Diabetes Mellitus, Gastroparesis
Conditions
Brief summary
This study will evaluate the safety and efficacy of relamorelin compared to placebo in participants with diabetic gastroparesis. Participants will report daily severity scores of their diabetic gastroparesis symptoms.
Interventions
DRUGPlacebo
Placebo injected subcutaneously twice daily.
DRUGRelamorelin
Relamorelin 10 micrograms (μg) injected subcutaneously twice daily.
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of Type 1 or Type 2 diabetes mellitus * Meet the per protocol criteria of diabetic gastroparesis * Compliance with diary * Compliance with the per protocol study treatment dosing instructions
Exclusion criteria
* Currently receiving nutrition intravenously, by nasogastric tube, or other feeding tube * Actively experiencing anorexia nervosa, binge-eating, bulimia, or other eating disorder at the time of Screening (Visit 1) * Diagnosis of Celiac Disease, also a history of non-celiac gluten sensitivity * History of gastrointestinal disorders that may be similar to gastroparesis * Functional dyspepsia diagnosed before the diagnosis of diabetes mellitus
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS) | Baseline (Day-14 to Day-1) to Week 12 | 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. |
| Percentage of Participants Meeting the Vomiting Responder Criterion During Each of the Last 6 Weeks of the 12-week 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 12-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 12-week Treatment Period | Baseline (Day-14 to Day-1) 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 12-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. |
| Percentage of Participants Meeting the Postprandial Fullness Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period | Baseline (Day-14 to Day-1) 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 12-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). |
| Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAE) | Up to approximately 16 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 12 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 person had a non-PCS value at Baseline and met the PCS criterion at least once during postbaseline are reported. |
| Percentage of Participants Meeting the Nausea Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period | Baseline (Day-14 to Day-1) 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 12-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. |
| Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Results | Up to 12 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) | Baseline (Day 1) up to 12 weeks | HbA1c is also known as glycosylated hemoglobin. It is the concentration of glucose bound to hemoglobin as a percentage of the absolute maximum that can be bound. |
| Number of Participants With Anti-relamorelin Antibody Testing Results by Visit | Baseline (Day 1), Day 14, Day 28, Day 84, and End of Treatment (Up to Day 84) | 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. |
| Number of Participants With Clinically Meaningful Trends for Vital Signs | Up to 12 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. |
| Percentage of Participants Meeting the Abdominal Pain Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period | Baseline (Day-14 to Day-1) 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 12-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. |
Countries
Australia, Bulgaria, France, India, Israel, Malaysia, Philippines, Poland, Singapore, South Korea, Spain, Thailand, Ukraine, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks. | 167 |
| Relamorelin 10 μg Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks. | 169 |
| Total | 336 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 3 | 7 |
| Overall Study | Lost to Follow-up | 3 | 1 |
| Overall Study | Protocol Deviation | 6 | 5 |
| Overall Study | Reason not Specified | 0 | 1 |
| Overall Study | Withdrawal by Subject | 8 | 9 |
Baseline characteristics
| Characteristic | Relamorelin 10 μg | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 56.3 years STANDARD_DEVIATION 11.47 | 55.9 years STANDARD_DEVIATION 11.13 | 55.4 years STANDARD_DEVIATION 10.78 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 53 Participants | 104 Participants | 51 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 116 Participants | 232 Participants | 116 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 24 Participants | 50 Participants | 26 Participants |
| Race (NIH/OMB) Black or African American | 19 Participants | 44 Participants | 25 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 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 | 125 Participants | 241 Participants | 116 Participants |
| Sex: Female, Male Female | 115 Participants | 222 Participants | 107 Participants |
| Sex: Female, Male Male | 54 Participants | 114 Participants | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 167 | 0 / 169 |
| other Total, other adverse events | 9 / 163 | 9 / 163 |
| serious Total, serious adverse events | 15 / 163 | 16 / 163 |
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.
Time frame: Baseline (Day-14 to Day-1) to Week 12
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 at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS) | Baseline | 25.1 score on a scale | Standard Deviation 5.53 |
| Placebo | Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS) | Change from Baseline to Week 12 | -10.0 score on a scale | Standard Deviation 8.89 |
| Relamorelin 10 μg | Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS) | Baseline | 24.5 score on a scale | Standard Deviation 5.99 |
| Relamorelin 10 μg | Change From Baseline to Week 12 in the Weekly Diabetic Gastroparesis Symptom Severity Score (DGSSS) | Change from Baseline to Week 12 | -9.3 score on a scale | Standard Deviation 8.17 |
Primary
Percentage of Participants Meeting the Vomiting Responder Criterion During Each of the Last 6 Weeks of the 12-week 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 12-week Treatment Period.
Time frame: Week 6 to Week 12
Population: mITT Population included all randomized participants with ≥1 postbaseline assessment of DGSSD.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Meeting the Vomiting Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period | 19.5 percentage of participants |
| Relamorelin 10 μg | Percentage of Participants Meeting the Vomiting Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period | 21.8 percentage of participants |
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: Up to approximately 16 weeks
Population: Safety Population included all participants who received ≥1 administration of double-blind study treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAE) | 68 Participants |
| Relamorelin 10 μg | Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAE) | 70 Participants |
Secondary
Number of Participants With a ≥1% Increase in Glycosylated Hemoglobin A1c (HBA1c)
HbA1c is also known as glycosylated hemoglobin. It is the concentration of glucose bound to hemoglobin as a percentage of the absolute maximum that can be bound.
Time frame: Baseline (Day 1) up to 12 weeks
Population: Safety Population included all participants who received ≥1 administration of double-blind 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 a ≥1% Increase in Glycosylated Hemoglobin A1c (HBA1c) | Glycohemoglobin A1C: Increase of >=0.5% | 91 Participants |
| Placebo | Number of Participants With a ≥1% Increase in Glycosylated Hemoglobin A1c (HBA1c) | Glycohemoglobin A1C: Increase of >=1% | 91 Participants |
| Relamorelin 10 μg | Number of Participants With a ≥1% Increase in Glycosylated Hemoglobin A1c (HBA1c) | Glycohemoglobin A1C: Increase of >=0.5% | 125 Participants |
| Relamorelin 10 μg | Number of Participants With a ≥1% Increase in Glycosylated Hemoglobin A1c (HBA1c) | Glycohemoglobin A1C: Increase of >=1% | 124 Participants |
Secondary
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 14, Day 28, Day 84, and End of Treatment (Up to Day 84)
Population: Safety Population included all participants who received ≥ 1 administration of double-blind study treatment (N=163 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 | 133 Participants |
| Placebo | Number of Participants With Anti-relamorelin Antibody Testing Results by Visit | Screening Test (Baseline) | Positive | 16 Participants |
| Placebo | Number of Participants With Anti-relamorelin Antibody Testing Results by Visit | Confirmatory Test (Baseline) | Negative | 13 Participants |
| Placebo | Number of Participants With Anti-relamorelin Antibody Testing Results by Visit | Confirmatory Test (Baseline) | Positive | 2 Participants |
| Placebo | Number of Participants With Anti-relamorelin Antibody Testing Results by Visit | Screening Test (Day 14) | Negative | 124 Participants |
| Placebo | Number of Participants With Anti-relamorelin Antibody Testing Results by Visit | Screening Test (Day 14) | Positive | 13 Participants |
| Placebo | Number of Participants With Anti-relamorelin Antibody Testing Results by Visit | Confirmatory Test (Day 14) | Negative | 13 Participants |
| Placebo | Number of Participants With Anti-relamorelin Antibody Testing Results by Visit | Confirmatory Test (Day 14) | Positive | 0 Participants |
| Placebo | Number of Participants With Anti-relamorelin Antibody Testing Results by Visit | Screening Test (Day 28) | Negative | 115 Participants |
| Placebo | Number of Participants With Anti-relamorelin Antibody Testing Results by Visit | Screening Test (Day 28) | Positive | 16 Participants |
| Placebo | Number of Participants With Anti-relamorelin Antibody Testing Results by Visit | Confirmatory Test (Day 28) | Negative | 15 Participants |
| Placebo | Number of Participants With Anti-relamorelin Antibody Testing Results by Visit | Confirmatory Test (Day 28) | Positive | 1 Participants |
| Placebo | Number of Participants With Anti-relamorelin Antibody Testing Results by Visit | Screening Test (Day 84) | Negative | 95 Participants |
| Placebo | Number of Participants With Anti-relamorelin Antibody Testing Results by Visit | Screening Test (Day 84) | Positive | 16 Participants |
| Placebo | Number of Participants With Anti-relamorelin Antibody Testing Results by Visit | Confirmatory Test (Day 84) | Negative | 14 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 (End of Treatment) | Negative | 13 Participants |
| Placebo | Number of Participants With Anti-relamorelin Antibody Testing Results by Visit | Screening Test (End of Treatment) | Positive | 2 Participants |
| Placebo | Number of Participants With Anti-relamorelin Antibody Testing Results by Visit | Confirmatory Test (End of Treatment) | Negative | 2 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 | 2 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 | 1 Participants |
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 12 weeks
Population: Safety Population included all participants who received ≥1 administration of double-blind 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 |
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 12 weeks
Population: Safety Population included all participants who received ≥1 administration of double-blind study treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Results | 4 Participants |
| Relamorelin 10 μg | Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Results | 3 Participants |
Secondary
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results
Clinical Laboratory tests included Hematology, Chemistry and Urinalysis tests. The investigator determined if the results were clinically significant. Only those categories where at least 1 person had a non-PCS value at Baseline and met the PCS criterion at least once during postbaseline are reported.
Time frame: Up to 12 weeks
Population: Safety Population included all participants who received ≥1 administration of double-blind 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 | Hemoglobin (g/L): <0.9×LLN | 10 Participants |
| Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Blood Urea Nitrogen [millimoles(mmol/L)]: >1.2×ULN | 11 Participants |
| Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Neutrophils Absolute Cell Count (10^9/L): >1.5×ULN | 0 Participants |
| Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Calcium (mmol/L): <0.9×LLN | 0 Participants |
| Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Bicarbonate (HCO3) (mmol/L): >1.1×ULN | 3 Participants |
| Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Cholesterol, Total, Non-Fasting (mmol/L) | 0 Participants |
| Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Neutrophils Absolute Cell Count (10^9/L): <0.8×LLN | 2 Participants |
| Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Creatinine [micromoles(μmol/L)]: >1.3×ULN | 7 Participants |
| Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Lymphocytes Absolute Cell Count (10^9/L): >1.5×ULN | 1 Participants |
| Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Glucose-Chemistry, Fasting (mmol/L): >2.5×ULN | 10 Participants |
| Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Platelet Count (Thrombocytes) (10^9/L): >1.5×ULN | 0 Participants |
| Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Glucose-Chemistry, Fasting (mmol/L): <0.9×LLN | 3 Participants |
| Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Hematocrit (RATIO): <0.9×Lower Limit of Normal Value (LLN) | 2 Participants |
| Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Glycohemoglobin A1C: Increase of >=0.5% | 91 Participants |
| Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Red Blood Cell Count (10^12/L): >1.1×ULN | 0 Participants |
| Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Glycohemoglobin A1C: Increase of >=1% | 91 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 | Phosphorus (mmol/L): >1.1×ULN | 2 Participants |
| Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Red Blood Cell Count (10^12/L): <0.9×LLN | 1 Participants |
| Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Phosphorus (mmol/L): <0.9×LLN | 0 Participants |
| 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 |
| Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Triglycerides, Fasting (mmol/L): >=3×ULN | 5 Participants |
| Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | White Blood Cell Count (10^9/L): >1.5×ULN | 1 Participants |
| Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Uric Acid (Urate) (μmol/L): >1.1×ULN | 10 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 | Uric Acid (Urate) (μmol/L): <0.9×LLN | 1 Participants |
| Placebo | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Bicarbonate (HCO3) (mmol/L): >0.9×LLN | 3 Participants |
| Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Uric Acid (Urate) (μmol/L): <0.9×LLN | 3 Participants |
| 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 |
| Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Hematocrit (RATIO): <0.9×Lower Limit of Normal Value (LLN) | 2 Participants |
| Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Hemoglobin (g/L): <0.9×LLN | 4 Participants |
| Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Lymphocytes 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 | Lymphocytes Absolute Cell Count (10^9/L): <0.8×LLN | 1 Participants |
| Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Mean Corpuscular Volume [femtoliter (fL)]: >1.1×ULN | 0 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 | 1 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 | Platelet Count (Thrombocytes) (10^9/L): >1.5×ULN | 1 Participants |
| Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Red Blood Cell Count (10^12/L): >1.1×ULN | 1 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 | 1 Participants |
| Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Bicarbonate (HCO3) (mmol/L): >1.1×ULN | 1 Participants |
| Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Bicarbonate (HCO3) (mmol/L): >0.9×LLN | 1 Participants |
| Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Blood Urea Nitrogen [millimoles(mmol/L)]: >1.2×ULN | 11 Participants |
| Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Calcium (mmol/L): <0.9×LLN | 1 Participants |
| Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Cholesterol, Total, Non-Fasting (mmol/L) | 1 Participants |
| Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Creatinine [micromoles(μmol/L)]: >1.3×ULN | 8 Participants |
| Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Glucose-Chemistry, Fasting (mmol/L): >2.5×ULN | 21 Participants |
| Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Glucose-Chemistry, Fasting (mmol/L): <0.9×LLN | 1 Participants |
| Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Glycohemoglobin A1C: Increase of >=0.5% | 125 Participants |
| Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Glycohemoglobin A1C: Increase of >=1% | 124 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 | 1 Participants |
| Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Triglycerides, Fasting (mmol/L): >=3×ULN | 5 Participants |
| Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | Uric Acid (Urate) (μmol/L): >1.1×ULN | 18 Participants |
| Relamorelin 10 μg | Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results | White Blood Cell Count (10^9/L): >1.5×ULN | 1 Participants |
Secondary
Percentage of Participants Meeting the Abdominal Pain Responder Criterion During Each of the Last 6 Weeks of the 12-week 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 12-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.
Time frame: Baseline (Day-14 to Day-1) to (Week 6 to Week 12)
Population: mITT Population included all randomized participants with ≥1 postbaseline assessment of DGSSD.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Meeting the Abdominal Pain Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period | 28.0 percentage of participants |
| Relamorelin 10 μg | Percentage of Participants Meeting the Abdominal Pain Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period | 27.9 percentage of participants |
Secondary
Percentage of Participants Meeting the Bloating Responder Criterion During Each of the Last 6 Weeks of the 12-week 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 12-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.
Time frame: Baseline (Day-14 to Day-1) to (Week 6 to Week 12)
Population: mITT Population included all randomized participants with ≥1 postbaseline assessment of DGSSD.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Meeting the Bloating Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period | 26.2 percentage of participants |
| Relamorelin 10 μg | Percentage of Participants Meeting the Bloating Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period | 27.9 percentage of participants |
Secondary
Percentage of Participants Meeting the Nausea Responder Criterion During Each of the Last 6 Weeks of the 12-week 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 12-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.
Time frame: Baseline (Day-14 to Day-1) to (Week 6 to Week 12)
Population: mITT Population included all randomized participants with ≥1 postbaseline assessment of DGSSD.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Meeting the Nausea Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period | 34.1 percentage of participants |
| Relamorelin 10 μg | Percentage of Participants Meeting the Nausea Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period | 29.7 percentage of participants |
Secondary
Percentage of Participants Meeting the Postprandial Fullness Responder Criterion During Each of the Last 6 Weeks of the 12-week 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 12-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).
Time frame: Baseline (Day-14 to Day-1) to (Week 6 to Week 12)
Population: mITT Population included all randomized participants with ≥1 postbaseline assessment of DGSSD.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants Meeting the Postprandial Fullness Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period | 22.6 percentage of participants |
| Relamorelin 10 μg | Percentage of Participants Meeting the Postprandial Fullness Responder Criterion During Each of the Last 6 Weeks of the 12-week Treatment Period | 25.5 percentage of participants |