Diabetes Mellitus, Gastroparesis
Conditions
Keywords
diabetic gastroparesis, vomiting
Brief summary
A 46-week study to compare the efficacy of relamorelin with that of placebo in participants with diabetic gastroparesis (DG). At the end of the 40-week Treatment Period, participants will either continue on relamorelin or placebo for 6 additional weeks.
Interventions
DRUGPlacebo
Placebo injected twice daily
DRUGRelamorelin
Relamorelin 10 μg injected 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
* Participants are eligible to be included in the study only if all the following criteria apply: * Participant met all inclusion/
Exclusion criteria
of either Protocol RLM-MD-01 (NCT03285308) or Protocol RLM-MD-02 (NCT03426345) and successfully completed the study * Able to provide written informed consent (IC) prior to any study procedures and willing and able to comply with study procedures * In the opinion of the investigator, the participant demonstrated adequate compliance with the study procedures in Study RLM-MD-01 or RLM-MD-02
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS) of the Treatment Period | Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) 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 in the previous studies. |
| Percentage of Participants Meeting the Vomiting Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period | Week 6 to Week 12 | The number of vomiting episodes in the previous 24 hours were assessed daily by the participant using the DGSSD and were recorded in the e-diary. A Vomiting Responder was defined as a participant with zero weekly vomiting episodes during each of the last 6 weeks of the first 12-weeks of the 40-week Treatment Period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Meeting the Bloating Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period | Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 6 to Week 12) | A Bloating Responder was defined as a participant with an improvement (decrease) of at least 2-points in the weekly symptom scores for bloating at each of the last 6 weeks of the first 12-weeks of the 40-week Treatment Period. Bloating was one of the items of the DGSSD assessed daily and recorded by the participant in the e-diary using an 11-point ordinal scale where: 0=no bloating and 10=the worst possible bloating and was recorded in the e-diary. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies. |
| Percentage of Participants Meeting the Postprandial Fullness Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period | Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 6 to Week 12) | A Postprandial Fullness Responder was defined as a participant with an improvement (decrease) of at least 2-points in the weekly symptom scores for Postprandial Fullness at each of the last 6 weeks of the first 12-weeks of the 40-week Treatment Period. Postprandial Fullness was one of the items of the DGSSD assessed daily and recorded by the participant in the e-diary using an 11-point ordinal scale where: 0=no feeling of fullness until finishing a meal (best) to 10=feeling full after only a few bites (worst). Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies. |
| Change From Baseline to Week 40 in the Average Weekly DGSSS of the Treatment Period | Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 37 to Week 40) | Participants assessed the severity of diabetic gastroparesis symptoms daily using the DGSSD, recorded in an e-diary. The DGSSS was derived as the sum of the weekly averages (Week 37 to Week 40) 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 studies. |
| Percentage of Participants Meeting the Vomiting Responder Criterion at Week 40 of the Treatment Period | Week 37 to Week 40 | The number of vomiting episodes in the previous 24 hours were assessed daily by the participant using the DGSSD and were recorded in the e-diary. A Vomiting Responder was defined as a participant with zero weekly vomiting episodes during the last 4 weeks of the 40-week Treatment Period. |
| Change From Baseline to Week 40 in the Average Weekly Number of Vomiting Episodes of the Treatment Period | Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 37 to Week 40) | The number of vomiting episodes in the previous 24 hours were assessed daily by the participant using the DGSSD and were recorded in the e-diary. The average weekly number of vomiting episodes were derived as the average of the weekly number of vomiting episodes in the last 4 weeks of the 40-week Treatment Period. A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies. |
| Change From Baseline to Week 46 in the Average Weekly DGSSS of the Randomized-Withdrawal Period | Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 41 to Week 46) | Participants assessed the severity of diabetic gastroparesis symptoms daily using the DGSSD, recorded in an 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). Average weekly scores are derived as the average of the weekly scores from the 6 weeks of the RW Period. A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies. |
| Percentage of Participants Meeting the Nausea Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period | Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 6 to Week 12) | A Nausea Responder was defined as a participant with improvement (decrease) of at least 2-points in the weekly symptom scores for nausea at each of the last 6 weeks of the first 12-weeks of the 40-week Treatment Period. Nausea was one of the items of the DGSSD assessed daily and recorded in the e-diary by the participant using an 11-point ordinal scale where: 0=no nausea to 10=worst possible nausea. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies. |
| 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 50 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 46 weeks | Clinical Laboratory values 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 46 weeks | Vital Signs included assessments of heart rate, respiratory rate, systolic and diastolic blood pressure, and body temperature. The investigator determined if the results were clinically significant. |
| Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Results | Up to 46 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 46 weeks | — |
| Number of Participants With Anti-relamorelin Antibody Testing Results | Up to 46 weeks | 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. |
| Change From Baseline to Week 46 in the Average Weekly Number of Vomiting Episodes of the Randomized-Withdrawal Period | Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 41 to Week 46) | The number of vomiting episodes in the previous 24 hours were assessed daily by the participant using the DGSSD and were recorded in the e-diary. Average weekly number of vomiting episodes are derived as the average of the weekly number of vomiting episodes from the six weeks of the RW Period. A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies. |
| Percentage of Participants Meeting the Abdominal Pain Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period | Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 6 to Week 12) | An Abdominal Pain Responder was defined as a participant with an improvement (decrease) of at least 2-points in the weekly symptom scores for abdominal pain at each of the last 6 weeks of the first 12-weeks of the 40-week Treatment Period. Abdominal pain was one of the items of the DGSSD assessed daily and recorded in the e-diary by the participant using an 11-point ordinal scale where: 0=no abdominal pain to 10=the worst possible abdominal pain and was recorded in an e-diary. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies. |
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, Thailand, Ukraine, United Kingdom, United States
Participant flow
Pre-assignment details
Participants who completed RLM-MD-01 \[NCT03285308\] or RLM-MD-02 \[NCT03426345\] were eligible for enrollment.
Participants by arm
| Arm | Count |
|---|---|
| Treatment Period: Placebo Placebo-matching relamorelin injected subcutaneously twice daily for up to 40 weeks. | 236 |
| Treatment Period: Relamorelin 10 μg Relamorelin 10 μg injected subcutaneously twice daily for up to 40 weeks. | 231 |
| Total | 467 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| RW Period: 6 Weeks (Week 41 to Week 46) | Adverse Event | 0 | 0 | 0 | 2 | 0 |
| RW Period: 6 Weeks (Week 41 to Week 46) | Study Terminated by the Sponsor | 0 | 0 | 6 | 3 | 3 |
| RW Period: 6 Weeks (Week 41 to Week 46) | Withdrawal by Subject | 0 | 0 | 0 | 0 | 2 |
| Treatment Period (40 Weeks) | Adverse Event | 1 | 6 | 0 | 0 | 0 |
| Treatment Period (40 Weeks) | Death | 2 | 2 | 0 | 0 | 0 |
| Treatment Period (40 Weeks) | Lack of Efficacy | 1 | 1 | 0 | 0 | 0 |
| Treatment Period (40 Weeks) | Lost to Follow-up | 10 | 6 | 0 | 0 | 0 |
| Treatment Period (40 Weeks) | Physician Decision | 3 | 4 | 0 | 0 | 0 |
| Treatment Period (40 Weeks) | Protocol Deviation | 0 | 2 | 0 | 0 | 0 |
| Treatment Period (40 Weeks) | Reason Not Specified | 3 | 0 | 0 | 0 | 0 |
| Treatment Period (40 Weeks) | Site Terminated by the Sponsor | 1 | 0 | 0 | 0 | 0 |
| Treatment Period (40 Weeks) | Study Terminated by the Sponsor | 101 | 89 | 0 | 0 | 0 |
| Treatment Period (40 Weeks) | Withdrawal by Subject | 22 | 16 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Treatment Period: Relamorelin 10 μg | Total | Treatment Period: Placebo |
|---|---|---|---|
| Age, Continuous | 56.2 years STANDARD_DEVIATION 11.51 | 55.9 years STANDARD_DEVIATION 11.3 | 55.5 years STANDARD_DEVIATION 11.11 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 82 Participants | 165 Participants | 83 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 149 Participants | 302 Participants | 153 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 8 Participants | 11 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 18 Participants | 39 Participants | 21 Participants |
| Race (NIH/OMB) Black or African American | 21 Participants | 58 Participants | 37 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 183 Participants | 358 Participants | 175 Participants |
| Sex: Female, Male Female | 166 Participants | 328 Participants | 162 Participants |
| Sex: Female, Male Male | 65 Participants | 139 Participants | 74 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 | 3 / 236 | 2 / 231 | 0 / 91 | 0 / 59 | 0 / 43 |
| other Total, other adverse events | 18 / 235 | 27 / 231 | 0 / 91 | 0 / 59 | 0 / 43 |
| serious Total, serious adverse events | 24 / 235 | 20 / 231 | 3 / 91 | 2 / 59 | 1 / 43 |
Outcome results
Primary
Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS) of the Treatment Period
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 in the previous studies.
Time frame: Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to Week 12 of this study
Population: Modified-intent-to-treat (mITT) Population included all participants in the ITT population 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 |
|---|---|---|---|---|
| Treatment Period: Placebo | Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS) of the Treatment Period | Baseline | 24.9 score on a scale | Standard Deviation 5.65 |
| Treatment Period: Placebo | Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS) of the Treatment Period | Change from Baseline to Week 12 | -11.9 score on a scale | Standard Deviation 9.43 |
| Treatment Period: Relamorelin 10 μg | Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS) of the Treatment Period | Baseline | 24.8 score on a scale | Standard Deviation 6.28 |
| Treatment Period: Relamorelin 10 μg | Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS) of the Treatment Period | Change from Baseline to Week 12 | -11.2 score on a scale | Standard Deviation 9 |
Primary
Percentage of Participants Meeting the Vomiting Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period
The number of vomiting episodes in the previous 24 hours were assessed daily by the participant using the DGSSD and were recorded in the e-diary. A Vomiting Responder was defined as a participant with zero weekly vomiting episodes during each of the last 6 weeks of the first 12-weeks of the 40-week Treatment Period.
Time frame: Week 6 to Week 12
Population: mITT Population included all participants in the ITT population with ≥1 postbaseline assessment of DGSSD.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment Period: Placebo | Percentage of Participants Meeting the Vomiting Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period | 29.4 percentage of participants |
| Treatment Period: Relamorelin 10 μg | Percentage of Participants Meeting the Vomiting Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period | 21.4 percentage of participants |
Secondary
Change From Baseline to Week 40 in the Average Weekly DGSSS of the Treatment Period
Participants assessed the severity of diabetic gastroparesis symptoms daily using the DGSSD, recorded in an e-diary. The DGSSS was derived as the sum of the weekly averages (Week 37 to Week 40) 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 studies.
Time frame: Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 37 to Week 40)
Population: mITT Population included all participants in the ITT population 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 |
|---|---|---|---|---|
| Treatment Period: Placebo | Change From Baseline to Week 40 in the Average Weekly DGSSS of the Treatment Period | Baseline | 24.9 score on a scale | Standard Deviation 5.65 |
| Treatment Period: Placebo | Change From Baseline to Week 40 in the Average Weekly DGSSS of the Treatment Period | Change from Baseline to Week 40 | -13.3 score on a scale | Standard Deviation 10.22 |
| Treatment Period: Relamorelin 10 μg | Change From Baseline to Week 40 in the Average Weekly DGSSS of the Treatment Period | Baseline | 24.8 score on a scale | Standard Deviation 6.28 |
| Treatment Period: Relamorelin 10 μg | Change From Baseline to Week 40 in the Average Weekly DGSSS of the Treatment Period | Change from Baseline to Week 40 | -12.3 score on a scale | Standard Deviation 9.2 |
Secondary
Change From Baseline to Week 40 in the Average Weekly Number of Vomiting Episodes of the Treatment Period
The number of vomiting episodes in the previous 24 hours were assessed daily by the participant using the DGSSD and were recorded in the e-diary. The average weekly number of vomiting episodes were derived as the average of the weekly number of vomiting episodes in the last 4 weeks of the 40-week Treatment Period. A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies.
Time frame: Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 37 to Week 40)
Population: mITT Population included all participants in the ITT population 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 |
|---|---|---|---|---|
| Treatment Period: Placebo | Change From Baseline to Week 40 in the Average Weekly Number of Vomiting Episodes of the Treatment Period | Baseline | 6.8 vomiting episodes per week | Standard Deviation 11.09 |
| Treatment Period: Placebo | Change From Baseline to Week 40 in the Average Weekly Number of Vomiting Episodes of the Treatment Period | Change from Baseline to Week 40 | -1.8 vomiting episodes per week | Standard Deviation 17.51 |
| Treatment Period: Relamorelin 10 μg | Change From Baseline to Week 40 in the Average Weekly Number of Vomiting Episodes of the Treatment Period | Baseline | 7.3 vomiting episodes per week | Standard Deviation 11.52 |
| Treatment Period: Relamorelin 10 μg | Change From Baseline to Week 40 in the Average Weekly Number of Vomiting Episodes of the Treatment Period | Change from Baseline to Week 40 | -5.4 vomiting episodes per week | Standard Deviation 11.87 |
Secondary
Change From Baseline to Week 46 in the Average Weekly DGSSS of the Randomized-Withdrawal Period
Participants assessed the severity of diabetic gastroparesis symptoms daily using the DGSSD, recorded in an 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). Average weekly scores are derived as the average of the weekly scores from the 6 weeks of the RW Period. A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies.
Time frame: Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 41 to Week 46)
Population: RW Population included all participants who were re-randomized or assigned to a treatment of RW Period and received ≥1 administration of study treatment during the RW Period. Overall number analyzed are the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analysis at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Period: Placebo | Change From Baseline to Week 46 in the Average Weekly DGSSS of the Randomized-Withdrawal Period | Baseline | 25.7 score on a scale | Standard Deviation 5.65 |
| Treatment Period: Placebo | Change From Baseline to Week 46 in the Average Weekly DGSSS of the Randomized-Withdrawal Period | Change from Baseline to Week 46 | -13.4 score on a scale | Standard Deviation 10.45 |
| Treatment Period: Relamorelin 10 μg | Change From Baseline to Week 46 in the Average Weekly DGSSS of the Randomized-Withdrawal Period | Baseline | 25.7 score on a scale | Standard Deviation 6.25 |
| Treatment Period: Relamorelin 10 μg | Change From Baseline to Week 46 in the Average Weekly DGSSS of the Randomized-Withdrawal Period | Change from Baseline to Week 46 | -12.5 score on a scale | Standard Deviation 9.71 |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Change From Baseline to Week 46 in the Average Weekly DGSSS of the Randomized-Withdrawal Period | Baseline | 24.4 score on a scale | Standard Deviation 5.47 |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Change From Baseline to Week 46 in the Average Weekly DGSSS of the Randomized-Withdrawal Period | Change from Baseline to Week 46 | -12.5 score on a scale | Standard Deviation 9.35 |
Secondary
Change From Baseline to Week 46 in the Average Weekly Number of Vomiting Episodes of the Randomized-Withdrawal Period
The number of vomiting episodes in the previous 24 hours were assessed daily by the participant using the DGSSD and were recorded in the e-diary. Average weekly number of vomiting episodes are derived as the average of the weekly number of vomiting episodes from the six weeks of the RW Period. A negative change from Baseline indicates improvement. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies.
Time frame: Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 41 to Week 46)
Population: RW Population included all participants who were re-randomized or assigned to a treatment of RW Period and received ≥1 administration of study treatment during the RW Period. Overall number analyzed are the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis at the given timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment Period: Placebo | Change From Baseline to Week 46 in the Average Weekly Number of Vomiting Episodes of the Randomized-Withdrawal Period | Baseline | 6.1 vomiting episodes per week | Standard Deviation 7.01 |
| Treatment Period: Placebo | Change From Baseline to Week 46 in the Average Weekly Number of Vomiting Episodes of the Randomized-Withdrawal Period | Change from Baseline to Week 46 | -1.8 vomiting episodes per week | Standard Deviation 18.4 |
| Treatment Period: Relamorelin 10 μg | Change From Baseline to Week 46 in the Average Weekly Number of Vomiting Episodes of the Randomized-Withdrawal Period | Baseline | 9.9 vomiting episodes per week | Standard Deviation 11.92 |
| Treatment Period: Relamorelin 10 μg | Change From Baseline to Week 46 in the Average Weekly Number of Vomiting Episodes of the Randomized-Withdrawal Period | Change from Baseline to Week 46 | -7.3 vomiting episodes per week | Standard Deviation 10.23 |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Change From Baseline to Week 46 in the Average Weekly Number of Vomiting Episodes of the Randomized-Withdrawal Period | Baseline | 4.2 vomiting episodes per week | Standard Deviation 4.73 |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Change From Baseline to Week 46 in the Average Weekly Number of Vomiting Episodes of the Randomized-Withdrawal Period | Change from Baseline to Week 46 | -1.8 vomiting episodes per week | Standard Deviation 6.12 |
Secondary
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 50 weeks)
Population: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period. RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Period: Placebo | Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAE) | 129 Participants |
| Treatment Period: Relamorelin 10 μg | Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAE) | 131 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAE) | 18 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg | Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAE) | 12 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAE) | 8 Participants |
Secondary
Number of Participants With a ≥1% Increase in Glycosylated Hemoglobin A1c (HBA1c)
Time frame: Up to 46 weeks
Population: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period. RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period. Overall number analyzed is the number of participants with non-PCS Baseline values and at least one postbaseline assessment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Period: Placebo | Number of Participants With a ≥1% Increase in Glycosylated Hemoglobin A1c (HBA1c) | 134 Participants |
| Treatment Period: Relamorelin 10 μg | Number of Participants With a ≥1% Increase in Glycosylated Hemoglobin A1c (HBA1c) | 138 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With a ≥1% Increase in Glycosylated Hemoglobin A1c (HBA1c) | 62 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg | Number of Participants With a ≥1% Increase in Glycosylated Hemoglobin A1c (HBA1c) | 26 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With a ≥1% Increase in Glycosylated Hemoglobin A1c (HBA1c) | 28 Participants |
Secondary
Number of Participants With Anti-relamorelin Antibody Testing Results
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.
Time frame: Up to 46 weeks
Population: Due to limitations at the vendor's end, the final analysis data could not be obtained.
Secondary
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 results were clinically significant.
Time frame: Up to 46 weeks
Population: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period. RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Period: Placebo | Number of Participants With Clinically Meaningful Trends for Vital Signs | 0 Participants |
| Treatment Period: Relamorelin 10 μg | Number of Participants With Clinically Meaningful Trends for Vital Signs | 0 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Clinically Meaningful Trends for Vital Signs | 0 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg | Number of Participants With Clinically Meaningful Trends for Vital Signs | 0 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Clinically Meaningful Trends for Vital Signs | 0 Participants |
Secondary
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 46 weeks
Population: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period. RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Period: Placebo | Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Results | 3 Participants |
| Treatment Period: Relamorelin 10 μg | Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Results | 2 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Results | 0 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg | Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Results | 0 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Results | 0 Participants |
Secondary
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results
Clinical Laboratory values 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: Up to 46 weeks
Population: Safety Population included all participants in the ITT population who received ≥1 administration of study treatment in Treatment Period. RW Population included all participants who were re-randomized or assigned to a treatment of RW population and received ≥1 administration of study treatment during the RW Period. Number analyzed is the number of participants with non-PCS Baseline values and at least one postbaseline assessment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment Period: Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Alkaline Phosphatase (U/L): >=3×ULN | 0 Participants |
| Treatment Period: Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Neutrophils Absolute Cell Count (10^9/L): <0.8×LLN | 6 Participants |
| Treatment Period: Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Uric Acid (Urate) (μmol/L): >1.1×ULN | 31 Participants |
| Treatment Period: Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Phosphorus (mmol/L): >1.1×ULN | 10 Participants |
| Treatment Period: Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Mean Corpuscular Volume (fL): <0.9×LLN | 4 Participants |
| Treatment Period: Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Triglycerides, Fasting (mmol/L): >=3×ULN | 9 Participants |
| Treatment Period: Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Platelet Count (Thrombocytes) (10^9/L): >1.5×ULN | 0 Participants |
| Treatment Period: Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Phosphorus (mmol/L): <0.9×LLN | 4 Participants |
| Treatment Period: Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Mean Corpuscular Volume [femtoliter (fL)]: >1.1×ULN | 2 Participants |
| Treatment Period: Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Hematocrit (RATIO): <0.9×Lower Limit of Normal Value (LLN) | 7 Participants |
| Treatment Period: Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Glycohemoglobin A1C: Increase of >=1% | 134 Participants |
| Treatment Period: Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Platelet Count (Thrombocytes) (10^9/L): <0.5×LLN | 1 Participants |
| Treatment Period: Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Blood Urea Nitrogen (mmol/L): >1.2×ULN | 29 Participants |
| Treatment Period: Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Glucose-Chemistry, Fasting (mmol/L): >2.5×ULN | 41 Participants |
| Treatment Period: Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Glycohemoglobin A1C: Increase of >=0.5% | 134 Participants |
| Treatment Period: Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Neutrophils Absolute Cell Count (10^9/L): >1.5×ULN | 0 Participants |
| Treatment Period: Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Red Blood Cell Count (10^12/L): >1.1×ULN | 1 Participants |
| Treatment Period: Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Lymphocytes Absolute Cell Count (10^9/L): <0.8×LLN | 1 Participants |
| Treatment Period: Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Bicarbonate (HCO3) (mmol)/L: >0.9×LLN | 6 Participants |
| Treatment Period: Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Hematocrit (RATIO): >1.1×ULN | 1 Participants |
| Treatment Period: Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Protein, Total (g/L): <0.9×LLN | 0 Participants |
| Treatment Period: Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Red Blood Cell Count (10^12/L): <0.9×LLN | 4 Participants |
| Treatment Period: Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Calcium (mmol/L): >1.1×ULN | 1 Participants |
| Treatment Period: Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Aspartate Aminotransferase [Serum Glutamic Oxaloacetic Transaminase (SGOT)] (U/L): >=3×ULN | 3 Participants |
| Treatment Period: Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Creatinine (μmol/L): >1.3×ULN | 22 Participants |
| Treatment Period: Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Chloride (mmol/L): <0.9×LLN | 2 Participants |
| Treatment Period: Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | White Blood Cell Count (10^9/L): <0.7×LLN | 2 Participants |
| Treatment Period: Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Potassium (mmol/L): <0.9×LLN | 0 Participants |
| Treatment Period: Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Glucose-Chemistry, Fasting (mmol/L): <0.9×LLN | 14 Participants |
| Treatment Period: Placebo | 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) | 2 Participants |
| Treatment Period: Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Alanine Aminotransferase [Serum Glutamic Pyruvic Transaminase (SGPT)] [unit(U)/L]: >=3×ULN | 2 Participants |
| Treatment Period: Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Calcium (mmol/L): <0.9×LLN | 1 Participants |
| Treatment Period: Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Bicarbonate (HCO3) [millimoles (mmol)/L]: >1.1×ULN | 3 Participants |
| Treatment Period: Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Uric Acid (Urate) (μmol/L): <0.9×LLN | 3 Participants |
| Treatment Period: Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Protein, Total (g/L): >1.1×ULN | 0 Participants |
| Treatment Period: Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Albumin (g/L): <0.9×LLN | 1 Participants |
| Treatment Period: Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Bilirubin, Total [micromoles(μmol)/L]: >1.5×ULN | 1 Participants |
| Treatment Period: Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Cholesterol, Total, Fasting (mmol/L): >1.6×ULN | 4 Participants |
| Treatment Period: Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Hemoglobin [grams (g)/L]: <0.9×LLN | 13 Participants |
| Treatment Period: Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Triglycerides, Fasting (mmol/L): >=3×ULN | 11 Participants |
| Treatment Period: Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Alkaline Phosphatase (U/L): >=3×ULN | 3 Participants |
| Treatment Period: Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Glycohemoglobin A1C: Increase of >=0.5% | 138 Participants |
| Treatment Period: Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Hemoglobin [grams (g)/L]: <0.9×LLN | 14 Participants |
| Treatment Period: Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Potassium (mmol/L): <0.9×LLN | 0 Participants |
| Treatment Period: Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Aspartate Aminotransferase [Serum Glutamic Oxaloacetic Transaminase (SGOT)] (U/L): >=3×ULN | 2 Participants |
| Treatment Period: Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Hematocrit (RATIO): >1.1×ULN | 2 Participants |
| Treatment Period: Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Bicarbonate (HCO3) [millimoles (mmol)/L]: >1.1×ULN | 2 Participants |
| Treatment Period: Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Mean Corpuscular Volume (fL): <0.9×LLN | 0 Participants |
| Treatment Period: Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Bicarbonate (HCO3) (mmol)/L: >0.9×LLN | 9 Participants |
| Treatment Period: Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Chloride (mmol/L): <0.9×LLN | 1 Participants |
| Treatment Period: Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Phosphorus (mmol/L): <0.9×LLN | 3 Participants |
| Treatment Period: Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Bilirubin, Total [micromoles(μmol)/L]: >1.5×ULN | 0 Participants |
| Treatment Period: Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Uric Acid (Urate) (μmol/L): >1.1×ULN | 31 Participants |
| Treatment Period: Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Glycohemoglobin A1C: Increase of >=1% | 138 Participants |
| Treatment Period: Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Blood Urea Nitrogen (mmol/L): >1.2×ULN | 20 Participants |
| Treatment Period: Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Neutrophils Absolute Cell Count (10^9/L): >1.5×ULN | 2 Participants |
| Treatment Period: Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Calcium (mmol/L): >1.1×ULN | 0 Participants |
| Treatment Period: Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Lymphocytes Absolute Cell Count (10^9/L): <0.8×LLN | 4 Participants |
| Treatment Period: Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Phosphorus (mmol/L): >1.1×ULN | 12 Participants |
| Treatment Period: Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Calcium (mmol/L): <0.9×LLN | 0 Participants |
| Treatment Period: Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Creatinine (μmol/L): >1.3×ULN | 16 Participants |
| Treatment Period: Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Cholesterol, Total, Fasting (mmol/L): >1.6×ULN | 1 Participants |
| Treatment Period: Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Neutrophils Absolute Cell Count (10^9/L): <0.8×LLN | 4 Participants |
| Treatment Period: Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Uric Acid (Urate) (μmol/L): <0.9×LLN | 4 Participants |
| Treatment Period: Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Platelet Count (Thrombocytes) (10^9/L): >1.5×ULN | 1 Participants |
| Treatment Period: Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Platelet Count (Thrombocytes) (10^9/L): <0.5×LLN | 0 Participants |
| Treatment Period: Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Hematocrit (RATIO): <0.9×Lower Limit of Normal Value (LLN) | 7 Participants |
| Treatment Period: Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Protein, Total (g/L): <0.9×LLN | 1 Participants |
| Treatment Period: Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Red Blood Cell Count (10^12/L): >1.1×ULN | 0 Participants |
| Treatment Period: Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Glucose-Chemistry, Fasting (mmol/L): >2.5×ULN | 33 Participants |
| Treatment Period: Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Red Blood Cell Count (10^12/L): <0.9×LLN | 8 Participants |
| Treatment Period: Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Mean Corpuscular Volume [femtoliter (fL)]: >1.1×ULN | 3 Participants |
| Treatment Period: Relamorelin 10 μg | 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 |
| Treatment Period: 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 |
| Treatment Period: Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Protein, Total (g/L): >1.1×ULN | 1 Participants |
| Treatment Period: Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Alanine Aminotransferase [Serum Glutamic Pyruvic Transaminase (SGPT)] [unit(U)/L]: >=3×ULN | 2 Participants |
| Treatment Period: Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Glucose-Chemistry, Fasting (mmol/L): <0.9×LLN | 9 Participants |
| Treatment Period: Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Albumin (g/L): <0.9×LLN | 1 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Calcium (mmol/L): <0.9×LLN | 0 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Chloride (mmol/L): <0.9×LLN | 1 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Glycohemoglobin A1C: Increase of >=1% | 62 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Cholesterol, Total, Fasting (mmol/L): >1.6×ULN | 0 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Creatinine (μmol/L): >1.3×ULN | 5 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Glucose-Chemistry, Fasting (mmol/L): >2.5×ULN | 9 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Glycohemoglobin A1C: Increase of >=0.5% | 62 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Glucose-Chemistry, Fasting (mmol/L): <0.9×LLN | 4 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Mean Corpuscular Volume [femtoliter (fL)]: >1.1×ULN | 1 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Mean Corpuscular Volume (fL): <0.9×LLN | 1 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Hematocrit (RATIO): >1.1×ULN | 2 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Triglycerides, Fasting (mmol/L): >=3×ULN | 4 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Neutrophils Absolute Cell Count (10^9/L): >1.5×ULN | 2 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | 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 |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Neutrophils Absolute Cell Count (10^9/L): <0.8×LLN | 2 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Platelet Count (Thrombocytes) (10^9/L): >1.5×ULN | 0 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Protein, Total (g/L): <0.9×LLN | 0 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Platelet Count (Thrombocytes) (10^9/L): <0.5×LLN | 0 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Red Blood Cell Count (10^12/L): >1.1×ULN | 0 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Hematocrit (RATIO): <0.9×Lower Limit of Normal Value (LLN) | 4 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Red Blood Cell Count (10^12/L): <0.9×LLN | 4 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Protein, Total (g/L): >1.1×ULN | 0 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | White Blood Cell Count (10^9/L): <0.7×LLN | 0 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | 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 |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Albumin (g/L): <0.9×LLN | 1 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Potassium (mmol/L): <0.9×LLN | 2 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Alkaline Phosphatase (U/L): >=3×ULN | 0 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Aspartate Aminotransferase [Serum Glutamic Oxaloacetic Transaminase (SGOT)] (U/L): >=3×ULN | 0 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Hemoglobin [grams (g)/L]: <0.9×LLN | 5 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Bicarbonate (HCO3) [millimoles (mmol)/L]: >1.1×ULN | 1 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Uric Acid (Urate) (μmol/L): <0.9×LLN | 1 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Phosphorus (mmol/L): <0.9×LLN | 0 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Bicarbonate (HCO3) (mmol)/L: >0.9×LLN | 2 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Bilirubin, Total [micromoles(μmol)/L]: >1.5×ULN | 0 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Uric Acid (Urate) (μmol/L): >1.1×ULN | 5 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Blood Urea Nitrogen (mmol/L): >1.2×ULN | 8 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Phosphorus (mmol/L): >1.1×ULN | 4 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Calcium (mmol/L): >1.1×ULN | 1 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Lymphocytes Absolute Cell Count (10^9/L): <0.8×LLN | 0 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Bicarbonate (HCO3) (mmol)/L: >0.9×LLN | 4 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg | 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 |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Hematocrit (RATIO): >1.1×ULN | 1 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Hematocrit (RATIO): <0.9×Lower Limit of Normal Value (LLN) | 0 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Hemoglobin [grams (g)/L]: <0.9×LLN | 1 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Lymphocytes Absolute Cell Count (10^9/L): <0.8×LLN | 0 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Mean Corpuscular Volume [femtoliter (fL)]: >1.1×ULN | 0 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Mean Corpuscular Volume (fL): <0.9×LLN | 0 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then 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 |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Neutrophils Absolute Cell Count (10^9/L): <0.8×LLN | 0 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Platelet Count (Thrombocytes) (10^9/L): >1.5×ULN | 0 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Platelet Count (Thrombocytes) (10^9/L): <0.5×LLN | 0 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Red Blood Cell Count (10^12/L): >1.1×ULN | 0 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Red Blood Cell Count (10^12/L): <0.9×LLN | 1 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Alanine Aminotransferase [Serum Glutamic Pyruvic Transaminase (SGPT)] [unit(U)/L]: >=3×ULN | 2 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Albumin (g/L): <0.9×LLN | 0 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Alkaline Phosphatase (U/L): >=3×ULN | 0 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Aspartate Aminotransferase [Serum Glutamic Oxaloacetic Transaminase (SGOT)] (U/L): >=3×ULN | 0 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Bicarbonate (HCO3) [millimoles (mmol)/L]: >1.1×ULN | 1 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Bilirubin, Total [micromoles(μmol)/L]: >1.5×ULN | 0 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Blood Urea Nitrogen (mmol/L): >1.2×ULN | 4 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Calcium (mmol/L): >1.1×ULN | 0 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Calcium (mmol/L): <0.9×LLN | 0 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Chloride (mmol/L): <0.9×LLN | 0 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Cholesterol, Total, Fasting (mmol/L): >1.6×ULN | 1 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Creatinine (μmol/L): >1.3×ULN | 2 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Glucose-Chemistry, Fasting (mmol/L): >2.5×ULN | 9 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Glucose-Chemistry, Fasting (mmol/L): <0.9×LLN | 2 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Glycohemoglobin A1C: Increase of >=0.5% | 26 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Glycohemoglobin A1C: Increase of >=1% | 26 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Phosphorus (mmol/L): >1.1×ULN | 4 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Phosphorus (mmol/L): <0.9×LLN | 0 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Potassium (mmol/L): <0.9×LLN | 0 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Protein, Total (g/L): >1.1×ULN | 0 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Protein, Total (g/L): <0.9×LLN | 0 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Triglycerides, Fasting (mmol/L): >=3×ULN | 4 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Uric Acid (Urate) (μmol/L): >1.1×ULN | 3 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Uric Acid (Urate) (μmol/L): <0.9×LLN | 0 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then 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 |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Blood Urea Nitrogen (mmol/L): >1.2×ULN | 4 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Hemoglobin [grams (g)/L]: <0.9×LLN | 4 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Phosphorus (mmol/L): >1.1×ULN | 4 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Bilirubin, Total [micromoles(μmol)/L]: >1.5×ULN | 0 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Bicarbonate (HCO3) (mmol)/L: >0.9×LLN | 1 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Bicarbonate (HCO3) [millimoles (mmol)/L]: >1.1×ULN | 0 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Uric Acid (Urate) (μmol/L): <0.9×LLN | 0 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Phosphorus (mmol/L): <0.9×LLN | 0 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Aspartate Aminotransferase [Serum Glutamic Oxaloacetic Transaminase (SGOT)] (U/L): >=3×ULN | 0 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Alkaline Phosphatase (U/L): >=3×ULN | 0 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Albumin (g/L): <0.9×LLN | 1 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Uric Acid (Urate) (μmol/L): >1.1×ULN | 1 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Potassium (mmol/L): <0.9×LLN | 0 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | 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 |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | White Blood Cell Count (10^9/L): <0.7×LLN | 0 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Red Blood Cell Count (10^12/L): <0.9×LLN | 0 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Hematocrit (RATIO): <0.9×Lower Limit of Normal Value (LLN) | 2 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Protein, Total (g/L): >1.1×ULN | 0 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Red Blood Cell Count (10^12/L): >1.1×ULN | 0 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Platelet Count (Thrombocytes) (10^9/L): <0.5×LLN | 0 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Platelet Count (Thrombocytes) (10^9/L): >1.5×ULN | 0 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Hematocrit (RATIO): >1.1×ULN | 0 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Protein, Total (g/L): <0.9×LLN | 1 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Neutrophils Absolute Cell Count (10^9/L): <0.8×LLN | 0 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Neutrophils Absolute Cell Count (10^9/L): >1.5×ULN | 0 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Mean Corpuscular Volume (fL): <0.9×LLN | 0 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | 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 |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Triglycerides, Fasting (mmol/L): >=3×ULN | 2 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Glucose-Chemistry, Fasting (mmol/L): <0.9×LLN | 2 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Glucose-Chemistry, Fasting (mmol/L): >2.5×ULN | 4 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Mean Corpuscular Volume [femtoliter (fL)]: >1.1×ULN | 0 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Glycohemoglobin A1C: Increase of >=0.5% | 28 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Creatinine (μmol/L): >1.3×ULN | 3 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Cholesterol, Total, Fasting (mmol/L): >1.6×ULN | 0 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Chloride (mmol/L): <0.9×LLN | 1 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Lymphocytes Absolute Cell Count (10^9/L): <0.8×LLN | 0 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Glycohemoglobin A1C: Increase of >=1% | 28 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Calcium (mmol/L): <0.9×LLN | 1 Participants |
| Randomized Withdrawal Period: Relamorelin 10 μg Then Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Calcium (mmol/L): >1.1×ULN | 0 Participants |
Secondary
Percentage of Participants Meeting the Abdominal Pain Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period
An Abdominal Pain Responder was defined as a participant with an improvement (decrease) of at least 2-points in the weekly symptom scores for abdominal pain at each of the last 6 weeks of the first 12-weeks of the 40-week Treatment Period. Abdominal pain was one of the items of the DGSSD assessed daily and recorded in the e-diary by the participant using an 11-point ordinal scale where: 0=no abdominal pain to 10=the worst possible abdominal pain and was recorded in an e-diary. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies.
Time frame: Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 6 to Week 12)
Population: mITT Population included all participants in the ITT population with ≥1 postbaseline assessment of DGSSD.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment Period: Placebo | Percentage of Participants Meeting the Abdominal Pain Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period | 40.4 percentage of participants |
| Treatment Period: Relamorelin 10 μg | Percentage of Participants Meeting the Abdominal Pain Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period | 39.7 percentage of participants |
Secondary
Percentage of Participants Meeting the Bloating Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period
A Bloating Responder was defined as a participant with an improvement (decrease) of at least 2-points in the weekly symptom scores for bloating at each of the last 6 weeks of the first 12-weeks of the 40-week Treatment Period. Bloating was one of the items of the DGSSD assessed daily and recorded by the participant in the e-diary using an 11-point ordinal scale where: 0=no bloating and 10=the worst possible bloating and was recorded in the e-diary. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies.
Time frame: Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 6 to Week 12)
Population: mITT Population included all participants in the ITT population with ≥1 postbaseline assessment of DGSSD.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment Period: Placebo | Percentage of Participants Meeting the Bloating Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period | 38.3 percentage of participants |
| Treatment Period: Relamorelin 10 μg | Percentage of Participants Meeting the Bloating Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period | 38.4 percentage of participants |
Secondary
Percentage of Participants Meeting the Nausea Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period
A Nausea Responder was defined as a participant with improvement (decrease) of at least 2-points in the weekly symptom scores for nausea at each of the last 6 weeks of the first 12-weeks of the 40-week Treatment Period. Nausea was one of the items of the DGSSD assessed daily and recorded in the e-diary by the participant using an 11-point ordinal scale where: 0=no nausea to 10=worst possible nausea. Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies.
Time frame: Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 6 to Week 12)
Population: mITT Population included all participants in the ITT population with ≥1 postbaseline assessment of DGSSD.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment Period: Placebo | Percentage of Participants Meeting the Nausea Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period | 46.0 percentage of participants |
| Treatment Period: Relamorelin 10 μg | Percentage of Participants Meeting the Nausea Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period | 43.2 percentage of participants |
Secondary
Percentage of Participants Meeting the Postprandial Fullness Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period
A Postprandial Fullness Responder was defined as a participant with an improvement (decrease) of at least 2-points in the weekly symptom scores for Postprandial Fullness at each of the last 6 weeks of the first 12-weeks of the 40-week Treatment Period. Postprandial Fullness was one of the items of the DGSSD assessed daily and recorded by the participant in the e-diary using an 11-point ordinal scale where: 0=no feeling of fullness until finishing a meal (best) to 10=feeling full after only a few bites (worst). Baseline was defined as the average of the 2 weekly DGSSS from the run-in period in the previous studies.
Time frame: Baseline (14-day Run-in Period of the previous relamorelin study RLM-MD-01 or RLM-MD-02) to (Week 6 to Week 12)
Population: mITT Population included all participants in the ITT population with ≥1 postbaseline assessment of DGSSD.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment Period: Placebo | Percentage of Participants Meeting the Postprandial Fullness Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period | 36.6 percentage of participants |
| Treatment Period: Relamorelin 10 μg | Percentage of Participants Meeting the Postprandial Fullness Responder Criterion During Each of the Last 6 Weeks of the First 12-weeks of the Treatment Period | 36.2 percentage of participants |
Secondary
Percentage of Participants Meeting the Vomiting Responder Criterion at Week 40 of the Treatment Period
The number of vomiting episodes in the previous 24 hours were assessed daily by the participant using the DGSSD and were recorded in the e-diary. A Vomiting Responder was defined as a participant with zero weekly vomiting episodes during the last 4 weeks of the 40-week Treatment Period.
Time frame: Week 37 to Week 40
Population: mITT Population included all participants in the ITT population with ≥1 postbaseline assessment of DGSSD.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment Period: Placebo | Percentage of Participants Meeting the Vomiting Responder Criterion at Week 40 of the Treatment Period | 19.1 percentage of participants |
| Treatment Period: Relamorelin 10 μg | Percentage of Participants Meeting the Vomiting Responder Criterion at Week 40 of the Treatment Period | 18.8 percentage of participants |