Type 2 Diabetes Mellitus
Conditions
Brief summary
The main purpose of this study is to assess the safety and tolerability of LY3025876 given alone (Part A) and in combination with liraglutide (Part B) in participants with type 2 diabetes mellitus (T2DM).
Detailed description
This study will also evaluate how much of the study drug enters the blood stream and how long it takes for the body to remove the study drug. Information about any side effects that may occur will also be collected. Participants will continue their usual diet and exercise program and may remain on their physician-prescribed dose of metformin. Each part of the study is expected to last 10 to 12 weeks on average, not including screening. Participants may only enroll in one part.
Interventions
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of type 2 diabetes mellitus (T2DM) as determined by the investigator, controlled with diet or exercise alone or on a stable dose of metformin for at least 30 days * Have a body mass index (BMI) greater than or equal to 23 and less than or equal to 45 kilograms per square meter (kg/m\^2) at screening * Have a supine blood pressure reading at screening of between 90-160 millimeter of mercury (mmHg) (systolic) and 40-95 mmHg (diastolic) * Women not of child-bearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause
Exclusion criteria
* Have taken LY3025876 or investigational drugs like it (for example, other fibroblast growth factor-21 \[FGF21\]-related drugs) or have known allergies to these drugs * History or presence of bone disease (including osteoporosis or unhealed fractures) * Current active treatment of periodontal disease * Have had a significant change in weight, defined as a gain or loss of at least 4 kilogram (kg) (9 pounds) in the last 3 months * Have had greater than 1 episode of severe hypoglycemia within 6 months of screening that required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions or had a seizure or coma * Have known allergies or a history of intolerance to liraglutide, glucagon-like peptide 1 (GLP-1) analogues, or other related compounds * Have a history of acute or chronic pancreatitis * Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | Predose on Day 1 up to Day 56 in each Part | A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time 0 to 24 Hours (AUC[0-24]) of LY3025876 | Predose and 0.5 hour(hr), 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 12 hr, and 24 hr Postdose | AUC(0-24) of individual participants was calculated by equation Area Under Concentration (AUC)=Dose/CL, where the clearance (CL) was estimated using a population PK model. |
| PK: Maximum Concentration (Cmax) of LY3025876 | Days 1 and 28: Predose and 0.5 hr, 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 12 hr, and 24 hr Postdose | — |
| Part A and Part B: Immunogenicity: The Number of Participants With Anti-LY3025876 Antibodies | Predose on Day 7, 14, 28, 56, and 180 | — |
| Pharmacodynamics (PD): Change From Baseline to Day 28 in Fasting Glucose | Baseline, Day 28 | Least Squares Mean (LS) Mean change from baseline in fasting glucose was modeled using Mixed Effect Model Repeat Measurement (MMRM) analysis with fixed effects of baseline, treatment, day, treatment\*day interaction, and participant as a random effect. |
Countries
United States
Participant flow
Pre-assignment details
Dose escalation was planned for 20 milligrams (mg) of LY3025876 but dose escalation was only up to 15 mg LY3025876.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Part A Part A Placebo for LY3025876 administered as QD SQ injections for up to 28 days. | 11 |
| 0.5 mg LY3025876 Part A: 0.5 mg of LY3025876 administered as QD SQ injections for up to 28 days. | 15 |
| 1.5 mg LY3025876 Part A: 1.5 mg of LY3025876 administered as QD SQ injections for up to 28 days. | 8 |
| 5.0 mg LY3025876 Part A: 5.0 mg of LY3025876 administered as QD SQ injections for up to 28 days. | 9 |
| 15 mg LY3025876 Part A: 15 mg of LY3025876 administered as QD SQ injections for up to 28 days. | 10 |
| Placebo + Liraglutide Part B: Placebo doses matching LY3025876 and 1.8 mg liraglutide administered as separate QD SQ injections for up to 28 days, after titration of liraglutide over 2 weeks. | 9 |
| 5.0 mg LY3025876 + Liraglutide Part B:5.0 mg LY3025876 and 1.8 mg liraglutide administered as separate QD SQ injections for up to 28 days, after titration of liraglutide over 2 weeks. | 10 |
| Total | 72 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 0 | 2 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Sponsor Decision | 0 | 6 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 0 | 0 | 1 | 1 | 1 |
Baseline characteristics
| Characteristic | Placebo Part A | 0.5 mg LY3025876 | 1.5 mg LY3025876 | 5.0 mg LY3025876 | 15 mg LY3025876 | Placebo + Liraglutide | 5.0 mg LY3025876 + Liraglutide | Total |
|---|---|---|---|---|---|---|---|---|
| Age, Continuous Age Part A | 53.4 years STANDARD_DEVIATION 9.6 | 55.8 years STANDARD_DEVIATION 7.6 | 53.3 years STANDARD_DEVIATION 7.2 | 61.9 years STANDARD_DEVIATION 5.5 | 55.3 years STANDARD_DEVIATION 6.8 | NA years | NA years | 55.8 years STANDARD_DEVIATION 7.8 |
| Age, Continuous Age Part B | NA years | NA years | NA years | NA years | NA years | 53.2 years STANDARD_DEVIATION 8.9 | 54.4 years STANDARD_DEVIATION 5.5 | 53.8 years STANDARD_DEVIATION 7.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants | 13 Participants | 7 Participants | 6 Participants | 6 Participants | 6 Participants | 3 Participants | 51 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 2 Participants | 1 Participants | 3 Participants | 4 Participants | 3 Participants | 7 Participants | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Fasting Serum Glucose (FSG) FSG Part A | 164.43 milligram/deciliter (mg/dL) STANDARD_DEVIATION 31.59 | 148.08 milligram/deciliter (mg/dL) STANDARD_DEVIATION 19.14 | 181.27 milligram/deciliter (mg/dL) STANDARD_DEVIATION 47.84 | 175.74 milligram/deciliter (mg/dL) STANDARD_DEVIATION 75.99 | 145.66 milligram/deciliter (mg/dL) STANDARD_DEVIATION 23.22 | NA milligram/deciliter (mg/dL) | NA milligram/deciliter (mg/dL) | 161.63 milligram/deciliter (mg/dL) STANDARD_DEVIATION 42.87 |
| Fasting Serum Glucose (FSG) FSG Part B | NA milligram/deciliter (mg/dL) | NA milligram/deciliter (mg/dL) | NA milligram/deciliter (mg/dL) | NA milligram/deciliter (mg/dL) | NA milligram/deciliter (mg/dL) | 159.73 milligram/deciliter (mg/dL) STANDARD_DEVIATION 36.54 | 152.22 milligram/deciliter (mg/dL) STANDARD_DEVIATION 26.62 | 155.78 milligram/deciliter (mg/dL) STANDARD_DEVIATION 31.02 |
| Glycosylated Hemoglobin (HbA1c) HbA1c Part A | 8.64 percent of HbA1c STANDARD_DEVIATION 0.65 | 8.39 percent of HbA1c STANDARD_DEVIATION 0.93 | 8.43 percent of HbA1c STANDARD_DEVIATION 0.88 | 8.94 percent of HbA1c STANDARD_DEVIATION 1.19 | 8.67 percent of HbA1c STANDARD_DEVIATION 0.92 | NA percent of HbA1c | NA percent of HbA1c | 8.59 percent of HbA1c STANDARD_DEVIATION 0.91 |
| Glycosylated Hemoglobin (HbA1c) HbA1c Part B | NA percent of HbA1c | NA percent of HbA1c | NA percent of HbA1c | NA percent of HbA1c | NA percent of HbA1c | 8.56 percent of HbA1c STANDARD_DEVIATION 0.77 | 8.05 percent of HbA1c STANDARD_DEVIATION 0.86 | 8.29 percent of HbA1c STANDARD_DEVIATION 0.84 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 4 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 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 | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 11 Participants | 13 Participants | 8 Participants | 7 Participants | 10 Participants | 8 Participants | 5 Participants | 62 Participants |
| Region of Enrollment United States | 11 participants | 15 participants | 8 participants | 9 participants | 10 participants | 9 participants | 10 participants | 72 participants |
| Sex: Female, Male Female | 4 Participants | 5 Participants | 4 Participants | 2 Participants | 2 Participants | 2 Participants | 3 Participants | 22 Participants |
| Sex: Female, Male Male | 7 Participants | 10 Participants | 4 Participants | 7 Participants | 8 Participants | 7 Participants | 7 Participants | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 5 / 11 | 7 / 15 | 8 / 8 | 9 / 9 | 10 / 10 | 9 / 9 | 9 / 10 |
| serious Total, serious adverse events | 0 / 11 | 0 / 15 | 0 / 8 | 0 / 9 | 0 / 10 | 0 / 9 | 0 / 10 |
Outcome results
Primary
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.
Time frame: Predose on Day 1 up to Day 56 in each Part
Population: All randomized participants who received at least one dose of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo Part A | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 participants |
| 0.5 mg LY3025876 | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 participants |
| 1.5 mg LY3025876 | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 participants |
| 5.0 mg LY3025876 | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 participants |
| 15 mg LY3025876 | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 participants |
| Placebo + Liraglutide | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 participants |
| 5.0 mg LY3025876 + Liraglutide | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | 0 participants |
Secondary
Part A and Part B: Immunogenicity: The Number of Participants With Anti-LY3025876 Antibodies
Time frame: Predose on Day 7, 14, 28, 56, and 180
Population: All randomized participants who received at least one dose of study drug in Part A and Part B.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Placebo Part A | Part A and Part B: Immunogenicity: The Number of Participants With Anti-LY3025876 Antibodies | Positive Antibodies Day 28 | 0 Participants |
| Placebo Part A | Part A and Part B: Immunogenicity: The Number of Participants With Anti-LY3025876 Antibodies | Positive Antibodies Day 7 | 0 Participants |
| Placebo Part A | Part A and Part B: Immunogenicity: The Number of Participants With Anti-LY3025876 Antibodies | Positive Antibodies Day 180 | 0 Participants |
| Placebo Part A | Part A and Part B: Immunogenicity: The Number of Participants With Anti-LY3025876 Antibodies | Positive Antibodies Day 14 | 0 Participants |
| Placebo Part A | Part A and Part B: Immunogenicity: The Number of Participants With Anti-LY3025876 Antibodies | Positive Antibodies Day 56 | 0 Participants |
| 0.5 mg LY3025876 | Part A and Part B: Immunogenicity: The Number of Participants With Anti-LY3025876 Antibodies | Positive Antibodies Day 28 | 1 Participants |
| 0.5 mg LY3025876 | Part A and Part B: Immunogenicity: The Number of Participants With Anti-LY3025876 Antibodies | Positive Antibodies Day 14 | 1 Participants |
| 0.5 mg LY3025876 | Part A and Part B: Immunogenicity: The Number of Participants With Anti-LY3025876 Antibodies | Positive Antibodies Day 56 | 1 Participants |
| 0.5 mg LY3025876 | Part A and Part B: Immunogenicity: The Number of Participants With Anti-LY3025876 Antibodies | Positive Antibodies Day 7 | 0 Participants |
| 0.5 mg LY3025876 | Part A and Part B: Immunogenicity: The Number of Participants With Anti-LY3025876 Antibodies | Positive Antibodies Day 180 | 0 Participants |
| 1.5 mg LY3025876 | Part A and Part B: Immunogenicity: The Number of Participants With Anti-LY3025876 Antibodies | Positive Antibodies Day 180 | 0 Participants |
| 1.5 mg LY3025876 | Part A and Part B: Immunogenicity: The Number of Participants With Anti-LY3025876 Antibodies | Positive Antibodies Day 14 | 0 Participants |
| 1.5 mg LY3025876 | Part A and Part B: Immunogenicity: The Number of Participants With Anti-LY3025876 Antibodies | Positive Antibodies Day 7 | 0 Participants |
| 1.5 mg LY3025876 | Part A and Part B: Immunogenicity: The Number of Participants With Anti-LY3025876 Antibodies | Positive Antibodies Day 28 | 2 Participants |
| 1.5 mg LY3025876 | Part A and Part B: Immunogenicity: The Number of Participants With Anti-LY3025876 Antibodies | Positive Antibodies Day 56 | 4 Participants |
| 5.0 mg LY3025876 | Part A and Part B: Immunogenicity: The Number of Participants With Anti-LY3025876 Antibodies | Positive Antibodies Day 28 | 2 Participants |
| 5.0 mg LY3025876 | Part A and Part B: Immunogenicity: The Number of Participants With Anti-LY3025876 Antibodies | Positive Antibodies Day 7 | 0 Participants |
| 5.0 mg LY3025876 | Part A and Part B: Immunogenicity: The Number of Participants With Anti-LY3025876 Antibodies | Positive Antibodies Day 14 | 0 Participants |
| 5.0 mg LY3025876 | Part A and Part B: Immunogenicity: The Number of Participants With Anti-LY3025876 Antibodies | Positive Antibodies Day 56 | 2 Participants |
| 5.0 mg LY3025876 | Part A and Part B: Immunogenicity: The Number of Participants With Anti-LY3025876 Antibodies | Positive Antibodies Day 180 | 1 Participants |
| 15 mg LY3025876 | Part A and Part B: Immunogenicity: The Number of Participants With Anti-LY3025876 Antibodies | Positive Antibodies Day 7 | 1 Participants |
| 15 mg LY3025876 | Part A and Part B: Immunogenicity: The Number of Participants With Anti-LY3025876 Antibodies | Positive Antibodies Day 180 | 4 Participants |
| 15 mg LY3025876 | Part A and Part B: Immunogenicity: The Number of Participants With Anti-LY3025876 Antibodies | Positive Antibodies Day 28 | 6 Participants |
| 15 mg LY3025876 | Part A and Part B: Immunogenicity: The Number of Participants With Anti-LY3025876 Antibodies | Positive Antibodies Day 56 | 6 Participants |
| 15 mg LY3025876 | Part A and Part B: Immunogenicity: The Number of Participants With Anti-LY3025876 Antibodies | Positive Antibodies Day 14 | 0 Participants |
| Placebo + Liraglutide | Part A and Part B: Immunogenicity: The Number of Participants With Anti-LY3025876 Antibodies | Positive Antibodies Day 7 | 0 Participants |
| Placebo + Liraglutide | Part A and Part B: Immunogenicity: The Number of Participants With Anti-LY3025876 Antibodies | Positive Antibodies Day 180 | 0 Participants |
| Placebo + Liraglutide | Part A and Part B: Immunogenicity: The Number of Participants With Anti-LY3025876 Antibodies | Positive Antibodies Day 56 | 0 Participants |
| Placebo + Liraglutide | Part A and Part B: Immunogenicity: The Number of Participants With Anti-LY3025876 Antibodies | Positive Antibodies Day 14 | 0 Participants |
| Placebo + Liraglutide | Part A and Part B: Immunogenicity: The Number of Participants With Anti-LY3025876 Antibodies | Positive Antibodies Day 28 | 0 Participants |
| 5.0 mg LY3025876 + Liraglutide | Part A and Part B: Immunogenicity: The Number of Participants With Anti-LY3025876 Antibodies | Positive Antibodies Day 56 | 1 Participants |
| 5.0 mg LY3025876 + Liraglutide | Part A and Part B: Immunogenicity: The Number of Participants With Anti-LY3025876 Antibodies | Positive Antibodies Day 14 | 1 Participants |
| 5.0 mg LY3025876 + Liraglutide | Part A and Part B: Immunogenicity: The Number of Participants With Anti-LY3025876 Antibodies | Positive Antibodies Day 28 | 1 Participants |
| 5.0 mg LY3025876 + Liraglutide | Part A and Part B: Immunogenicity: The Number of Participants With Anti-LY3025876 Antibodies | Positive Antibodies Day 7 | 1 Participants |
| 5.0 mg LY3025876 + Liraglutide | Part A and Part B: Immunogenicity: The Number of Participants With Anti-LY3025876 Antibodies | Positive Antibodies Day 180 | 0 Participants |
Secondary
Pharmacodynamics (PD): Change From Baseline to Day 28 in Fasting Glucose
Least Squares Mean (LS) Mean change from baseline in fasting glucose was modeled using Mixed Effect Model Repeat Measurement (MMRM) analysis with fixed effects of baseline, treatment, day, treatment\*day interaction, and participant as a random effect.
Time frame: Baseline, Day 28
Population: All randomized participants who received one dose of study drug and had evaluable PD data baseline and at least 1 post-baseline data in fasting glucose.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Part A | Pharmacodynamics (PD): Change From Baseline to Day 28 in Fasting Glucose | 3.52 milligram/deciliter (mg/dL) | Standard Error 8.41 |
| 0.5 mg LY3025876 | Pharmacodynamics (PD): Change From Baseline to Day 28 in Fasting Glucose | 18.08 milligram/deciliter (mg/dL) | Standard Error 10.02 |
| 1.5 mg LY3025876 | Pharmacodynamics (PD): Change From Baseline to Day 28 in Fasting Glucose | 0.12 milligram/deciliter (mg/dL) | Standard Error 9.92 |
| 5.0 mg LY3025876 | Pharmacodynamics (PD): Change From Baseline to Day 28 in Fasting Glucose | -14.50 milligram/deciliter (mg/dL) | Standard Error 9.33 |
| 15 mg LY3025876 | Pharmacodynamics (PD): Change From Baseline to Day 28 in Fasting Glucose | 22.96 milligram/deciliter (mg/dL) | Standard Error 11.51 |
| Placebo + Liraglutide | Pharmacodynamics (PD): Change From Baseline to Day 28 in Fasting Glucose | 11.72 milligram/deciliter (mg/dL) | Standard Error 5.94 |
| 5.0 mg LY3025876 + Liraglutide | Pharmacodynamics (PD): Change From Baseline to Day 28 in Fasting Glucose | 6.32 milligram/deciliter (mg/dL) | Standard Error 5.64 |
Secondary
Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time 0 to 24 Hours (AUC[0-24]) of LY3025876
AUC(0-24) of individual participants was calculated by equation Area Under Concentration (AUC)=Dose/CL, where the clearance (CL) was estimated using a population PK model.
Time frame: Predose and 0.5 hour(hr), 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 12 hr, and 24 hr Postdose
Population: All randomized participants who received at least one dose of study drug and had evaluable AUC 0-24 PK data.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Placebo Part A | Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time 0 to 24 Hours (AUC[0-24]) of LY3025876 | 51.5 nanograms*hour/milliliter (ng*hr/mL) | Geometric Coefficient of Variation 61.1 |
| 0.5 mg LY3025876 | Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time 0 to 24 Hours (AUC[0-24]) of LY3025876 | 207 nanograms*hour/milliliter (ng*hr/mL) | Geometric Coefficient of Variation 51.2 |
| 1.5 mg LY3025876 | Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time 0 to 24 Hours (AUC[0-24]) of LY3025876 | 622 nanograms*hour/milliliter (ng*hr/mL) | Geometric Coefficient of Variation 42.3 |
| 5.0 mg LY3025876 | Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time 0 to 24 Hours (AUC[0-24]) of LY3025876 | 1930 nanograms*hour/milliliter (ng*hr/mL) | Geometric Coefficient of Variation 32.4 |
| 15 mg LY3025876 | Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time 0 to 24 Hours (AUC[0-24]) of LY3025876 | 525 nanograms*hour/milliliter (ng*hr/mL) | Geometric Coefficient of Variation 37.8 |
Secondary
PK: Maximum Concentration (Cmax) of LY3025876
Time frame: Days 1 and 28: Predose and 0.5 hr, 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 12 hr, and 24 hr Postdose
Population: All randomized participants who received at least one dose of study drug and had evaluable Cmax PK data.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo Part A | PK: Maximum Concentration (Cmax) of LY3025876 | Day 28 | 4.87 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 85.7 |
| Placebo Part A | PK: Maximum Concentration (Cmax) of LY3025876 | Day 1 | 3.90 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 33.7 |
| 0.5 mg LY3025876 | PK: Maximum Concentration (Cmax) of LY3025876 | Day 28 | 14.2 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 46.1 |
| 0.5 mg LY3025876 | PK: Maximum Concentration (Cmax) of LY3025876 | Day 1 | 17.5 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 43.7 |
| 1.5 mg LY3025876 | PK: Maximum Concentration (Cmax) of LY3025876 | Day 1 | 45.1 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 39.2 |
| 1.5 mg LY3025876 | PK: Maximum Concentration (Cmax) of LY3025876 | Day 28 | 51.9 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 31.3 |
| 5.0 mg LY3025876 | PK: Maximum Concentration (Cmax) of LY3025876 | Day 28 | 185 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 26.8 |
| 5.0 mg LY3025876 | PK: Maximum Concentration (Cmax) of LY3025876 | Day 1 | 126 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 44.3 |
| 15 mg LY3025876 | PK: Maximum Concentration (Cmax) of LY3025876 | Day 1 | 40.3 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 48.3 |
| 15 mg LY3025876 | PK: Maximum Concentration (Cmax) of LY3025876 | Day 28 | 44.8 nanogram/milliliter (ng/mL) | Geometric Coefficient of Variation 53.8 |