Diabetes Mellitus, Gastroparesis
Conditions
Keywords
diabetic gastroparesis, vomiting
Brief summary
A 52-week study to compare the efficacy of relamorelin with that of placebo in participants with diabetic gastroparesis (DG) with respect to the core signs and symptoms of diabetic gastroparesis.
Interventions
DRUGPlacebo
Placebo injected subcutaneously twice daily.
DRUGRelamorelin
Relamorelin 10 μg injected subcutaneously twice daily.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Two different groups of participants may enter into the study: 1. Rollover Participants Participants who were not randomization-eligible at the end of the Run-in Period of lead-in studies RLM-MD-01 (NCT03285308) or RLM-MD-02 (NCT03426345) are eligible to be randomized in the study if all of the following criteria apply: •In the lead-in studies, participants must have met all screening visit and Run-in Period criteria for randomization into the Treatment Period (including compliance with dosing, entry of diary data into the Diabetic Gastroparesis Symptom Severity Diary (DGSSD)) except that: * They had zero vomiting episodes and an average daily Diabetic Gastroparesis Symptom Severity Score (DGSSS) of ≥12 at the end of the lead-in study Run-in Period, as reported using the electronic hand-held device; OR * They had vomiting episodes and an average daily DGSSS of ≥12 but \<16 at the end of the lead-in study Run-in Period, as reported using the electronic hand-held device 2. De Novo Participants * Type 1 Diabetes Mellitus (T1DM) or Type 2 Diabetes Mellitus (T2DM) of at least 5 years' duration, with controlled and stable blood glucose levels and hemoglobin A1c (HBA1c) ≤11% * DG defined as at least a 3-month history prior to Screening of symptoms (one of which must be nausea) on an ongoing basis that are suggestive of gastroparesis (GP) (e.g., nausea, abdominal pain, postprandial fullness, bloating, vomiting, and early satiety) * Compliance with the entry of data into the hand-held electronic device during the Run-in Period * Compliance with administration of subcutaneous (SC) twice daily injections during the Run-in Period * The average of the daily DGSSS from the 2-week, Run-in Period must be ≥12
Exclusion criteria
1. Both Rollover and De Novo Participants •Participants with a known allergy or hypersensitivity to the study treatments and their excipients (i.e., mannitol or phenol) 2. Rollover Participants •Participants will be excluded from this study if any of the lead-in study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS) | Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02 for rollover participants or Day -14 to Day -1 for new participants) to Week 12 of this study | Participants assessed the severity of diabetic gastroparesis symptoms daily using the Diabetic Gastroparesis Symptom Severity Diary (DGSSD), recorded in an electronic diary (e-diary). The DGSSS was derived as the sum of the weekly averages of the 4 DGSSD items: nausea, abdominal pain, postprandial fullness and bloating. Each symptom was scored using an 11-point ordinal scale where: 0=no or not at all uncomfortable to 10=worst possible or most uncomfortable for a total possible DGSSS of 0 (best) to 40 (worst). A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period of the previous study or the run-in period of this study for new participants. |
| Change From Baseline to Week 52 in the Weekly Average DGSSS | Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02 for rollover participants or Day -14 to Day -1 for new participants) to Week 52 of this study | Participants assessed the severity of diabetic gastroparesis symptoms daily using the DGSSD, recorded in an electronic diary (e-diary). The DGSSS was derived as the sum of the weekly averages of the 4 DGSSD items: nausea, abdominal pain, postprandial fullness and bloating. Each symptom was scored using an 11-point ordinal scale where: 0=no or not at all uncomfortable to 10=worst possible or most uncomfortable for a total possible DGSSS of 0 (best) to 40 (worst). The average weekly scores at Week 52 were the average of the DGSSS scores from Week 49 to Week 52. A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period of the previous study or the run-in period of this study for new participants. |
| Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAE) | First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 56 weeks) | 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 | Up to 52 weeks | 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 participant 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 52 weeks | 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 Significant Abnormal Electrocardiogram (ECG) Results | Up to 52 weeks | A standard 12-lead ECG was performed. The investigator determined if the abnormal results were clinically significant. |
| Number of Participants With a ≥1% Increase in Glycosylated Hemoglobin A1c (HbA1c) | Up to 52 weeks | — |
| Number of Participants With Anti-relamorelin Antibody Testing Results by Visit | Baseline (Day 1), Day 84, Day 364, and End of Treatment (Up to Day 364) | A blood sample was collected that was sent to a laboratory for an anti-relamorelin antibody screening test. A positive screening test was confirmed by an immunodepletion assay. The number of participants in each of the following categories are reported: Negative Screening Test, Positive Screening Test, Negative Confirmatory Test, and Positive Confirmatory Test at each time point. |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Colombia, Denmark, Germany, Hungary, India, Israel, Latvia, Malaysia, Mexico, Philippines, Poland, Russia, Singapore, South Africa, South Korea, Spain, Thailand, Ukraine, United Kingdom, United States
Participant flow
Pre-assignment details
Participants who completed the placebo run-in of relamorelin studies: RLM-MD-01 \[NCT03285308\] and RLM-MD-02 \[NCT03426345\] were eligible to rollover to this study. De novo (New) participants, who had not participated in the previous studies, were also eligible for enrollment.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in. | 148 |
| Relamorelin 10 μg Relamorelin 10 μg injected subcutaneously twice daily for up to 52 weeks. De novo (New) participants, who did not participate in the previous relamorelin studies, began the study with a 2-week placebo run-in. | 302 |
| Total | 450 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 6 | 18 |
| Overall Study | Death | 0 | 2 |
| Overall Study | Lack of Efficacy | 0 | 3 |
| Overall Study | Lost to Follow-up | 5 | 15 |
| Overall Study | Physician Decision | 0 | 1 |
| Overall Study | Protocol Deviation | 1 | 8 |
| Overall Study | Reason not Specified | 4 | 6 |
| Overall Study | Screen Failure | 1 | 0 |
| Overall Study | Study Terminated by the Sponsor | 48 | 95 |
| Overall Study | Withdrawal by Subject | 20 | 36 |
Baseline characteristics
| Characteristic | Relamorelin 10 μg | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 57.9 years STANDARD_DEVIATION 11.57 | 57.6 years STANDARD_DEVIATION 11.84 | 57.0 years STANDARD_DEVIATION 12.37 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 82 Participants | 132 Participants | 50 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 220 Participants | 318 Participants | 98 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 11 Participants | 18 Participants | 7 Participants |
| Race (NIH/OMB) Asian | 9 Participants | 9 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 53 Participants | 80 Participants | 27 Participants |
| Race (NIH/OMB) More than one race | 11 Participants | 15 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 218 Participants | 327 Participants | 109 Participants |
| Sex: Female, Male Female | 224 Participants | 326 Participants | 102 Participants |
| Sex: Female, Male Male | 78 Participants | 124 Participants | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 148 | 2 / 302 |
| other Total, other adverse events | 37 / 145 | 82 / 299 |
| serious Total, serious adverse events | 21 / 145 | 43 / 299 |
Outcome results
Primary
Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS)
Participants assessed the severity of diabetic gastroparesis symptoms daily using the Diabetic Gastroparesis Symptom Severity Diary (DGSSD), recorded in an electronic diary (e-diary). The DGSSS was derived as the sum of the weekly averages of the 4 DGSSD items: nausea, abdominal pain, postprandial fullness and bloating. Each symptom was scored using an 11-point ordinal scale where: 0=no or not at all uncomfortable to 10=worst possible or most uncomfortable for a total possible DGSSS of 0 (best) to 40 (worst). A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period of the previous study or the run-in period of this study for new participants.
Time frame: Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02 for rollover participants or Day -14 to Day -1 for new participants) to Week 12 of this study
Population: Modified-intent-to-treat (mITT) Population included all randomized participants with ≥1 postbaseline assessment of DGSSD. Number analyzed is the number of participants with data available for analysis at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS) | Baseline | 20.3 score on a scale | Standard Deviation 6.7 |
| Placebo | Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS) | Change from Baseline to Week 12 | -7.1 score on a scale | Standard Deviation 8.82 |
| Relamorelin 10 μg | Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS) | Baseline | 19.7 score on a scale | Standard Deviation 6.39 |
| Relamorelin 10 μg | Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS) | Change from Baseline to Week 12 | -6.5 score on a scale | Standard Deviation 7.8 |
Primary
Change From Baseline to Week 52 in the Weekly Average DGSSS
Participants assessed the severity of diabetic gastroparesis symptoms daily using the DGSSD, recorded in an electronic diary (e-diary). The DGSSS was derived as the sum of the weekly averages of the 4 DGSSD items: nausea, abdominal pain, postprandial fullness and bloating. Each symptom was scored using an 11-point ordinal scale where: 0=no or not at all uncomfortable to 10=worst possible or most uncomfortable for a total possible DGSSS of 0 (best) to 40 (worst). The average weekly scores at Week 52 were the average of the DGSSS scores from Week 49 to Week 52. A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period of the previous study or the run-in period of this study for new participants.
Time frame: Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02 for rollover participants or Day -14 to Day -1 for new participants) to Week 52 of this study
Population: mITT Population included all randomized participants with ≥1 postbaseline assessment of DGSSD. Number analyzed is the number of participants with data available for analysis at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Week 52 in the Weekly Average DGSSS | Baseline | 20.3 score on a scale | Standard Deviation 6.7 |
| Placebo | Change From Baseline to Week 52 in the Weekly Average DGSSS | Change from Baseline to Week 52 | -10.7 score on a scale | Standard Deviation 8.93 |
| Relamorelin 10 μg | Change From Baseline to Week 52 in the Weekly Average DGSSS | Baseline | 19.7 score on a scale | Standard Deviation 6.39 |
| Relamorelin 10 μg | Change From Baseline to Week 52 in the Weekly Average DGSSS | Change from Baseline to Week 52 | -8.6 score on a scale | Standard Deviation 8.92 |
Primary
Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAE)
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: First dose of study drug to within 30 days of the last dose of study drug (Up to approximately 56 weeks)
Population: Safety Population included all participants who received ≥1 administration of study treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAE) | 105 Participants |
| Relamorelin 10 μg | Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAE) | 221 Participants |
Primary
Number of Participants With a ≥1% Increase in Glycosylated Hemoglobin A1c (HbA1c)
Time frame: Up to 52 weeks
Population: Safety Population included all participants who received ≥1 administration of study treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With a ≥1% Increase in Glycosylated Hemoglobin A1c (HbA1c) | 94 Participants |
| Relamorelin 10 μg | Number of Participants With a ≥1% Increase in Glycosylated Hemoglobin A1c (HbA1c) | 246 Participants |
Primary
Number of Participants With Anti-relamorelin Antibody Testing Results by Visit
A blood sample was collected that was sent to a laboratory for an anti-relamorelin antibody screening test. A positive screening test was confirmed by an immunodepletion assay. The number of participants in each of the following categories are reported: Negative Screening Test, Positive Screening Test, Negative Confirmatory Test, and Positive Confirmatory Test at each time point.
Time frame: Baseline (Day 1), Day 84, Day 364, and End of Treatment (Up to Day 364)
Population: Safety Population included all participants who received ≥1 administration of double-blind study treatment (N=299 in the Relamorelin 10 μg arm). Anti-relamorelin antibody testing was only done for those participants who received treatment with relamorelin. Number analyzed is the number of participants with data available at the given timepoint. Due to a laboratory issue not all positive screening tests were confirmed.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Placebo | Number of Participants With Anti-relamorelin Antibody Testing Results by Visit | Screening Test (Baseline) | Negative | 127 Participants |
| Placebo | Number of Participants With Anti-relamorelin Antibody Testing Results by Visit | Screening Test (End of Treatment) | Negative | 20 Participants |
| Placebo | Number of Participants With Anti-relamorelin Antibody Testing Results by Visit | Screening Test (Baseline) | Positive | 39 Participants |
| Placebo | Number of Participants With Anti-relamorelin Antibody Testing Results by Visit | Confirmatory Test (Baseline) | Negative | 5 Participants |
| Placebo | Number of Participants With Anti-relamorelin Antibody Testing Results by Visit | Confirmatory Test (Baseline) | Positive | 0 Participants |
| Placebo | Number of Participants With Anti-relamorelin Antibody Testing Results by Visit | Screening Test (Day 84) | Negative | 73 Participants |
| Placebo | Number of Participants With Anti-relamorelin Antibody Testing Results by Visit | Screening Test (Day 84) | Positive | 23 Participants |
| Placebo | Number of Participants With Anti-relamorelin Antibody Testing Results by Visit | Confirmatory Test (Day 84) | Negative | 6 Participants |
| Placebo | Number of Participants With Anti-relamorelin Antibody Testing Results by Visit | Confirmatory Test (Day 84) | Positive | 1 Participants |
| Placebo | Number of Participants With Anti-relamorelin Antibody Testing Results by Visit | Screening Test (Day 364) | Negative | 10 Participants |
| Placebo | Number of Participants With Anti-relamorelin Antibody Testing Results by Visit | Screening Test (Day 364) | Positive | 4 Participants |
| Placebo | Number of Participants With Anti-relamorelin Antibody Testing Results by Visit | Screening Test (End of Treatment) | Positive | 6 Participants |
| Placebo | Number of Participants With Anti-relamorelin Antibody Testing Results by Visit | Confirmatory Test (End of Treatment) | Negative | 1 Participants |
| Placebo | Number of Participants With Anti-relamorelin Antibody Testing Results by Visit | Confirmatory Test (End of Treatment) | Positive | 0 Participants |
| Placebo | Number of Participants With Anti-relamorelin Antibody Testing Results by Visit | Screening Test (Unscheduled) | Negative | 2 Participants |
| Placebo | Number of Participants With Anti-relamorelin Antibody Testing Results by Visit | Screening Test (Unscheduled) | Positive | 1 Participants |
| Placebo | Number of Participants With Anti-relamorelin Antibody Testing Results by Visit | Confirmatory Test (Unscheduled) | Negative | 1 Participants |
| Placebo | Number of Participants With Anti-relamorelin Antibody Testing Results by Visit | Confirmatory Test (Unscheduled) | Positive | 0 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 52 weeks
Population: Safety Population included all participants who received ≥1 administration of study treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Clinically Meaningful Trends for Vital Signs | 0 Participants |
| Relamorelin 10 μg | Number of Participants With Clinically Meaningful Trends for Vital Signs | 0 Participants |
Primary
Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Results
A standard 12-lead ECG was performed. The investigator determined if the abnormal results were clinically significant.
Time frame: Up to 52 weeks
Population: Safety Population included all participants who received ≥1 administration of study treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Results | 2 Participants |
| Relamorelin 10 μg | Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Results | 2 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 participant had a non-PCS value at Baseline and met the PCS criterion at least once during postbaseline are reported.
Time frame: Up to 52 weeks
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) |
|---|---|---|---|
| Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Red Blood Cell Count (10^12/L):<0.9×LLN | 2 Participants |
| Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Bilirubin, Total (micromole (umol)/L): >1.5×ULN | 0 Participants |
| Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Lymphocytes Absolute Cell Count (10^9/L): <0.8×LLN | 2 Participants |
| Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Blood Urea Nitrogen (mmol/L): >1.2×ULN | 14 Participants |
| Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | White Blood Cell Count (10^9/L): <0.7×LLN | 2 Participants |
| Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Calcium (mmol/L): >1.1×ULN | 0 Participants |
| Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Hemoglobin (gram(g)/L): <0.9×LLN | 10 Participants |
| Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Chloride (mmol/L): <0.9×LLN | 1 Participants |
| Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Hematocrit (RATIO): <0.9×Lower Limit of Normal Value (LLN) | 5 Participants |
| Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Cholesterol, Total, Fasting (mmol/L): >1.6×ULN | 2 Participants |
| Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Alanine Aminotransferase (Serum Glutamate-Pyruvate transaminase (SGPT)) (Unit (U)/L): ≥3.0×ULN | 0 Participants |
| Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Creatinine (umol/L): >1.3×ULN | 15 Participants |
| Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Mean Corpuscular Volume [femtoliter(fL)]: >1.1×ULN | 2 Participants |
| Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Glucose-Chemistry, Fasting (mmol/L): >2.5×ULN | 22 Participants |
| Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Albumin (gram (g)/L): <0.9×LLN | 0 Participants |
| Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Glucose-Chemistry, Fasting (mmol/L): <0.9×LLN | 4 Participants |
| Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Triglycerides, Fasting (mmol/L): ≥3.0×ULN | 8 Participants |
| Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Glycohemoglobin A1C (%): Increase of ≥0.5% | 95 Participants |
| Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Alkaline Phosphatase (U/L): ≥3.0×ULN | 0 Participants |
| Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Glycohemoglobin A1C (%): Increase of ≥1% | 94 Participants |
| Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Neutrophils Absolute Cell Count (10^9/L): >1.5×ULN | 2 Participants |
| Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Phosphorus (mmol/L): >1.1×ULN | 13 Participants |
| Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Aspartate Aminotransferase (Serum Glutamic-Oxaloacetic Transaminase (SGOT)) (U/L): ≥3.0×ULN | 2 Participants |
| Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Phosphorus (mmol/L): <0.9×LLN | 1 Participants |
| Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Lymphocytes Absolute Cell Count (10^9/(Liter(L)): >1.5×ULN | 1 Participants |
| Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Potassium (mmol/L): <0.9×LLN | 1 Participants |
| Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Bicarbonate (HCO3) (millimole (mmol)/L): >1.1×ULN | 3 Participants |
| Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Protein, Total (g)/L): >1.1×ULN | 1 Participants |
| Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Neutrophils Absolute Cell Count (10^9/L): <0.8×LLN | 7 Participants |
| Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Bicarbonate (HCO3) (millimole (mmol)/L): >1.1×LLN | 3 Participants |
| Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Uric Acid (Urate) (umol/L): >1.1×ULN | 17 Participants |
| Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Hematocrit (RATIO): >1.1×Upper Limit of Normal Value (ULN) | 0 Participants |
| Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Uric Acid (Urate) (umol/L): <0.9×LLN | 1 Participants |
| Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Bicarbonate (HCO3) (millimole (mmol)/L): <0.9×LLN | 6 Participants |
| Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Chloride (mmol/L): <0.9×LLN | 1 Participants |
| Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Hematocrit (RATIO): >1.1×Upper Limit of Normal Value (ULN) | 1 Participants |
| Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Hematocrit (RATIO): <0.9×Lower Limit of Normal Value (LLN) | 14 Participants |
| Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Hemoglobin (gram(g)/L): <0.9×LLN | 20 Participants |
| Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Lymphocytes Absolute Cell Count (10^9/(Liter(L)): >1.5×ULN | 5 Participants |
| Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Lymphocytes Absolute Cell Count (10^9/L): <0.8×LLN | 9 Participants |
| Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Mean Corpuscular Volume [femtoliter(fL)]: >1.1×ULN | 2 Participants |
| Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Neutrophils Absolute Cell Count (10^9/L): >1.5×ULN | 0 Participants |
| Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Neutrophils Absolute Cell Count (10^9/L): <0.8×LLN | 3 Participants |
| Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Red Blood Cell Count (10^12/L):<0.9×LLN | 10 Participants |
| Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | White Blood Cell Count (10^9/L): <0.7×LLN | 0 Participants |
| Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Alanine Aminotransferase (Serum Glutamate-Pyruvate transaminase (SGPT)) (Unit (U)/L): ≥3.0×ULN | 6 Participants |
| Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Albumin (gram (g)/L): <0.9×LLN | 1 Participants |
| Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Alkaline Phosphatase (U/L): ≥3.0×ULN | 1 Participants |
| Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Aspartate Aminotransferase (Serum Glutamic-Oxaloacetic Transaminase (SGOT)) (U/L): ≥3.0×ULN | 3 Participants |
| Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Bicarbonate (HCO3) (millimole (mmol)/L): >1.1×ULN | 2 Participants |
| Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Bicarbonate (HCO3) (millimole (mmol)/L): >1.1×LLN | 2 Participants |
| Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Bicarbonate (HCO3) (millimole (mmol)/L): <0.9×LLN | 6 Participants |
| Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Bilirubin, Total (micromole (umol)/L): >1.5×ULN | 1 Participants |
| Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Blood Urea Nitrogen (mmol/L): >1.2×ULN | 27 Participants |
| Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Calcium (mmol/L): >1.1×ULN | 1 Participants |
| Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Cholesterol, Total, Fasting (mmol/L): >1.6×ULN | 5 Participants |
| Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Creatinine (umol/L): >1.3×ULN | 20 Participants |
| Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Glucose-Chemistry, Fasting (mmol/L): >2.5×ULN | 52 Participants |
| Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Glucose-Chemistry, Fasting (mmol/L): <0.9×LLN | 14 Participants |
| Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Glycohemoglobin A1C (%): Increase of ≥0.5% | 247 Participants |
| Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Glycohemoglobin A1C (%): Increase of ≥1% | 246 Participants |
| Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Phosphorus (mmol/L): >1.1×ULN | 5 Participants |
| Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Phosphorus (mmol/L): <0.9×LLN | 4 Participants |
| Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Potassium (mmol/L): <0.9×LLN | 0 Participants |
| Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Protein, Total (g)/L): >1.1×ULN | 0 Participants |
| Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Triglycerides, Fasting (mmol/L): ≥3.0×ULN | 9 Participants |
| Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Uric Acid (Urate) (umol/L): >1.1×ULN | 37 Participants |
| Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Uric Acid (Urate) (umol/L): <0.9×LLN | 9 Participants |