Gastroparesis
Conditions
Keywords
Diabetic Gastroparesis
Brief summary
This open-label study is to assess the safety of continued treatment with relamorelin for participants who previously completed the RLM-MD-03 \[NCT03420781\] or RLM-MD-04 \[NCT03383146\] study and to provide treatment for these participants until relamorelin becomes commercially available or the Sponsor terminates development.
Interventions
DRUGRelamorelin 10 μg
Relamorelin 10 μg injected subcutaneously twice daily.
Sponsors
Allergan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Successful completion of either Study RLM-MD-03 or Study RLM-MD-04 * Ability to provide written informed consent (IC) prior to any study procedures and willingness and ability to comply with study procedures * Demonstration of adequate compliance with the study procedures in Study RLM-MD-03 or RLM-MD-04, in the opinion of the investigator.
Exclusion criteria
* Participant is planning to receive an investigational drug (other than study intervention) or investigational device at any time during Study 3071-305-020 * Participant has an unresolved adverse event (AE) from a lead-in study, ie, a clinically significant finding on physical examination, clinical laboratory test, or 12-lead electrocardiogram (ECG) that, in the investigator's opinion, would limit the participant's ability to participate in or complete the study * Any other reason that, in the investigator's opinion, would confound proper interpretation of the study or expose a participant to unacceptable risk, including renal, hepatic, or cardiopulmonary disease * Females who are pregnant, nursing, or planning a pregnancy during the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAEs) | Up to approximately 22 months | An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE is an AE that begins or worsens after receiving study drug. |
| Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Baseline (Day 1) up to approximately 22 months | Clinical Laboratory tests included hematology, chemistry and urinalysis tests. The investigator determined if the results were clinically significant. Only those categories where at least 1 person had a non-PCS value at Baseline and met the PCS criterion at least once during postbaseline are reported. |
| Number of Participants With Clinically Meaningful Trends for Vital Signs | Up to approximately 22 months | Vital Signs included assessments of heart rate, respiratory rate, systolic and diastolic blood pressure, and body temperature. The investigator determined if the abnormal results were clinically significant. |
| Number of Participants With Clinically Meaningful Trends in Electrocardiogram (ECG) Results | Up to approximately 22 months | A standard 12-lead ECG was performed. The investigator determined if the abnormal results were clinically significant. |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Colombia, Denmark, France, Germany, Hungary, India, Israel, Italy, Latvia, Malaysia, Mexico, Philippines, Poland, Romania, Russia, Singapore, South Africa, South Korea, Spain, Thailand, Ukraine, United Kingdom, United States
Participant flow
Pre-assignment details
Participants who completed relamorelin studies: RLM-MD-03 \[NCT03420781\] and RLM-MD-04 \[NCT03383146\] were eligible to enroll in this open-label safety study.
Participants by arm
| Arm | Count |
|---|---|
| Relamorelin/Relamorelin/Relamorelin Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in the 40-week placebo-controlled treatment period and relamorelin 10 μg in the 6-week RWP of RLM-MD-03. | 35 |
| Relamorelin/Placebo/Relamorelin Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in the 40-week placebo-controlled treatment period and placebo-matching relamorelin in the 6-week RWP of RLM-MD-03. | 22 |
| Placebo/Relamorelin/Relamorelin Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received placebo-matching relamorelin in the 40-week placebo-controlled treatment period and relamorelin 10 μg in the 6-week RWP of RLM-MD-03. | 54 |
| Relamorelin/Relamorelin Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received relamorelin 10 μg in double-blind treatment period of RLM-MD-04 for up to 52 weeks. | 63 |
| Placebo/Relamorelin Relamorelin 10 μg injected subcutaneously twice daily for up to approximately 22 months in this study. Participants in this arm group received placebo-matching relamorelin in the double-blind treatment period of RLM-MD-04 for up to 52 weeks. | 28 |
| Total | 202 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 0 | 3 | 1 |
| Overall Study | Lack of Efficacy | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Lost to Follow-up | 3 | 0 | 1 | 2 | 0 |
| Overall Study | Physician Decision | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Reason Not Specified | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Study Terminated by the Sponsor | 30 | 20 | 50 | 57 | 23 |
| Overall Study | Withdrawal by Subject | 1 | 2 | 2 | 1 | 2 |
Baseline characteristics
| Characteristic | Relamorelin/Relamorelin/Relamorelin | Relamorelin/Placebo/Relamorelin | Placebo/Relamorelin/Relamorelin | Relamorelin/Relamorelin | Placebo/Relamorelin | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 59.0 years STANDARD_DEVIATION 9.6 | 63.4 years STANDARD_DEVIATION 11.87 | 55.7 years STANDARD_DEVIATION 10.36 | 57.3 years STANDARD_DEVIATION 9.19 | 58.5 years STANDARD_DEVIATION 10.44 | 58.1 years STANDARD_DEVIATION 10.17 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 15 Participants | 8 Participants | 25 Participants | 16 Participants | 6 Participants | 70 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 14 Participants | 29 Participants | 47 Participants | 22 Participants | 132 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 3 Participants | 11 Participants | 13 Participants | 8 Participants | 37 Participants |
| Race (NIH/OMB) More than one race | 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 |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 31 Participants | 18 Participants | 43 Participants | 48 Participants | 20 Participants | 160 Participants |
| Sex: Female, Male Female | 26 Participants | 14 Participants | 38 Participants | 46 Participants | 22 Participants | 146 Participants |
| Sex: Female, Male Male | 9 Participants | 8 Participants | 16 Participants | 17 Participants | 6 Participants | 56 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 |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 22 | 0 / 54 | 0 / 63 | 0 / 28 |
| other Total, other adverse events | 10 / 35 | 6 / 22 | 15 / 54 | 10 / 62 | 7 / 28 |
| serious Total, serious adverse events | 2 / 35 | 3 / 22 | 7 / 54 | 2 / 62 | 0 / 28 |
Outcome results
Primary
Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE is an AE that begins or worsens after receiving study drug.
Time frame: Up to approximately 22 months
Population: Safety Population included all participants who received ≥1 administration of study treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Relamorelin/Relamorelin/Relamorelin | Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAEs) | 16 Participants |
| Relamorelin/Placebo/Relamorelin | Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAEs) | 11 Participants |
| Placebo/Relamorelin/Relamorelin | Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAEs) | 27 Participants |
| Relamorelin/Relamorelin | Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAEs) | 27 Participants |
| Placebo/Relamorelin | Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAEs) | 16 Participants |
Primary
Number of Participants With Clinically Meaningful Trends for Vital Signs
Vital Signs included assessments of heart rate, respiratory rate, systolic and diastolic blood pressure, and body temperature. The investigator determined if the abnormal results were clinically significant.
Time frame: Up to approximately 22 months
Population: Safety Population included all participants who received ≥1 administration of study treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Relamorelin/Relamorelin/Relamorelin | Number of Participants With Clinically Meaningful Trends for Vital Signs | 0 Participants |
| Relamorelin/Placebo/Relamorelin | Number of Participants With Clinically Meaningful Trends for Vital Signs | 0 Participants |
| Placebo/Relamorelin/Relamorelin | Number of Participants With Clinically Meaningful Trends for Vital Signs | 0 Participants |
| Relamorelin/Relamorelin | Number of Participants With Clinically Meaningful Trends for Vital Signs | 0 Participants |
| Placebo/Relamorelin | Number of Participants With Clinically Meaningful Trends for Vital Signs | 0 Participants |
Primary
Number of Participants With Clinically Meaningful Trends in Electrocardiogram (ECG) Results
A standard 12-lead ECG was performed. The investigator determined if the abnormal results were clinically significant.
Time frame: Up to approximately 22 months
Population: Safety Population included all participants who received ≥1 administration of study treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Relamorelin/Relamorelin/Relamorelin | Number of Participants With Clinically Meaningful Trends in Electrocardiogram (ECG) Results | 0 Participants |
| Relamorelin/Placebo/Relamorelin | Number of Participants With Clinically Meaningful Trends in Electrocardiogram (ECG) Results | 0 Participants |
| Placebo/Relamorelin/Relamorelin | Number of Participants With Clinically Meaningful Trends in Electrocardiogram (ECG) Results | 0 Participants |
| Relamorelin/Relamorelin | Number of Participants With Clinically Meaningful Trends in Electrocardiogram (ECG) Results | 0 Participants |
| Placebo/Relamorelin | Number of Participants With Clinically Meaningful Trends in Electrocardiogram (ECG) Results | 0 Participants |
Primary
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results
Clinical Laboratory tests included hematology, chemistry and urinalysis tests. The investigator determined if the results were clinically significant. Only those categories where at least 1 person had a non-PCS value at Baseline and met the PCS criterion at least once during postbaseline are reported.
Time frame: Baseline (Day 1) up to approximately 22 months
Population: Safety Population included all participants who received ≥1 administration of study treatment. Number analyzed is the number of participants with non-PCS baseline values and at least one post-baseline assessment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Relamorelin/Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Neutrophils Absolute Cell Count (10^9/L): <0.8×LLN | 1 Participants |
| Relamorelin/Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Hematocrit (RATIO): >1.1×ULN | 0 Participants |
| Relamorelin/Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Hematocrit (RATIO): <0.9×Lower Limit of Normal Value (LLN) | 1 Participants |
| Relamorelin/Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Hemoglobin [grams (g)/L]: <0.9×LLN | 2 Participants |
| Relamorelin/Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Lymphocytes Absolute Cell Count (10^9/L): >1.5×ULN | 0 Participants |
| Relamorelin/Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Lymphocytes Absolute Cell Count (10^9/L): <0.8×LLN | 0 Participants |
| Relamorelin/Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Mean Corpuscular Volume [femtoliter(fL)]: >1.1×ULN | 0 Participants |
| Relamorelin/Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Neutrophils Absolute Cell Count (10^9/L): >1.5×ULN | 1 Participants |
| Relamorelin/Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Eosinophils Absolute Cell Count [10^9/liter (L)]: >3×Upper Limit of Normal Value (ULN) | 0 Participants |
| Relamorelin/Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Red Blood Cell Count (10^12/L): <0.9×LLN | 1 Participants |
| Relamorelin/Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | White Blood Cell Count (10^9/L): <0.7×LLN | 0 Participants |
| Relamorelin/Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Alanine Aminotransferase [Serum Glutamic Pyruvic Transaminase (SGPT)] [unit(U)/L]: >=3×ULN | 1 Participants |
| Relamorelin/Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Aspartate Aminotransferase [Serum Glutamic Oxaloacetic Transaminase (SGOT)] (U/L): >=3×ULN | 1 Participants |
| Relamorelin/Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Bicarbonate (HCO3) [millimoles (mmol)/L]: >1.1×ULN | 1 Participants |
| Relamorelin/Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Bicarbonate (HCO3) (mmol/L): <0.9×LLN | 1 Participants |
| Relamorelin/Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Blood Urea Nitrogen (mmol/L): >1.2×ULN | 7 Participants |
| Relamorelin/Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Calcium (mmol/L): >1.1×ULN | 0 Participants |
| Relamorelin/Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Calcium (mmol/L): <0.9×LLN | 1 Participants |
| Relamorelin/Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Chloride (mmol/L): <0.9×LLN | 0 Participants |
| Relamorelin/Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Cholesterol, Total, Fasting (mmol/L): >1.6×ULN | 1 Participants |
| Relamorelin/Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Creatinine [micromoles(μmol)/L]: >1.3×ULN | 0 Participants |
| Relamorelin/Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Glucose-Chemistry, Fasting (mmol/L): >2.5×ULN | 5 Participants |
| Relamorelin/Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Glucose-Chemistry, Fasting (mmol/L): <0.9×LLN | 0 Participants |
| Relamorelin/Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Glycohemoglobin A1C (%): Increase of >=0.5% | 18 Participants |
| Relamorelin/Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Glycohemoglobin A1C (%): Increase of >=1% | 18 Participants |
| Relamorelin/Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Phosphorus (mmol/L): >1.1×ULN | 4 Participants |
| Relamorelin/Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Phosphorus (mmol/L): <0.9×LLN | 0 Participants |
| Relamorelin/Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Potassium (mmol/L): <0.9×LLN | 0 Participants |
| Relamorelin/Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Protein, Total (g/L): <0.9×LLN | 1 Participants |
| Relamorelin/Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Triglycerides, Fasting (mmol/L): >=3×ULN | 2 Participants |
| Relamorelin/Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Uric Acid (Urate) (μmol/L): >1.1×ULN | 4 Participants |
| Relamorelin/Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Uric Acid (Urate) (μmol/L): <0.9×LLN | 1 Participants |
| Relamorelin/Placebo/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Bicarbonate (HCO3) (mmol/L): <0.9×LLN | 0 Participants |
| Relamorelin/Placebo/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Chloride (mmol/L): <0.9×LLN | 0 Participants |
| Relamorelin/Placebo/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Protein, Total (g/L): <0.9×LLN | 1 Participants |
| Relamorelin/Placebo/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Bicarbonate (HCO3) [millimoles (mmol)/L]: >1.1×ULN | 0 Participants |
| Relamorelin/Placebo/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Potassium (mmol/L): <0.9×LLN | 0 Participants |
| Relamorelin/Placebo/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Triglycerides, Fasting (mmol/L): >=3×ULN | 2 Participants |
| Relamorelin/Placebo/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Calcium (mmol/L): <0.9×LLN | 0 Participants |
| Relamorelin/Placebo/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Neutrophils Absolute Cell Count (10^9/L): <0.8×LLN | 1 Participants |
| Relamorelin/Placebo/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Lymphocytes Absolute Cell Count (10^9/L): <0.8×LLN | 1 Participants |
| Relamorelin/Placebo/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Calcium (mmol/L): >1.1×ULN | 0 Participants |
| Relamorelin/Placebo/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Blood Urea Nitrogen (mmol/L): >1.2×ULN | 3 Participants |
| Relamorelin/Placebo/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Hematocrit (RATIO): <0.9×Lower Limit of Normal Value (LLN) | 1 Participants |
| Relamorelin/Placebo/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Hematocrit (RATIO): >1.1×ULN | 0 Participants |
| Relamorelin/Placebo/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Lymphocytes Absolute Cell Count (10^9/L): >1.5×ULN | 0 Participants |
| Relamorelin/Placebo/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Red Blood Cell Count (10^12/L): <0.9×LLN | 2 Participants |
| Relamorelin/Placebo/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Neutrophils Absolute Cell Count (10^9/L): >1.5×ULN | 1 Participants |
| Relamorelin/Placebo/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Eosinophils Absolute Cell Count [10^9/liter (L)]: >3×Upper Limit of Normal Value (ULN) | 1 Participants |
| Relamorelin/Placebo/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Phosphorus (mmol/L): >1.1×ULN | 0 Participants |
| Relamorelin/Placebo/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Glycohemoglobin A1C (%): Increase of >=1% | 18 Participants |
| Relamorelin/Placebo/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | White Blood Cell Count (10^9/L): <0.7×LLN | 0 Participants |
| Relamorelin/Placebo/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Mean Corpuscular Volume [femtoliter(fL)]: >1.1×ULN | 0 Participants |
| Relamorelin/Placebo/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Glycohemoglobin A1C (%): Increase of >=0.5% | 18 Participants |
| Relamorelin/Placebo/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Uric Acid (Urate) (μmol/L): >1.1×ULN | 6 Participants |
| Relamorelin/Placebo/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Glucose-Chemistry, Fasting (mmol/L): <0.9×LLN | 2 Participants |
| Relamorelin/Placebo/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Alanine Aminotransferase [Serum Glutamic Pyruvic Transaminase (SGPT)] [unit(U)/L]: >=3×ULN | 0 Participants |
| Relamorelin/Placebo/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Hemoglobin [grams (g)/L]: <0.9×LLN | 5 Participants |
| Relamorelin/Placebo/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Glucose-Chemistry, Fasting (mmol/L): >2.5×ULN | 2 Participants |
| Relamorelin/Placebo/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Creatinine [micromoles(μmol)/L]: >1.3×ULN | 3 Participants |
| Relamorelin/Placebo/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Uric Acid (Urate) (μmol/L): <0.9×LLN | 1 Participants |
| Relamorelin/Placebo/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Aspartate Aminotransferase [Serum Glutamic Oxaloacetic Transaminase (SGOT)] (U/L): >=3×ULN | 1 Participants |
| Relamorelin/Placebo/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Phosphorus (mmol/L): <0.9×LLN | 0 Participants |
| Relamorelin/Placebo/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Cholesterol, Total, Fasting (mmol/L): >1.6×ULN | 0 Participants |
| Placebo/Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Glucose-Chemistry, Fasting (mmol/L): <0.9×LLN | 4 Participants |
| Placebo/Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Neutrophils Absolute Cell Count (10^9/L): >1.5×ULN | 1 Participants |
| Placebo/Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Neutrophils Absolute Cell Count (10^9/L): <0.8×LLN | 0 Participants |
| Placebo/Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Potassium (mmol/L): <0.9×LLN | 1 Participants |
| Placebo/Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Red Blood Cell Count (10^12/L): <0.9×LLN | 4 Participants |
| Placebo/Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | White Blood Cell Count (10^9/L): <0.7×LLN | 0 Participants |
| Placebo/Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Alanine Aminotransferase [Serum Glutamic Pyruvic Transaminase (SGPT)] [unit(U)/L]: >=3×ULN | 0 Participants |
| Placebo/Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Aspartate Aminotransferase [Serum Glutamic Oxaloacetic Transaminase (SGOT)] (U/L): >=3×ULN | 0 Participants |
| Placebo/Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Bicarbonate (HCO3) [millimoles (mmol)/L]: >1.1×ULN | 1 Participants |
| Placebo/Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Protein, Total (g/L): <0.9×LLN | 0 Participants |
| Placebo/Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Bicarbonate (HCO3) (mmol/L): <0.9×LLN | 1 Participants |
| Placebo/Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Blood Urea Nitrogen (mmol/L): >1.2×ULN | 10 Participants |
| Placebo/Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Calcium (mmol/L): >1.1×ULN | 1 Participants |
| Placebo/Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Uric Acid (Urate) (μmol/L): <0.9×LLN | 3 Participants |
| Placebo/Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Calcium (mmol/L): <0.9×LLN | 0 Participants |
| Placebo/Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Chloride (mmol/L): <0.9×LLN | 1 Participants |
| Placebo/Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Triglycerides, Fasting (mmol/L): >=3×ULN | 1 Participants |
| Placebo/Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Cholesterol, Total, Fasting (mmol/L): >1.6×ULN | 1 Participants |
| Placebo/Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Creatinine [micromoles(μmol)/L]: >1.3×ULN | 5 Participants |
| Placebo/Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Glucose-Chemistry, Fasting (mmol/L): >2.5×ULN | 12 Participants |
| Placebo/Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Mean Corpuscular Volume [femtoliter(fL)]: >1.1×ULN | 1 Participants |
| Placebo/Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Glycohemoglobin A1C (%): Increase of >=0.5% | 41 Participants |
| Placebo/Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Uric Acid (Urate) (μmol/L): >1.1×ULN | 9 Participants |
| Placebo/Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Glycohemoglobin A1C (%): Increase of >=1% | 41 Participants |
| Placebo/Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Phosphorus (mmol/L): >1.1×ULN | 3 Participants |
| Placebo/Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Eosinophils Absolute Cell Count [10^9/liter (L)]: >3×Upper Limit of Normal Value (ULN) | 0 Participants |
| Placebo/Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Hematocrit (RATIO): >1.1×ULN | 1 Participants |
| Placebo/Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Hematocrit (RATIO): <0.9×Lower Limit of Normal Value (LLN) | 3 Participants |
| Placebo/Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Hemoglobin [grams (g)/L]: <0.9×LLN | 11 Participants |
| Placebo/Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Phosphorus (mmol/L): <0.9×LLN | 0 Participants |
| Placebo/Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Lymphocytes Absolute Cell Count (10^9/L): >1.5×ULN | 0 Participants |
| Placebo/Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Lymphocytes Absolute Cell Count (10^9/L): <0.8×LLN | 0 Participants |
| Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Phosphorus (mmol/L): >1.1×ULN | 2 Participants |
| Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Red Blood Cell Count (10^12/L): <0.9×LLN | 0 Participants |
| Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Phosphorus (mmol/L): <0.9×LLN | 2 Participants |
| Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Eosinophils Absolute Cell Count [10^9/liter (L)]: >3×Upper Limit of Normal Value (ULN) | 0 Participants |
| Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Glucose-Chemistry, Fasting (mmol/L): <0.9×LLN | 2 Participants |
| Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Triglycerides, Fasting (mmol/L): >=3×ULN | 1 Participants |
| Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Alanine Aminotransferase [Serum Glutamic Pyruvic Transaminase (SGPT)] [unit(U)/L]: >=3×ULN | 0 Participants |
| Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | White Blood Cell Count (10^9/L): <0.7×LLN | 0 Participants |
| Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Hematocrit (RATIO): >1.1×ULN | 1 Participants |
| Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Cholesterol, Total, Fasting (mmol/L): >1.6×ULN | 1 Participants |
| Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Glycohemoglobin A1C (%): Increase of >=0.5% | 37 Participants |
| Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Protein, Total (g/L): <0.9×LLN | 0 Participants |
| Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Glucose-Chemistry, Fasting (mmol/L): >2.5×ULN | 7 Participants |
| Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Neutrophils Absolute Cell Count (10^9/L): <0.8×LLN | 0 Participants |
| Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Blood Urea Nitrogen (mmol/L): >1.2×ULN | 4 Participants |
| Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Hemoglobin [grams (g)/L]: <0.9×LLN | 3 Participants |
| Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Potassium (mmol/L): <0.9×LLN | 0 Participants |
| Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Bicarbonate (HCO3) (mmol/L): <0.9×LLN | 1 Participants |
| Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Mean Corpuscular Volume [femtoliter(fL)]: >1.1×ULN | 0 Participants |
| Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Calcium (mmol/L): >1.1×ULN | 0 Participants |
| Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Lymphocytes Absolute Cell Count (10^9/L): >1.5×ULN | 1 Participants |
| Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Hematocrit (RATIO): <0.9×Lower Limit of Normal Value (LLN) | 3 Participants |
| Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Glycohemoglobin A1C (%): Increase of >=1% | 36 Participants |
| Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Aspartate Aminotransferase [Serum Glutamic Oxaloacetic Transaminase (SGOT)] (U/L): >=3×ULN | 0 Participants |
| Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Calcium (mmol/L): <0.9×LLN | 0 Participants |
| Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Uric Acid (Urate) (μmol/L): <0.9×LLN | 0 Participants |
| Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Bicarbonate (HCO3) [millimoles (mmol)/L]: >1.1×ULN | 0 Participants |
| Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Uric Acid (Urate) (μmol/L): >1.1×ULN | 8 Participants |
| Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Creatinine [micromoles(μmol)/L]: >1.3×ULN | 7 Participants |
| Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Chloride (mmol/L): <0.9×LLN | 0 Participants |
| Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Lymphocytes Absolute Cell Count (10^9/L): <0.8×LLN | 1 Participants |
| Relamorelin/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Neutrophils Absolute Cell Count (10^9/L): >1.5×ULN | 0 Participants |
| Placebo/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Hematocrit (RATIO): <0.9×Lower Limit of Normal Value (LLN) | 1 Participants |
| Placebo/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Cholesterol, Total, Fasting (mmol/L): >1.6×ULN | 0 Participants |
| Placebo/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Alanine Aminotransferase [Serum Glutamic Pyruvic Transaminase (SGPT)] [unit(U)/L]: >=3×ULN | 0 Participants |
| Placebo/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Creatinine [micromoles(μmol)/L]: >1.3×ULN | 3 Participants |
| Placebo/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Triglycerides, Fasting (mmol/L): >=3×ULN | 3 Participants |
| Placebo/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Hemoglobin [grams (g)/L]: <0.9×LLN | 2 Participants |
| Placebo/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Glucose-Chemistry, Fasting (mmol/L): >2.5×ULN | 4 Participants |
| Placebo/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Potassium (mmol/L): <0.9×LLN | 0 Participants |
| Placebo/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Lymphocytes Absolute Cell Count (10^9/L): <0.8×LLN | 0 Participants |
| Placebo/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Glucose-Chemistry, Fasting (mmol/L): <0.9×LLN | 0 Participants |
| Placebo/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | White Blood Cell Count (10^9/L): <0.7×LLN | 1 Participants |
| Placebo/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Uric Acid (Urate) (μmol/L): <0.9×LLN | 0 Participants |
| Placebo/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Glycohemoglobin A1C (%): Increase of >=0.5% | 24 Participants |
| Placebo/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Phosphorus (mmol/L): <0.9×LLN | 0 Participants |
| Placebo/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Glycohemoglobin A1C (%): Increase of >=1% | 24 Participants |
| Placebo/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Red Blood Cell Count (10^12/L): <0.9×LLN | 0 Participants |
| Placebo/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Lymphocytes Absolute Cell Count (10^9/L): >1.5×ULN | 0 Participants |
| Placebo/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Eosinophils Absolute Cell Count [10^9/liter (L)]: >3×Upper Limit of Normal Value (ULN) | 0 Participants |
| Placebo/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Phosphorus (mmol/L): >1.1×ULN | 2 Participants |
| Placebo/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Neutrophils Absolute Cell Count (10^9/L): <0.8×LLN | 0 Participants |
| Placebo/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Mean Corpuscular Volume [femtoliter(fL)]: >1.1×ULN | 0 Participants |
| Placebo/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Hematocrit (RATIO): >1.1×ULN | 0 Participants |
| Placebo/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Uric Acid (Urate) (μmol/L): >1.1×ULN | 4 Participants |
| Placebo/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Bicarbonate (HCO3) (mmol/L): <0.9×LLN | 1 Participants |
| Placebo/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Blood Urea Nitrogen (mmol/L): >1.2×ULN | 2 Participants |
| Placebo/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Protein, Total (g/L): <0.9×LLN | 0 Participants |
| Placebo/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Calcium (mmol/L): >1.1×ULN | 0 Participants |
| Placebo/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Bicarbonate (HCO3) [millimoles (mmol)/L]: >1.1×ULN | 0 Participants |
| Placebo/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Calcium (mmol/L): <0.9×LLN | 0 Participants |
| Placebo/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Aspartate Aminotransferase [Serum Glutamic Oxaloacetic Transaminase (SGOT)] (U/L): >=3×ULN | 0 Participants |
| Placebo/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Neutrophils Absolute Cell Count (10^9/L): >1.5×ULN | 0 Participants |
| Placebo/Relamorelin | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Chloride (mmol/L): <0.9×LLN | 0 Participants |