65 years: Baseline | 353.89 meters | Standard Deviation 78.95 |
| Placebo | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Males: Change at Day 29 | 30.06 meters | Standard Deviation 50.34 |
| Placebo | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Males: Change at Day 57 | 30.41 meters | Standard Deviation 38.3 |
| Placebo | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Males: Change at Day 85 | 33.24 meters | Standard Deviation 49.15 |
| Placebo | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Females: Baseline | 318.94 meters | Standard Deviation 84.44 |
| Placebo | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Females: Change at Day 29 | 16.53 meters | Standard Deviation 63.69 |
| Placebo | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Females: Change at Day 57 | 24.34 meters | Standard Deviation 63.63 |
| Placebo | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Females: Change at Day 85 | 22.23 meters | Standard Deviation 61.6 |
| Placebo | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Males: Baseline | 316.07 meters | Standard Deviation 78.64 |
| Placebo | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Younger Than 65 years: Change at Day 29 | 33.30 meters | Standard Deviation 73.9 |
| Placebo | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Younger Than 65 years: Change at Day 57 | 36.50 meters | Standard Deviation 60.86 |
| Placebo | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Younger Than 65 years: Change at Day 85 | 31.29 meters | Standard Deviation 66.54 |
| Placebo | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | 65 Years and older: Baseline | 291.17 meters | Standard Deviation 71.88 |
| Placebo | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | 65 Years and older: Change at Day 29 | 17.87 meters | Standard Deviation 39.56 |
| Placebo | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | 65 Years and older: Change at Day 57 | 21.58 meters | Standard Deviation 41.16 |
| Placebo | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | 65 Years and older: Change at Day 85 | 26.51 meters | Standard Deviation 45.22 |
| Placebo | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Body Mass Index (BMI) <18.9 kg/m^2: Baseline | 313.28 meters | Standard Deviation 83.74 |
| Placebo | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Body Mass Index (BMI) <18.9 kg/m^2: Change at Day 29 | 15.78 meters | Standard Deviation 45.55 |
| Placebo | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Body Mass Index (BMI) <18.9 kg/m^2: Change at Day 57 | 17.06 meters | Standard Deviation 51.79 |
| Placebo | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Body Mass Index (BMI) <18.9 kg/m^2: Change at Day 85 | 14.51 meters | Standard Deviation 55.14 |
| Placebo | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Body Mass Index (BMI) ≥18.9 kg/m^2: Baseline | 322.33 meters | Standard Deviation 77.56 |
| Placebo | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Body Mass Index (BMI) ≥18.9 kg/m^2: Change at Day 29 | 34.93 meters | Standard Deviation 66.93 |
| Placebo | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Body Mass Index (BMI) ≥18.9 kg/m^2: Change at Day 57 | 41.22 meters | Standard Deviation 46.08 |
| Placebo | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Body Mass Index (BMI) ≥18.9 kg/m^2: Change at Day 85 | 45.99 meters | Standard Deviation 49.65 |
| Placebo | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Forced Expiratory Volume in 1 second (FEV1) <37% predicted: Baseline | 296.61 meters | Standard Deviation 82.27 |
| Placebo | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Forced Expiratory Volume in 1 second (FEV1) <37% predicted: Cange at Day 29 | 28.65 meters | Standard Deviation 48.12 |
| Placebo | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Forced Expiratory Volume in 1 second (FEV1) <37% predicted: Change at Day 57 | 27.67 meters | Standard Deviation 49.8 |
| Placebo | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Forced Expiratory Volume in 1 second (FEV1) <37% predicted: Change at Day 85 | 20.87 meters | Standard Deviation 51.34 |
| Placebo | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Forced Expiratory Volume in 1 second (FEV1) ≥37% predicted: Baseline | 340.43 meters | Standard Deviation 73.14 |
| Placebo | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Forced Expiratory Volume in 1 second (FEV1) ≥37% predicted: Change at Day 29 | 19.61 meters | Standard Deviation 64.46 |
| Placebo | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Forced Expiratory Volume in 1 second (FEV1) ≥37% predicted: Change at Day 57 | 27.93 meters | Standard Deviation 51.94 |
| Placebo | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Forced Expiratory Volume in 1 second (FEV1) ≥37% predicted: Change at Day 85 | 37.02 meters | Standard Deviation 57.85 |
| SUN11031 20 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Body Mass Index (BMI) ≥18.9 kg/m^2: Change at Day 29 | -0.76 meters | Standard Deviation 50.94 |
| SUN11031 20 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Males: Baseline | 336.24 meters | Standard Deviation 86.36 |
| SUN11031 20 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | 65 Years and older: Change at Day 29 | 0.47 meters | Standard Deviation 50.05 |
| SUN11031 20 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Body Mass Index (BMI) <18.9 kg/m^2: Baseline | 322.42 meters | Standard Deviation 85.37 |
| SUN11031 20 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Males: Change at Day 29 | -0.97 meters | Standard Deviation 53.57 |
| SUN11031 20 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | 65 Years and older: Baseline | 315.04 meters | Standard Deviation 81.14 |
| SUN11031 20 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Forced Expiratory Volume in 1 second (FEV1) ≥37% predicted: Change at Day 57 | 19.02 meters | Standard Deviation 37.19 |
| SUN11031 20 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Males: Change at Day 57 | 10.08 meters | Standard Deviation 54.74 |
| SUN11031 20 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Body Mass Index (BMI) <18.9 kg/m^2: Change at Day 29 | 6.46 meters | Standard Deviation 41.74 |
| SUN11031 20 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Body Mass Index (BMI) ≥18.9 kg/m^2: Change at Day 57 | 9.65 meters | Standard Deviation 49.15 |
| SUN11031 20 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Males: Change at Day 85 | 4.17 meters | Standard Deviation 61.9 |
| SUN11031 20 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Forced Expiratory Volume in 1 second (FEV1) ≥37% predicted: Change at Day 85 | 20.42 meters | Standard Deviation 43.24 |
| SUN11031 20 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Forced Expiratory Volume in 1 second (FEV1) <37% predicted: Change at Day 85 | -6.17 meters | Standard Deviation 58.31 |
| SUN11031 20 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Females: Baseline | 328.60 meters | Standard Deviation 59.58 |
| SUN11031 20 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Body Mass Index (BMI) <18.9 kg/m^2: Change at Day 57 | 9.67 meters | Standard Deviation 47.08 |
| SUN11031 20 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | 65 Years and older: Change at Day 57 | 7.59 meters | Standard Deviation 48.39 |
| SUN11031 20 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Females: Change at Day 29 | 11.55 meters | Standard Deviation 21.19 |
| SUN11031 20 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Younger Than 65 years: Change at Day 85 | 8.76 meters | Standard Deviation 46.19 |
| SUN11031 20 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Body Mass Index (BMI) ≥18.9 kg/m^2: Change at Day 85 | 6.47 meters | Standard Deviation 53.47 |
| SUN11031 20 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Females: Change at Day 57 | 8.70 meters | Standard Deviation 26.45 |
| SUN11031 20 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Body Mass Index (BMI) <18.9 kg/m^2: Change at Day 85 | 5.21 meters | Standard Deviation 54.06 |
| SUN11031 20 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Forced Expiratory Volume in 1 second (FEV1) <37% predicted: Change at Day 57 | 1.94 meters | Standard Deviation 54.31 |
| SUN11031 20 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Females: Change at Day 85 | 9.75 meters | Standard Deviation 25.06 |
| SUN11031 20 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | 65 Years and older: Change at Day 85 | 3.02 meters | Standard Deviation 60.08 |
| SUN11031 20 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Forced Expiratory Volume in 1 second (FEV1) ≥37% predicted: Change at Day 29 | 16.13 meters | Standard Deviation 34.82 |
| SUN11031 20 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Younger Than 65 years: Baseline | 353.35 meters | Standard Deviation 72.62 |
| SUN11031 20 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Body Mass Index (BMI) ≥18.9 kg/m^2: Baseline | 345.14 meters | Standard Deviation 71.47 |
| SUN11031 20 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Forced Expiratory Volume in 1 second (FEV1) <37% predicted: Baseline | 315.35 meters | Standard Deviation 89.66 |
| SUN11031 20 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Younger Than 65 years: Change at Day 29 | 5.19 meters | Standard Deviation 43.01 |
| SUN11031 20 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Forced Expiratory Volume in 1 second (FEV1) <37% predicted: Cange at Day 29 | -8.20 meters | Standard Deviation 52.1 |
| SUN11031 20 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Forced Expiratory Volume in 1 second (FEV1) ≥37% predicted: Baseline | 356.46 meters | Standard Deviation 57.08 |
| SUN11031 20 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Younger Than 65 years: Change at Day 57 | 11.79 meters | Standard Deviation 47.78 |
| SUN11031 40 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Females: Change at Day 85 | 7.75 meters | Standard Deviation 90.11 |
| SUN11031 40 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Forced Expiratory Volume in 1 second (FEV1) ≥37% predicted: Change at Day 29 | 14.82 meters | Standard Deviation 47.47 |
| SUN11031 40 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Younger Than 65 years: Change at Day 85 | 9.13 meters | Standard Deviation 81.6 |
| SUN11031 40 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | 65 Years and older: Baseline | 317.92 meters | Standard Deviation 63.29 |
| SUN11031 40 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Forced Expiratory Volume in 1 second (FEV1) <37% predicted: Cange at Day 29 | 16.31 meters | Standard Deviation 39.96 |
| SUN11031 40 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | 65 Years and older: Change at Day 29 | 4.92 meters | Standard Deviation 38 |
| SUN11031 40 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | 65 Years and older: Change at Day 57 | 12.14 meters | Standard Deviation 33.71 |
| SUN11031 40 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | 65 Years and older: Change at Day 85 | 10.75 meters | Standard Deviation 42.79 |
| SUN11031 40 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Forced Expiratory Volume in 1 second (FEV1) <37% predicted: Change at Day 57 | 15.52 meters | Standard Deviation 47.63 |
| SUN11031 40 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Body Mass Index (BMI) <18.9 kg/m^2: Baseline | 328.58 meters | Standard Deviation 74 |
| SUN11031 40 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Body Mass Index (BMI) <18.9 kg/m^2: Change at Day 29 | 16.31 meters | Standard Deviation 54.65 |
| SUN11031 40 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Body Mass Index (BMI) <18.9 kg/m^2: Change at Day 57 | 12.37 meters | Standard Deviation 54.52 |
| SUN11031 40 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Forced Expiratory Volume in 1 second (FEV1) <37% predicted: Change at Day 85 | 2.23 meters | Standard Deviation 80.61 |
| SUN11031 40 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Body Mass Index (BMI) <18.9 kg/m^2: Change at Day 85 | 24.99 meters | Standard Deviation 48.12 |
| SUN11031 40 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Forced Expiratory Volume in 1 second (FEV1) ≥37% predicted: Change at Day 57 | 18.79 meters | Standard Deviation 49.25 |
| SUN11031 40 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Body Mass Index (BMI) ≥18.9 kg/m^2: Baseline | 336.34 meters | Standard Deviation 64.94 |
| SUN11031 40 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Males: Baseline | 337.95 meters | Standard Deviation 64.1 |
| SUN11031 40 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Body Mass Index (BMI) ≥18.9 kg/m^2: Change at Day 29 | 14.81 meters | Standard Deviation 37.21 |
| SUN11031 40 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Males: Change at Day 29 | 11.56 meters | Standard Deviation 44.91 |
| SUN11031 40 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Forced Expiratory Volume in 1 second (FEV1) ≥37% predicted: Baseline | 342.25 meters | Standard Deviation 62.47 |
| SUN11031 40 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Males: Change at Day 57 | 11.13 meters | Standard Deviation 45.14 |
| SUN11031 40 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Males: Change at Day 85 | 11.05 meters | Standard Deviation 46.17 |
| SUN11031 40 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Body Mass Index (BMI) ≥18.9 kg/m^2: Change at Day 57 | 20.74 meters | Standard Deviation 44.18 |
| SUN11031 40 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Females: Baseline | 322.67 meters | Standard Deviation 77.39 |
| SUN11031 40 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Forced Expiratory Volume in 1 second (FEV1) ≥37% predicted: Change at Day 85 | 15.38 meters | Standard Deviation 45.94 |
| SUN11031 40 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Females: Change at Day 29 | 24.42 meters | Standard Deviation 42.91 |
| SUN11031 40 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Females: Change at Day 57 | 31.94 meters | Standard Deviation 53.09 |
| SUN11031 40 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Body Mass Index (BMI) ≥18.9 kg/m^2: Change at Day 85 | 0.44 meters | Standard Deviation 68.54 |
| SUN11031 40 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Younger Than 65 years: Change at Day 57 | 24.38 meters | Standard Deviation 62.35 |
| SUN11031 40 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Younger Than 65 years: Baseline | 353.30 meters | Standard Deviation 70.19 |
| SUN11031 40 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Younger Than 65 years: Change at Day 29 | 28.31 meters | Standard Deviation 48.78 |
| SUN11031 40 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Forced Expiratory Volume in 1 second (FEV1) <37% predicted: Baseline | 320.20 meters | Standard Deviation 75.06 |
Secondary
Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD)
Assessment of functional capacity in study participants with chronic obstructive pulmonary disease (COPD) via the 6-minute walk test (6MWT) provided an objective measure of disability. The 6MWT is a practical and objective evaluation of functional exercise capacity. The test measures the distance that a participant can quickly walk on a flat, hard surface in 6 minutes. In order to ensure uniformity among the sites, the specifications of the course for the 6MWT were modified from being 30 meters long with 60-meter laps to be 15 meters long with 30-meter laps to accommodate space limitations encountered at select sites.
Time frame: Baseline up to Day 29, Day 57, and Day 85 post dose.
Population: Distance walked during the 6 Minute Walk Test was assessed using the Intent-to-Treat population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Baseline | 317.30 meters | Standard Deviation 80.62 |
| Placebo | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Change at Day 29 | 24.26 meters | Standard Deviation 56.41 |
| Placebo | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Change at Day 57 | 27.80 meters | Standard Deviation 50.46 |
| Placebo | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Change at Day 85 | 28.50 meters | Standard Deviation 54.72 |
| SUN11031 20 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Change at Day 85 | 5.85 meters | Standard Deviation 53.38 |
| SUN11031 20 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Baseline | 333.93 meters | Standard Deviation 78.91 |
| SUN11031 20 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Change at Day 57 | 9.66 meters | Standard Deviation 47.8 |
| SUN11031 20 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Change at Day 29 | 2.80 meters | Standard Deviation 46.45 |
| SUN11031 40 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Change at Day 85 | 10.04 meters | Standard Deviation 62.16 |
| SUN11031 40 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Change at Day 29 | 15.40 meters | Standard Deviation 44.39 |
| SUN11031 40 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Change at Day 57 | 17.46 meters | Standard Deviation 48.27 |
| SUN11031 40 μg/kg | Mean Change From Baseline to Days 29, 57, and 85 in the Distance Walked During the 6 Minute Walk Test (MWT) Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease (COPD) | Baseline | 333.30 meters | Standard Deviation 68.2 |
Secondary
Mean Change in Body Weight From Baseline Through Day 99 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease
Measurements of body weight were performed in the morning when the participant had an empty stomach (ie, had consumed no food overnight) and had emptied the bladder and had a bowel movement, if possible. These measurements were performed using the same calibrated scale for an individual participant throughout study.
Time frame: Baseline up to Day 8, Day 15, Day 22, Day 29, Day 43, Day 57, Day 85, and Day 99 post dose.
Population: Mean change in body weight was assessed using the Intent-to-Treat population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change in Body Weight From Baseline Through Day 99 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Change at Day 57 | 0.66 kg | Standard Deviation 1.47 |
| Placebo | Mean Change in Body Weight From Baseline Through Day 99 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Change at Day 15 | 0.43 kg | Standard Deviation 0.93 |
| Placebo | Mean Change in Body Weight From Baseline Through Day 99 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Change at Day 99 | 0.84 kg | Standard Deviation 1.72 |
| Placebo | Mean Change in Body Weight From Baseline Through Day 99 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Change at Day 85 | 0.90 kg | Standard Deviation 1.71 |
| Placebo | Mean Change in Body Weight From Baseline Through Day 99 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Change at Day 22 | 0.44 kg | Standard Deviation 1.14 |
| Placebo | Mean Change in Body Weight From Baseline Through Day 99 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Change at Day 8 | 0.31 kg | Standard Deviation 0.72 |
| Placebo | Mean Change in Body Weight From Baseline Through Day 99 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Change at Day 43 | 0.48 kg | Standard Deviation 1.42 |
| Placebo | Mean Change in Body Weight From Baseline Through Day 99 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Change at Day 29 | 0.53 kg | Standard Deviation 1.23 |
| Placebo | Mean Change in Body Weight From Baseline Through Day 99 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Baseline | 48.93 kg | Standard Deviation 7.89 |
| SUN11031 20 μg/kg | Mean Change in Body Weight From Baseline Through Day 99 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Change at Day 85 | 1.75 kg | Standard Deviation 2.27 |
| SUN11031 20 μg/kg | Mean Change in Body Weight From Baseline Through Day 99 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Change at Day 22 | 1.36 kg | Standard Deviation 1.4 |
| SUN11031 20 μg/kg | Mean Change in Body Weight From Baseline Through Day 99 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Change at Day 29 | 1.43 kg | Standard Deviation 1.56 |
| SUN11031 20 μg/kg | Mean Change in Body Weight From Baseline Through Day 99 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Change at Day 43 | 1.62 kg | Standard Deviation 1.68 |
| SUN11031 20 μg/kg | Mean Change in Body Weight From Baseline Through Day 99 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Change at Day 57 | 1.62 kg | Standard Deviation 1.81 |
| SUN11031 20 μg/kg | Mean Change in Body Weight From Baseline Through Day 99 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Change at Day 99 | 1.38 kg | Standard Deviation 2.35 |
| SUN11031 20 μg/kg | Mean Change in Body Weight From Baseline Through Day 99 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Baseline | 50.63 kg | Standard Deviation 8.69 |
| SUN11031 20 μg/kg | Mean Change in Body Weight From Baseline Through Day 99 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Change at Day 8 | 0.78 kg | Standard Deviation 0.77 |
| SUN11031 20 μg/kg | Mean Change in Body Weight From Baseline Through Day 99 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Change at Day 15 | 1.09 kg | Standard Deviation 1.28 |
| SUN11031 40 μg/kg | Mean Change in Body Weight From Baseline Through Day 99 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Change at Day 43 | 2.03 kg | Standard Deviation 1.63 |
| SUN11031 40 μg/kg | Mean Change in Body Weight From Baseline Through Day 99 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Change at Day 22 | 1.68 kg | Standard Deviation 1.42 |
| SUN11031 40 μg/kg | Mean Change in Body Weight From Baseline Through Day 99 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Baseline | 53.16 kg | Standard Deviation 8.8 |
| SUN11031 40 μg/kg | Mean Change in Body Weight From Baseline Through Day 99 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Change at Day 29 | 1.86 kg | Standard Deviation 1.51 |
| SUN11031 40 μg/kg | Mean Change in Body Weight From Baseline Through Day 99 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Change at Day 15 | 1.34 kg | Standard Deviation 1.12 |
| SUN11031 40 μg/kg | Mean Change in Body Weight From Baseline Through Day 99 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Change at Day 85 | 2.44 kg | Standard Deviation 2.18 |
| SUN11031 40 μg/kg | Mean Change in Body Weight From Baseline Through Day 99 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Change at Day 57 | 2.15 kg | Standard Deviation 1.86 |
| SUN11031 40 μg/kg | Mean Change in Body Weight From Baseline Through Day 99 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Change at Day 8 | 1.00 kg | Standard Deviation 0.9 |
| SUN11031 40 μg/kg | Mean Change in Body Weight From Baseline Through Day 99 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Change at Day 99 | 1.88 kg | Standard Deviation 1.96 |
Secondary
Mean Change in Lean Body Mass From Baseline Through Days 29, 85 and 99 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease
Lean body mass was assessed based on whole-body dual-energy x-ray absorptiometry (DXA).
Time frame: Baseline up to Day 29, Day 85, and Day 99 post dose.
Population: Mean change in lean body mass was assessed using the Intent-to-Treat population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Change in Lean Body Mass From Baseline Through Days 29, 85 and 99 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Baseline | 37.85 kg | Standard Deviation 6.77 |
| Placebo | Mean Change in Lean Body Mass From Baseline Through Days 29, 85 and 99 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Change at Day 29 | 0.45 kg | Standard Deviation 0.95 |
| Placebo | Mean Change in Lean Body Mass From Baseline Through Days 29, 85 and 99 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Change at Day 85 | 0.29 kg | Standard Deviation 1.06 |
| Placebo | Mean Change in Lean Body Mass From Baseline Through Days 29, 85 and 99 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Change at Day 99 | 0.22 kg | Standard Deviation 1.16 |
| SUN11031 20 μg/kg | Mean Change in Lean Body Mass From Baseline Through Days 29, 85 and 99 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Change at Day 99 | 0.90 kg | Standard Deviation 1.27 |
| SUN11031 20 μg/kg | Mean Change in Lean Body Mass From Baseline Through Days 29, 85 and 99 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Baseline | 39.25 kg | Standard Deviation 7.75 |
| SUN11031 20 μg/kg | Mean Change in Lean Body Mass From Baseline Through Days 29, 85 and 99 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Change at Day 85 | 1.36 kg | Standard Deviation 1.24 |
| SUN11031 20 μg/kg | Mean Change in Lean Body Mass From Baseline Through Days 29, 85 and 99 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Change at Day 29 | 1.12 kg | Standard Deviation 1.13 |
| SUN11031 40 μg/kg | Mean Change in Lean Body Mass From Baseline Through Days 29, 85 and 99 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Change at Day 99 | 0.74 kg | Standard Deviation 1.55 |
| SUN11031 40 μg/kg | Mean Change in Lean Body Mass From Baseline Through Days 29, 85 and 99 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Change at Day 29 | 1.32 kg | Standard Deviation 1.01 |
| SUN11031 40 μg/kg | Mean Change in Lean Body Mass From Baseline Through Days 29, 85 and 99 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Change at Day 85 | 1.44 kg | Standard Deviation 1.5 |
| SUN11031 40 μg/kg | Mean Change in Lean Body Mass From Baseline Through Days 29, 85 and 99 Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Baseline | 40.39 kg | Standard Deviation 6.8 |
Secondary
Number of Participants With Improvement in Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease
Assessment of functional capacity in study participants with chronic obstructive pulmonary disease (COPD) via the 6-minute walk test (6MWT) provided an objective measure of disability. The 6MWT is a practical and objective evaluation of functional exercise capacity. The test measures the distance that a participant can quickly walk on a flat, hard surface in 6 minutes. In order to ensure uniformity among the sites, the specifications of the course for the 6MWT were modified from being 30 meters long with 60-meter laps to be 15 meters long with 30-meter laps to accommodate space limitations encountered at select sites.
Time frame: Baseline up to Day 85 post dose.
Population: The number of participants with improved walking distance was assessed using the Intent-to-Treat population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Improvement in Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | ≥20 meter improvement at Day 85 : BMI <18.9 kg/m^2 | 17 participants |
| Placebo | Number of Participants With Improvement in Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | ≥20 meter improvement at Day 85 : Females | 17 participants |
| Placebo | Number of Participants With Improvement in Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | ≥20 meter improvement at Day 85 : Younger than 65 years | 15 participants |
| Placebo | Number of Participants With Improvement in Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | ≥20 meter improvement at Day 85 : 65 Years and older | 23 participants |
| Placebo | Number of Participants With Improvement in Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | ≥20 meter improvement at Day 85 : Males | 21 participants |
| Placebo | Number of Participants With Improvement in Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | ≥20 meter improvement at Day 85 : BMI ≥18.9 kg/m^2 | 21 participants |
| Placebo | Number of Participants With Improvement in Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | ≥20 meter improvement at Day 85 : Forced Expiratory Volume in 1 second (FEV1) <37% predicted | 16 participants |
| Placebo | Number of Participants With Improvement in Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | ≥20 meter improvement at Day 85 : Forced Expiratory Volume in 1 second (FEV1) ≥37% predicted | 22 participants |
| Placebo | Number of Participants With Improvement in Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | ≥10 meter improvement at Day 85 : Males | 28 participants |
| Placebo | Number of Participants With Improvement in Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | ≥10 meter improvement at Day 85 : Females | 22 participants |
| Placebo | Number of Participants With Improvement in Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | ≥10 meter improvement at Day 85 : Younger than 65 years | 20 participants |
| Placebo | Number of Participants With Improvement in Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | ≥10 meter improvement at Day 85 : 65 Years and older | 30 participants |
| Placebo | Number of Participants With Improvement in Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | ≥10 meter improvement at Day 85 : BMI <18.9 kg/m^2 | 24 participants |
| Placebo | Number of Participants With Improvement in Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | ≥10 meter improvement at Day 85 : BMI ≥18.9 kg/m^2 | 26 participants |
| Placebo | Number of Participants With Improvement in Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | ≥10 meter improvement at Day 85 : Forced Expiratory Volume in 1 second (FEV1) <37% predicted | 24 participants |
| Placebo | Number of Participants With Improvement in Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | ≥10 meter improvement at Day 85 : Forced Expiratory Volume in 1 second (FEV1) ≥37% predicted | 26 participants |
| SUN11031 20 μg/kg | Number of Participants With Improvement in Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | ≥20 meter improvement at Day 85 : BMI ≥18.9 kg/m^2 | 14 participants |
| SUN11031 20 μg/kg | Number of Participants With Improvement in Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | ≥20 meter improvement at Day 85 : Forced Expiratory Volume in 1 second (FEV1) <37% predicted | 11 participants |
| SUN11031 20 μg/kg | Number of Participants With Improvement in Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | ≥20 meter improvement at Day 85 : Forced Expiratory Volume in 1 second (FEV1) ≥37% predicted | 15 participants |
| SUN11031 20 μg/kg | Number of Participants With Improvement in Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | ≥10 meter improvement at Day 85 : BMI ≥18.9 kg/m^2 | 18 participants |
| SUN11031 20 μg/kg | Number of Participants With Improvement in Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | ≥10 meter improvement at Day 85 : Males | 24 participants |
| SUN11031 20 μg/kg | Number of Participants With Improvement in Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | ≥10 meter improvement at Day 85 : Females | 10 participants |
| SUN11031 20 μg/kg | Number of Participants With Improvement in Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | ≥10 meter improvement at Day 85 : Forced Expiratory Volume in 1 second (FEV1) ≥37% predicted | 18 participants |
| SUN11031 20 μg/kg | Number of Participants With Improvement in Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | ≥10 meter improvement at Day 85 : Younger than 65 years | 17 participants |
| SUN11031 20 μg/kg | Number of Participants With Improvement in Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | ≥20 meter improvement at Day 85 : Males | 30 participants |
| SUN11031 20 μg/kg | Number of Participants With Improvement in Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | ≥10 meter improvement at Day 85 : Forced Expiratory Volume in 1 second (FEV1) <37% predicted | 16 participants |
| SUN11031 20 μg/kg | Number of Participants With Improvement in Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | ≥20 meter improvement at Day 85 : Females | 6 participants |
| SUN11031 20 μg/kg | Number of Participants With Improvement in Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | ≥10 meter improvement at Day 85 : 65 Years and older | 17 participants |
| SUN11031 20 μg/kg | Number of Participants With Improvement in Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | ≥20 meter improvement at Day 85 : Younger than 65 years | 13 participants |
| SUN11031 20 μg/kg | Number of Participants With Improvement in Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | ≥20 meter improvement at Day 85 : 65 Years and older | 13 participants |
| SUN11031 20 μg/kg | Number of Participants With Improvement in Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | ≥20 meter improvement at Day 85 : BMI <18.9 kg/m^2 | 12 participants |
| SUN11031 20 μg/kg | Number of Participants With Improvement in Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | ≥10 meter improvement at Day 85 : BMI <18.9 kg/m^2 | 16 participants |
| SUN11031 40 μg/kg | Number of Participants With Improvement in Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | ≥10 meter improvement at Day 85 : Younger than 65 years | 19 participants |
| SUN11031 40 μg/kg | Number of Participants With Improvement in Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | ≥20 meter improvement at Day 85 : BMI ≥18.9 kg/m^2 | 16 participants |
| SUN11031 40 μg/kg | Number of Participants With Improvement in Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | ≥10 meter improvement at Day 85 : BMI <18.9 kg/m^2 | 19 participants |
| SUN11031 40 μg/kg | Number of Participants With Improvement in Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | ≥20 meter improvement at Day 85 : Younger than 65 years | 15 participants |
| SUN11031 40 μg/kg | Number of Participants With Improvement in Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | ≥20 meter improvement at Day 85 : Forced Expiratory Volume in 1 second (FEV1) <37% predicted | 14 participants |
| SUN11031 40 μg/kg | Number of Participants With Improvement in Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | ≥10 meter improvement at Day 85 : Forced Expiratory Volume in 1 second (FEV1) ≥37% predicted | 25 participants |
| SUN11031 40 μg/kg | Number of Participants With Improvement in Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | ≥20 meter improvement at Day 85 : Males | 22 participants |
| SUN11031 40 μg/kg | Number of Participants With Improvement in Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | ≥20 meter improvement at Day 85 : Forced Expiratory Volume in 1 second (FEV1) ≥37% predicted | 20 participants |
| SUN11031 40 μg/kg | Number of Participants With Improvement in Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | ≥10 meter improvement at Day 85 : 65 Years and older | 21 participants |
| SUN11031 40 μg/kg | Number of Participants With Improvement in Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | ≥20 meter improvement at Day 85 : BMI <18.9 kg/m^2 | 18 participants |
| SUN11031 40 μg/kg | Number of Participants With Improvement in Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | ≥10 meter improvement at Day 85 : Males | 26 participants |
| SUN11031 40 μg/kg | Number of Participants With Improvement in Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | ≥10 meter improvement at Day 85 : BMI ≥18.9 kg/m^2 | 21 participants |
| SUN11031 40 μg/kg | Number of Participants With Improvement in Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | ≥20 meter improvement at Day 85 : Females | 12 participants |
| SUN11031 40 μg/kg | Number of Participants With Improvement in Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | ≥10 meter improvement at Day 85 : Females | 14 participants |
| SUN11031 40 μg/kg | Number of Participants With Improvement in Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | ≥20 meter improvement at Day 85 : 65 Years and older | 19 participants |
| SUN11031 40 μg/kg | Number of Participants With Improvement in Distance Walked During the 6 Minute Walk Test (MWT) By Sub-groups Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | ≥10 meter improvement at Day 85 : Forced Expiratory Volume in 1 second (FEV1) <37% predicted | 15 participants |
Secondary
Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that occurred from the time treatment was administered at Day 1 through the last follow-up visit or a worsening of a pre-existing condition.
Time frame: Baseline up to Day 113 post dose, up to a total of 134 days.
Population: Treatment-emergent adverse events were assessed using the safety population.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Influenza | 2 Participants |
| Placebo | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Weight decreased | 3 Participants |
| Placebo | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Abdominal pain upper | 0 Participants |
| Placebo | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Contusion | 0 Participants |
| Placebo | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Hepatic enzyme increased | 1 Participants |
| Placebo | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Toothache | 2 Participants |
| Placebo | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Insomnia | 1 Participants |
| Placebo | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Muscle spasms | 0 Participants |
| Placebo | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Abdominal pain | 1 Participants |
| Placebo | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Pneumonia | 1 Participants |
| Placebo | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Dry mouth | 1 Participants |
| Placebo | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Dyspnea | 1 Participants |
| Placebo | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Myalgia | 2 Participants |
| Placebo | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Vomiting | 2 Participants |
| Placebo | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Hyperkalemia | 1 Participants |
| Placebo | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Arthralgia | 1 Participants |
| Placebo | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Injection site hematoma | 7 Participants |
| Placebo | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Gastroenteritis | 2 Participants |
| Placebo | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Back pain | 1 Participants |
| Placebo | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Injection site pain | 2 Participants |
| Placebo | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Cholecystitis | 0 Participants |
| Placebo | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Thirst | 0 Participants |
| Placebo | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Chest pain | 1 Participants |
| Placebo | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Hyperglycemia | 2 Participants |
| Placebo | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Asthenia | 3 Participants |
| Placebo | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Urinary tract infection | 2 Participants |
| Placebo | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Hyperhidrosis | 0 Participants |
| Placebo | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Sinus tachycardia | 0 Participants |
| Placebo | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | upper respiratory tract infection | 3 Participants |
| Placebo | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Bronchitis | 4 Participants |
| Placebo | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Orthostatic hypotension | 0 Participants |
| Placebo | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Pharyngitis | 1 Participants |
| Placebo | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | COPD | 23 Participants |
| Placebo | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Hypotension | 2 Participants |
| Placebo | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Sinusitis | 2 Participants |
| Placebo | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Depression | 0 Participants |
| Placebo | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Hypertension | 4 Participants |
| Placebo | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Tonsillitis | 2 Participants |
| Placebo | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Nasopharyngitis | 1 Participants |
| Placebo | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Dizziness | 1 Participants |
| Placebo | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Oral herpes | 2 Participants |
| Placebo | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Number of Participants with at least 1 TEAE | 58 Participants |
| Placebo | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Headache | 5 Participants |
| Placebo | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Diarrhea | 7 Participants |
| Placebo | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Somnolence | 2 Participants |
| Placebo | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Electrocardiogram QT prolonged | 2 Participants |
| Placebo | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Nausea | 3 Participants |
| SUN11031 20 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Hypertension | 1 Participants |
| SUN11031 20 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Number of Participants with at least 1 TEAE | 59 Participants |
| SUN11031 20 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | COPD | 20 Participants |
| SUN11031 20 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Dyspnea | 2 Participants |
| SUN11031 20 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Bronchitis | 5 Participants |
| SUN11031 20 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Nasopharyngitis | 6 Participants |
| SUN11031 20 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Influenza | 3 Participants |
| SUN11031 20 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Pneumonia | 2 Participants |
| SUN11031 20 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Gastroenteritis | 2 Participants |
| SUN11031 20 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Urinary tract infection | 1 Participants |
| SUN11031 20 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | upper respiratory tract infection | 1 Participants |
| SUN11031 20 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Pharyngitis | 0 Participants |
| SUN11031 20 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Sinusitis | 1 Participants |
| SUN11031 20 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Tonsillitis | 1 Participants |
| SUN11031 20 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Oral herpes | 0 Participants |
| SUN11031 20 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Diarrhea | 2 Participants |
| SUN11031 20 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Nausea | 1 Participants |
| SUN11031 20 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Abdominal pain upper | 4 Participants |
| SUN11031 20 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Toothache | 0 Participants |
| SUN11031 20 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Abdominal pain | 2 Participants |
| SUN11031 20 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Dry mouth | 0 Participants |
| SUN11031 20 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Vomiting | 0 Participants |
| SUN11031 20 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Injection site hematoma | 3 Participants |
| SUN11031 20 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Injection site pain | 4 Participants |
| SUN11031 20 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Chest pain | 2 Participants |
| SUN11031 20 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Asthenia | 0 Participants |
| SUN11031 20 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Thirst | 0 Participants |
| SUN11031 20 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Back pain | 4 Participants |
| SUN11031 20 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Arthralgia | 1 Participants |
| SUN11031 20 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Myalgia | 2 Participants |
| SUN11031 20 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Muscle spasms | 1 Participants |
| SUN11031 20 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Hepatic enzyme increased | 2 Participants |
| SUN11031 20 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Weight decreased | 6 Participants |
| SUN11031 20 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Electrocardiogram QT prolonged | 0 Participants |
| SUN11031 20 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Headache | 4 Participants |
| SUN11031 20 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Dizziness | 2 Participants |
| SUN11031 20 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Hypotension | 1 Participants |
| SUN11031 20 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Orthostatic hypotension | 2 Participants |
| SUN11031 20 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Sinus tachycardia | 2 Participants |
| SUN11031 20 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Hyperglycemia | 2 Participants |
| SUN11031 20 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Hyperkalemia | 2 Participants |
| SUN11031 20 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Insomnia | 0 Participants |
| SUN11031 20 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Somnolence | 0 Participants |
| SUN11031 20 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Depression | 0 Participants |
| SUN11031 20 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Hyperhidrosis | 2 Participants |
| SUN11031 20 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Contusion | 0 Participants |
| SUN11031 20 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Cholecystitis | 0 Participants |
| SUN11031 40 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Nasopharyngitis | 2 Participants |
| SUN11031 40 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Weight decreased | 4 Participants |
| SUN11031 40 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Diarrhea | 1 Participants |
| SUN11031 40 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Cholecystitis | 2 Participants |
| SUN11031 40 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Electrocardiogram QT prolonged | 1 Participants |
| SUN11031 40 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Oral herpes | 0 Participants |
| SUN11031 40 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Somnolence | 1 Participants |
| SUN11031 40 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Headache | 5 Participants |
| SUN11031 40 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Tonsillitis | 0 Participants |
| SUN11031 40 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Bronchitis | 3 Participants |
| SUN11031 40 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Dizziness | 3 Participants |
| SUN11031 40 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Sinusitis | 0 Participants |
| SUN11031 40 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Abdominal pain | 0 Participants |
| SUN11031 40 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Hypertension | 1 Participants |
| SUN11031 40 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Pharyngitis | 2 Participants |
| SUN11031 40 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Contusion | 2 Participants |
| SUN11031 40 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Hypotension | 1 Participants |
| SUN11031 40 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | upper respiratory tract infection | 2 Participants |
| SUN11031 40 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Depression | 2 Participants |
| SUN11031 40 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Orthostatic hypotension | 0 Participants |
| SUN11031 40 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Urinary tract infection | 3 Participants |
| SUN11031 40 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Dyspnea | 3 Participants |
| SUN11031 40 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Sinus tachycardia | 0 Participants |
| SUN11031 40 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Gastroenteritis | 2 Participants |
| SUN11031 40 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Number of Participants with at least 1 TEAE | 56 Participants |
| SUN11031 40 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Chest pain | 1 Participants |
| SUN11031 40 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Hyperglycemia | 1 Participants |
| SUN11031 40 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Asthenia | 1 Participants |
| SUN11031 40 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Injection site pain | 2 Participants |
| SUN11031 40 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Pneumonia | 3 Participants |
| SUN11031 40 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Thirst | 2 Participants |
| SUN11031 40 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Injection site hematoma | 7 Participants |
| SUN11031 40 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Hyperhidrosis | 4 Participants |
| SUN11031 40 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Back pain | 3 Participants |
| SUN11031 40 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Vomiting | 1 Participants |
| SUN11031 40 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Hyperkalemia | 0 Participants |
| SUN11031 40 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Arthralgia | 2 Participants |
| SUN11031 40 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Dry mouth | 2 Participants |
| SUN11031 40 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Influenza | 3 Participants |
| SUN11031 40 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Myalgia | 0 Participants |
| SUN11031 40 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Toothache | 2 Participants |
| SUN11031 40 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | COPD | 16 Participants |
| SUN11031 40 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Muscle spasms | 2 Participants |
| SUN11031 40 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Abdominal pain upper | 3 Participants |
| SUN11031 40 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Insomnia | 4 Participants |
| SUN11031 40 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Hepatic enzyme increased | 0 Participants |
| SUN11031 40 μg/kg | Treatment Emergent Adverse Events Reported in ≥ 2% of Participants Following Treatment With SUN11031 in Participants Having Cachexia Associated With Chronic Obstructive Pulmonary Disease | Nausea | 5 Participants |