Trial Outcomes & Findings for A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis 01 (NCT NCT03285308)

NCT ID: NCT03285308

Last Updated: 2021-07-29

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 336 participants
• Primary outcome timeframe: Baseline (Day-14 to Day-1) to Week 12
• Results posted on: 2021-07-29

Participant Flow

Participant milestones

Measure	Placebo Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.	Relamorelin 10 μg Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.
Overall Study STARTED	167	169
Overall Study Safety Population	163	163
Overall Study COMPLETED	147	146
Overall Study NOT COMPLETED	20	23

Reasons for withdrawal

Measure	Placebo Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.	Relamorelin 10 μg Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.
Overall Study Adverse Event	3	7
Overall Study Withdrawal by Subject	8	9
Overall Study Lost to Follow-up	3	1
Overall Study Protocol Deviation	6	5
Overall Study Reason not Specified	0	1

Baseline Characteristics

A Safety and Efficacy Study of Relamorelin in Diabetic Gastroparesis 01

Baseline characteristics by cohort

Measure	Placebo n=167 Participants Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.	Relamorelin 10 μg n=169 Participants Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.	Total n=336 Participants Total of all reporting groups
Age, Continuous	55.4 years STANDARD_DEVIATION 10.78 • n=5 Participants	56.3 years STANDARD_DEVIATION 11.47 • n=7 Participants	55.9 years STANDARD_DEVIATION 11.13 • n=5 Participants
Sex: Female, Male Female	107 Participants n=5 Participants	115 Participants n=7 Participants	222 Participants n=5 Participants
Sex: Female, Male Male	60 Participants n=5 Participants	54 Participants n=7 Participants	114 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	51 Participants n=5 Participants	53 Participants n=7 Participants	104 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	116 Participants n=5 Participants	116 Participants n=7 Participants	232 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	26 Participants n=5 Participants	24 Participants n=7 Participants	50 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	25 Participants n=5 Participants	19 Participants n=7 Participants	44 Participants n=5 Participants
Race (NIH/OMB) White	116 Participants n=5 Participants	125 Participants n=7 Participants	241 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Placebo n=163 Participants Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.	Relamorelin 10 μg n=165 Participants Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.
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	24.5 score on a scale Standard Deviation 5.99
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	-9.3 score on a scale Standard Deviation 8.17

PRIMARY outcome

Timeframe: Week 6 to Week 12

Population: mITT Population included all randomized participants with ≥1 postbaseline assessment of DGSSD.

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.

Outcome measures

Measure	Placebo n=164 Participants Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.	Relamorelin 10 μg n=165 Participants Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.
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	21.8 percentage of participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Placebo n=164 Participants Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.	Relamorelin 10 μg n=165 Participants Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.
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	29.7 percentage of participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Placebo n=164 Participants Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.	Relamorelin 10 μg n=165 Participants Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.
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	27.9 percentage of participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Placebo n=164 Participants Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.	Relamorelin 10 μg n=165 Participants Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.
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	27.9 percentage of participants

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Measure	Placebo n=164 Participants Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.	Relamorelin 10 μg n=165 Participants Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.
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	25.5 percentage of participants

SECONDARY outcome

Timeframe: Up to approximately 16 weeks

Population: Safety Population included all participants who received ≥1 administration of double-blind study treatment.

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.

Outcome measures

Measure	Placebo n=163 Participants Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.	Relamorelin 10 μg n=163 Participants Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.
Number of Participants Who Experienced One or More Treatment-Emergent Adverse Events (TEAE)	68 Participants	70 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Placebo n=163 Participants Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.	Relamorelin 10 μg n=163 Participants Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Lymphocytes Absolute Cell Count (10^9/L): >1.5×ULN	1 Participants	0 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Calcium (mmol/L): <0.9×LLN	0 Participants	1 Participants
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	1 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Hematocrit (RATIO): <0.9×Lower Limit of Normal Value (LLN)	2 Participants	2 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Hemoglobin (g/L): <0.9×LLN	10 Participants	4 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Lymphocytes Absolute Cell Count (10^9/L): <0.8×LLN	2 Participants	1 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Mean Corpuscular Volume [femtoliter (fL)]: >1.1×ULN	2 Participants	0 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Neutrophils Absolute Cell Count (10^9/L): >1.5×ULN	0 Participants	1 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Neutrophils Absolute Cell Count (10^9/L): <0.8×LLN	2 Participants	3 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Platelet Count (Thrombocytes) (10^9/L): >1.5×ULN	0 Participants	1 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Red Blood Cell Count (10^12/L): >1.1×ULN	0 Participants	1 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Red Blood Cell Count (10^12/L): <0.9×LLN	1 Participants	1 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results White Blood Cell Count (10^9/L): >1.5×ULN	1 Participants	1 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Bicarbonate (HCO3) (mmol/L): >1.1×ULN	3 Participants	1 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Bicarbonate (HCO3) (mmol/L): >0.9×LLN	3 Participants	1 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Blood Urea Nitrogen [millimoles(mmol/L)]: >1.2×ULN	11 Participants	11 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Cholesterol, Total, Non-Fasting (mmol/L)	0 Participants	1 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Creatinine [micromoles(μmol/L)]: >1.3×ULN	7 Participants	8 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Glucose-Chemistry, Fasting (mmol/L): >2.5×ULN	10 Participants	21 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Glucose-Chemistry, Fasting (mmol/L): <0.9×LLN	3 Participants	1 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Glycohemoglobin A1C: Increase of >=0.5%	91 Participants	125 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Glycohemoglobin A1C: Increase of >=1%	91 Participants	124 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Phosphorus (mmol/L): >1.1×ULN	2 Participants	5 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Phosphorus (mmol/L): <0.9×LLN	0 Participants	1 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Triglycerides, Fasting (mmol/L): >=3×ULN	5 Participants	5 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Uric Acid (Urate) (μmol/L): >1.1×ULN	10 Participants	18 Participants
Number of Participants With Potential Clinically Significant (PCS) Clinical Laboratory Results Uric Acid (Urate) (μmol/L): <0.9×LLN	1 Participants	3 Participants

SECONDARY outcome

Timeframe: Up to 12 weeks

Population: Safety Population included all participants who received ≥1 administration of double-blind study treatment.

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.

Outcome measures

Measure	Placebo n=163 Participants Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.	Relamorelin 10 μg n=163 Participants Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.
Number of Participants With Clinically Meaningful Trends for Vital Signs	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 12 weeks

Population: Safety Population included all participants who received ≥1 administration of double-blind study treatment.

A standard 12-lead ECG was performed. The investigator determined if the abnormal results were clinically significant.

Outcome measures

Measure	Placebo n=163 Participants Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.	Relamorelin 10 μg n=163 Participants Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.
Number of Participants With Clinically Significant Abnormal Electrocardiogram (ECG) Results	4 Participants	3 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Placebo n=163 Participants Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.	Relamorelin 10 μg n=163 Participants Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.
Number of Participants With a ≥1% Increase in Glycosylated Hemoglobin A1c (HBA1c) Glycohemoglobin A1C: Increase of >=0.5%	91 Participants	125 Participants
Number of Participants With a ≥1% Increase in Glycosylated Hemoglobin A1c (HBA1c) Glycohemoglobin A1C: Increase of >=1%	91 Participants	124 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	Placebo n=163 Participants Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.	Relamorelin 10 μg Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.
Number of Participants With Anti-relamorelin Antibody Testing Results by Visit Screening Test (Day 28) · Positive	16 Participants	—
Number of Participants With Anti-relamorelin Antibody Testing Results by Visit Confirmatory Test (Day 28) · Negative	15 Participants	—
Number of Participants With Anti-relamorelin Antibody Testing Results by Visit Confirmatory Test (Day 84) · Positive	1 Participants	—
Number of Participants With Anti-relamorelin Antibody Testing Results by Visit Screening Test (End of Treatment) · Negative	13 Participants	—
Number of Participants With Anti-relamorelin Antibody Testing Results by Visit Confirmatory Test (End of Treatment) · Positive	0 Participants	—
Number of Participants With Anti-relamorelin Antibody Testing Results by Visit Screening Test (Baseline) · Negative	133 Participants	—
Number of Participants With Anti-relamorelin Antibody Testing Results by Visit Screening Test (Baseline) · Positive	16 Participants	—
Number of Participants With Anti-relamorelin Antibody Testing Results by Visit Confirmatory Test (Baseline) · Negative	13 Participants	—
Number of Participants With Anti-relamorelin Antibody Testing Results by Visit Confirmatory Test (Baseline) · Positive	2 Participants	—
Number of Participants With Anti-relamorelin Antibody Testing Results by Visit Screening Test (Day 14) · Negative	124 Participants	—
Number of Participants With Anti-relamorelin Antibody Testing Results by Visit Screening Test (Day 14) · Positive	13 Participants	—
Number of Participants With Anti-relamorelin Antibody Testing Results by Visit Confirmatory Test (Day 14) · Negative	13 Participants	—
Number of Participants With Anti-relamorelin Antibody Testing Results by Visit Confirmatory Test (Day 14) · Positive	0 Participants	—
Number of Participants With Anti-relamorelin Antibody Testing Results by Visit Screening Test (Day 28) · Negative	115 Participants	—
Number of Participants With Anti-relamorelin Antibody Testing Results by Visit Confirmatory Test (Day 28) · Positive	1 Participants	—
Number of Participants With Anti-relamorelin Antibody Testing Results by Visit Screening Test (Day 84) · Negative	95 Participants	—
Number of Participants With Anti-relamorelin Antibody Testing Results by Visit Screening Test (Day 84) · Positive	16 Participants	—
Number of Participants With Anti-relamorelin Antibody Testing Results by Visit Confirmatory Test (Day 84) · Negative	14 Participants	—
Number of Participants With Anti-relamorelin Antibody Testing Results by Visit Screening Test (End of Treatment) · Positive	2 Participants	—
Number of Participants With Anti-relamorelin Antibody Testing Results by Visit Confirmatory Test (End of Treatment) · Negative	2 Participants	—
Number of Participants With Anti-relamorelin Antibody Testing Results by Visit Screening Test (Unscheduled) · Negative	2 Participants	—
Number of Participants With Anti-relamorelin Antibody Testing Results by Visit Screening Test (Unscheduled) · Positive	2 Participants	—
Number of Participants With Anti-relamorelin Antibody Testing Results by Visit Confirmatory Test (Unscheduled) · Negative	1 Participants	—
Number of Participants With Anti-relamorelin Antibody Testing Results by Visit Confirmatory Test (Unscheduled) · Positive	1 Participants	—

Adverse Events

Placebo

Serious events: 15 serious events

Other events: 9 other events

Deaths: 0 deaths

Relamorelin 10 μg

Serious events: 16 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=163 participants at risk Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.	Relamorelin 10 μg n=163 participants at risk Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.
Blood and lymphatic system disorders Anaemia	0.00% 0/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.	0.61% 1/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
Blood and lymphatic system disorders Leukopenia	0.61% 1/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.	0.00% 0/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
Blood and lymphatic system disorders Thrombocytopenia	0.61% 1/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.	0.00% 0/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
Cardiac disorders Angina pectoris	0.61% 1/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.	0.61% 1/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
Cardiac disorders Angina unstable	0.00% 0/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.	0.61% 1/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
Cardiac disorders Atrial fibrillation	0.61% 1/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.	0.00% 0/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
Cardiac disorders Cardiac failure congestive	0.61% 1/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.	0.00% 0/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
Gastrointestinal disorders Vomiting	0.61% 1/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.	0.61% 1/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
Gastrointestinal disorders Colitis	0.00% 0/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.	0.61% 1/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
Gastrointestinal disorders Constipation	0.00% 0/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.	0.61% 1/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.	0.61% 1/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
Gastrointestinal disorders Impaired gastric emptying	0.00% 0/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.	0.61% 1/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
Gastrointestinal disorders Diabetic gastroparesis	0.61% 1/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.	0.00% 0/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
Gastrointestinal disorders Pancreatitis	0.61% 1/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.	0.00% 0/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
Infections and infestations Pneumonia	1.8% 3/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.	1.2% 2/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
Infections and infestations Diverticulitis	0.00% 0/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.	1.2% 2/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
Infections and infestations Urinary tract infection	1.2% 2/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.	0.61% 1/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
Infections and infestations Acute sinusitis	0.00% 0/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.	0.61% 1/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
Infections and infestations Sepsis	1.2% 2/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.	0.00% 0/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
Infections and infestations Cystitis	0.61% 1/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.	0.00% 0/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
Infections and infestations Pyelonephritis acute	0.61% 1/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.	0.00% 0/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
Injury, poisoning and procedural complications Fall	1.2% 2/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.	1.2% 2/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
Injury, poisoning and procedural complications Thoracic vertebral fracture	0.00% 0/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.	0.61% 1/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
Injury, poisoning and procedural complications Ankle fracture	0.61% 1/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.	0.00% 0/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
Injury, poisoning and procedural complications Tibia fracture	0.61% 1/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.	0.00% 0/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
Investigations Anticoagulation drug level above therapeutic	0.61% 1/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.	0.00% 0/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.	0.61% 1/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
Metabolism and nutrition disorders Dehydration	0.61% 1/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.	0.00% 0/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
Metabolism and nutrition disorders Diabetes mellitus	0.61% 1/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.	0.00% 0/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
Metabolism and nutrition disorders Hyperglycaemia	0.61% 1/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.	0.00% 0/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
Metabolism and nutrition disorders Hyperglycaemic hyperosmolar nonketotic syndrome	0.61% 1/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.	0.00% 0/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
Metabolism and nutrition disorders Hypomagnesaemia	0.61% 1/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.	0.00% 0/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.	0.61% 1/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
Musculoskeletal and connective tissue disorders Cervical spinal stenosis	0.61% 1/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.	0.00% 0/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
Musculoskeletal and connective tissue disorders Vertebral wedging	0.61% 1/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.	0.00% 0/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
Nervous system disorders Syncope	0.00% 0/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.	0.61% 1/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
Renal and urinary disorders Acute kidney injury	1.2% 2/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.	0.61% 1/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
Renal and urinary disorders Diabetic nephropathy	0.61% 1/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.	0.00% 0/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
Renal and urinary disorders Hydronephrosis	0.61% 1/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.	0.00% 0/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
Renal and urinary disorders Nephrolithiasis	0.61% 1/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.	0.00% 0/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	1.2% 2/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.	0.00% 0/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
Respiratory, thoracic and mediastinal disorders Asthma	0.61% 1/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.	0.00% 0/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
Respiratory, thoracic and mediastinal disorders Hypercapnia	0.61% 1/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.	0.00% 0/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.61% 1/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.	0.00% 0/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.61% 1/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.	0.00% 0/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.61% 1/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.	0.00% 0/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
Vascular disorders Hypertension	0.61% 1/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.	0.61% 1/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.
Vascular disorders Hypovolaemic shock	0.61% 1/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.	0.00% 0/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.

Other adverse events

Measure	Placebo n=163 participants at risk Following a 2-week placebo run-in, participants received placebo-matching relamorelin injected subcutaneously twice daily for up to 12 weeks.	Relamorelin 10 μg n=163 participants at risk Following a 2-week placebo run-in, participants received relamorelin 10 μg injected subcutaneously twice daily for up to 12 weeks.
Metabolism and nutrition disorders Hyperglycaemia	5.5% 9/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.	5.5% 9/163 • Up to approximately 16 weeks All-Cause Mortality is based on the Intent-to-treat (ITT) Population. Safety Population, all participants who received ≥1 administration of double-blind study treatment, was used to determine the number of participants at risk for Serious Adverse Events and Other Adverse Events.

Additional Information

Therapeutic Area, Head

Allergan

Phone: 714-246-4500

Email: clinicaltrials@allergan.com

Results disclosure agreements

• Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
• Publication restrictions are in place

Restriction type: OTHER