Trial Outcomes & Findings for A Trial of Setmelanotide in Acquired Hypothalamic Obesity (NCT NCT05774756)
NCT ID: NCT05774756
Last Updated: 2026-05-29
Results Overview
BMI was calculated as weight (kg)/height (m\^2). Least square (LS) mean and standard error (SE) were calculated using analysis of covariance (ANCOVA) model.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
143 participants
Primary outcome timeframe
Baseline, after approximately 52 Weeks on a Therapeutic Regimen (up to approximately 60 weeks)
Results posted on
2026-05-29
Participant Flow
As planned, the analysis of the primary and secondary efficacy endpoints were done only in the pivotal cohort. Pivotal cohort: defined as the first 120 participants dosed in any region who had completed the trial and any participants who discontinued after receiving their first dose of study drug.
Participant milestones
| Measure |
Setmelanotide
Participants received setmelanotide once daily (QD) as a subcutaneous (SC) injection for approximately 52 weeks on a therapeutic regimen (up to approximately 60 weeks).
|
Placebo
Participants received placebo matched to setmelanotide QD as a SC injection for approximately 52 weeks on a therapeutic regimen (up to approximately 60 weeks).
|
|---|---|---|
|
Overall Study
STARTED
|
95
|
48
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
94
|
48
|
|
Overall Study
Modified Intent to Treat Pivotal Cohort
|
81
|
39
|
|
Overall Study
COMPLETED
|
72
|
38
|
|
Overall Study
NOT COMPLETED
|
23
|
10
|
Reasons for withdrawal
| Measure |
Setmelanotide
Participants received setmelanotide once daily (QD) as a subcutaneous (SC) injection for approximately 52 weeks on a therapeutic regimen (up to approximately 60 weeks).
|
Placebo
Participants received placebo matched to setmelanotide QD as a SC injection for approximately 52 weeks on a therapeutic regimen (up to approximately 60 weeks).
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
1
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
1
|
|
Overall Study
Randomized, not treated
|
1
|
0
|
|
Overall Study
Ongoing
|
13
|
8
|
|
Overall Study
Withdrawal by Parent/Guardian
|
1
|
0
|
Baseline Characteristics
Participants in pivotal cohort have been reported for this measure.
Baseline characteristics by cohort
| Measure |
Setmelanotide
n=94 Participants
Participants received setmelanotide QD as a SC injection for approximately 52 weeks on a therapeutic regimen (up to approximately 60 weeks).
|
Placebo
n=48 Participants
Participants received placebo matched to setmelanotide QD as a SC injection for approximately 52 weeks on a therapeutic regimen (up to approximately 60 weeks).
|
Total
n=142 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
20.6 years
STANDARD_DEVIATION 13.35 • n=94 Participants
|
22.9 years
STANDARD_DEVIATION 16.31 • n=48 Participants
|
21.4 years
STANDARD_DEVIATION 14.40 • n=142 Participants
|
|
Sex: Female, Male
Female
|
54 Participants
n=94 Participants
|
31 Participants
n=48 Participants
|
85 Participants
n=142 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=94 Participants
|
17 Participants
n=48 Participants
|
57 Participants
n=142 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=94 Participants
|
8 Participants
n=48 Participants
|
16 Participants
n=142 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
85 Participants
n=94 Participants
|
40 Participants
n=48 Participants
|
125 Participants
n=142 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=94 Participants
|
0 Participants
n=48 Participants
|
1 Participants
n=142 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=94 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=142 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=94 Participants
|
5 Participants
n=48 Participants
|
16 Participants
n=142 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=94 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=142 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=94 Participants
|
1 Participants
n=48 Participants
|
7 Participants
n=142 Participants
|
|
Race (NIH/OMB)
White
|
71 Participants
n=94 Participants
|
36 Participants
n=48 Participants
|
107 Participants
n=142 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=94 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=142 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=94 Participants
|
6 Participants
n=48 Participants
|
12 Participants
n=142 Participants
|
|
Region of Enrollment
Canada
|
5 participants
n=94 Participants
|
3 participants
n=48 Participants
|
8 participants
n=142 Participants
|
|
Region of Enrollment
Netherlands
|
7 participants
n=94 Participants
|
5 participants
n=48 Participants
|
12 participants
n=142 Participants
|
|
Region of Enrollment
United States
|
57 participants
n=94 Participants
|
31 participants
n=48 Participants
|
88 participants
n=142 Participants
|
|
Region of Enrollment
Japan
|
8 participants
n=94 Participants
|
4 participants
n=48 Participants
|
12 participants
n=142 Participants
|
|
Region of Enrollment
United Kingdom
|
9 participants
n=94 Participants
|
1 participants
n=48 Participants
|
10 participants
n=142 Participants
|
|
Region of Enrollment
Germany
|
8 participants
n=94 Participants
|
4 participants
n=48 Participants
|
12 participants
n=142 Participants
|
|
Body Mass Index
|
35.73 kilograms (kg)/square meter (m^2)
STANDARD_DEVIATION 9.173 • n=81 Participants • Participants in pivotal cohort have been reported for this measure.
|
36.78 kilograms (kg)/square meter (m^2)
STANDARD_DEVIATION 9.332 • n=39 Participants • Participants in pivotal cohort have been reported for this measure.
|
36.07 kilograms (kg)/square meter (m^2)
STANDARD_DEVIATION 9.199 • n=120 Participants • Participants in pivotal cohort have been reported for this measure.
|
PRIMARY outcome
Timeframe: Baseline, after approximately 52 Weeks on a Therapeutic Regimen (up to approximately 60 weeks)Population: mITT analysis set included all randomized participants who were exposed to at least 1 dose of study treatment. Participants in pivotal cohort were included in the analysis.
BMI was calculated as weight (kg)/height (m\^2). Least square (LS) mean and standard error (SE) were calculated using analysis of covariance (ANCOVA) model.
Outcome measures
| Measure |
Placebo
n=39 Participants
Participants received placebo matched to setmelanotide QD as a SC injection for approximately 52 weeks on a therapeutic regimen (up to approximately 60 weeks).
|
Setmelanotide
n=81 Participants
Participants received setmelanotide QD as a SC injection for approximately 52 weeks on a therapeutic regimen (up to approximately 60 weeks).
|
|---|---|---|
|
Pivotal Cohort: Mean Percent Change From Baseline in Body Mass Index (BMI) After 52 Weeks on a Therapeutic Regimen
|
3.32 Percent change
Standard Error 1.984
|
-16.51 Percent change
Standard Error 1.401
|
SECONDARY outcome
Timeframe: After approximately 52 Weeks on a Therapeutic Regimen (baseline up to approximately 60 weeks)Population: mITT analysis set included all randomized participants who were exposed to at least 1 dose of study treatment. Participants in pivotal cohort were included in the analysis.
BMI was calculated as weight (kg)/height (m\^2). BMI Z-Score calculated for participants \<18 years old only is a measure of relative weight adjusted for child's age, sex and height at the time of data collection. The Z-Scores were calculated using the World Health Organization's WHO 2007 BMI SAS Macro Package. A Z-score of 0 is equal to the mean of a reference population (i.e., healthy, age and sex-matched individuals). A decrease in BMI Z-score (\< 0) indicates a reduction in BMI from Baseline whereas an increase in BMI-Z score (\> 0) indicated an increase in BMI from Baseline. Baseline was defined as the most recent measurement prior to the first administration of study drug. Results below represent the percentage of estimated participants with either ≥5% BMI reduction or ≥0.2 point reduction in BMI Z-score by age in each treatment arm as calculated through the MIANALYZE SAS procedure.
Outcome measures
| Measure |
Placebo
n=39 Participants
Participants received placebo matched to setmelanotide QD as a SC injection for approximately 52 weeks on a therapeutic regimen (up to approximately 60 weeks).
|
Setmelanotide
n=81 Participants
Participants received setmelanotide QD as a SC injection for approximately 52 weeks on a therapeutic regimen (up to approximately 60 weeks).
|
|---|---|---|
|
Pivotal Cohort: Percentage of Participants With ≥5% Reduction From Baseline in BMI (≥18 Years of Age) or ≥0.2-point Reduction From Baseline in BMI Z-score (<18 Years of Age)
|
20.90 Calculated estimate: % of participants
Interval 8.01 to 33.78
|
82.73 Calculated estimate: % of participants
Interval 74.13 to 91.33
|
SECONDARY outcome
Timeframe: After approximately 52 Weeks on a Therapeutic Regimen (baseline up to approximately 60 weeks)Population: mITT analysis set included all randomized participants who were exposed to at least 1 dose of study treatment. Participants in pivotal cohort were included in the analysis.
BMI was calculated as weight (kg)/height (m\^2). Results below represent the percentage of estimated participants with ≥5% BMI reduction in each treatment arm as calculated through the MIANALYZE SAS procedure.
Outcome measures
| Measure |
Placebo
n=39 Participants
Participants received placebo matched to setmelanotide QD as a SC injection for approximately 52 weeks on a therapeutic regimen (up to approximately 60 weeks).
|
Setmelanotide
n=81 Participants
Participants received setmelanotide QD as a SC injection for approximately 52 weeks on a therapeutic regimen (up to approximately 60 weeks).
|
|---|---|---|
|
Pivotal Cohort: Percentage of Participants With ≥5% Reduction From Baseline in BMI
|
10.41 Calculated estimate: % of participants
Interval 0.75 to 20.07
|
79.53 Calculated estimate: % of participants
Interval 70.6 to 88.47
|
SECONDARY outcome
Timeframe: Baseline, after approximately 52 Weeks on a Therapeutic Regimen (up to approximately 60 weeks)Population: mITT analysis set included all randomized participants who were exposed to at least 1 dose of study treatment. Participants in pivotal cohort who were evaluable for this outcome measure were included in the analysis.
Change from baseline in hunger scores for participants ≥12 years of age with acquired hypothalamic obesity was evaluated. Hunger score ranged from 0= "not hungry at all" to 10= "hungriest possible" on an 11-point numeric rating scale. On Daily Hunger Questionnaire, each of the 2 items (average hunger and most hunger) was scored separately and averaged on weekly basis. LSM and SE were calculated using ANCOVA model.
Outcome measures
| Measure |
Placebo
n=24 Participants
Participants received placebo matched to setmelanotide QD as a SC injection for approximately 52 weeks on a therapeutic regimen (up to approximately 60 weeks).
|
Setmelanotide
n=57 Participants
Participants received setmelanotide QD as a SC injection for approximately 52 weeks on a therapeutic regimen (up to approximately 60 weeks).
|
|---|---|---|
|
Pivotal Cohort: Change From Baseline in Weekly Average Daily Most Hunger Score in Participants ≥12 Years of Age
|
-1.45 Score on a scale
Standard Error 0.399
|
-2.73 Score on a scale
Standard Error 0.279
|
SECONDARY outcome
Timeframe: After approximately 52 Weeks on a Therapeutic Regimen (baseline up to approximately 60 weeks)Population: mITT analysis set included all randomized participants who were exposed to at least 1 dose of study treatment. Participants in pivotal cohort who were evaluable for this outcome measure were included in the analysis.
Hunger score ranged from 0= "not hungry at all" to 10= "hungriest possible" on an 11-point numeric rating scale. On Daily Hunger Questionnaire, each of the 2 items (average hunger and most hunger) was scored separately and averaged on weekly basis. Results below represent the percentage of estimated participants ≥12 years of age with ≥2-point reduction in each treatment arm as calculated through the MIANALYZE SAS procedure.
Outcome measures
| Measure |
Placebo
n=28 Participants
Participants received placebo matched to setmelanotide QD as a SC injection for approximately 52 weeks on a therapeutic regimen (up to approximately 60 weeks).
|
Setmelanotide
n=61 Participants
Participants received setmelanotide QD as a SC injection for approximately 52 weeks on a therapeutic regimen (up to approximately 60 weeks).
|
|---|---|---|
|
Pivotal Cohort: Percentage of Participants (≥12 Years of Age) With a ≥2-point Reduction From Baseline in the Weekly Average Daily Most Hunger Score
|
45.04 Calculated estimate: % of participants
Interval 24.56 to 65.52
|
61.04 Calculated estimate: % of participants
Interval 47.01 to 75.06
|
SECONDARY outcome
Timeframe: Baseline, after approximately 52 Weeks on a Therapeutic Regimen (up to approximately 60 weeks)Population: mITT analysis set included all randomized participants who were exposed to at least 1 dose of study treatment. Participants in pivotal cohort who were evaluable for this outcome measure were included in the analysis.
Participants ≥12 years of age who were able to self-report were administered the Symptoms of Hyperphagia: Patient (Version 1.0). The questionnaire consisted of 4 items related to the frequency of a participant's hunger symptoms on a scale (Never, 1 or 2 times, 3 or more times) over the past 24 hours. The scores on this scale range from 0 to 2 with higher scores indicating more hyperphagia. Daily composite score was derived as the sum of daily answered questions divided by the number of answered questions per day. The weekly average of the daily composite scores equals to the sum of daily composite scores divided by the number of days with a composite score within the 7 identified days prior to the visit. LSM and SE were calculated using ANCOVA model.
Outcome measures
| Measure |
Placebo
n=16 Participants
Participants received placebo matched to setmelanotide QD as a SC injection for approximately 52 weeks on a therapeutic regimen (up to approximately 60 weeks).
|
Setmelanotide
n=33 Participants
Participants received setmelanotide QD as a SC injection for approximately 52 weeks on a therapeutic regimen (up to approximately 60 weeks).
|
|---|---|---|
|
Pivotal Cohort: Mean Change From Baseline in the Weekly Average of the Symptoms of Hyperphagia Composite Score in Participants ≥12 Years of Age
|
-0.14 Score on a scale
Standard Error 0.042
|
-0.30 Score on a scale
Standard Error 0.029
|
SECONDARY outcome
Timeframe: After approximately 52 Weeks on a Therapeutic Regimen (baseline up to approximately 60 weeks)Population: mITT analysis set included all randomized participants who were exposed to at least 1 dose of study treatment. Participants in pivotal cohort were included in the analysis.
BMI was calculated as weight (kg)/height (m\^2). Results below represent the percentage of estimated participants with ≥10% BMI reduction in each treatment arm as calculated through the MIANALYZE SAS procedure.
Outcome measures
| Measure |
Placebo
n=39 Participants
Participants received placebo matched to setmelanotide QD as a SC injection for approximately 52 weeks on a therapeutic regimen (up to approximately 60 weeks).
|
Setmelanotide
n=81 Participants
Participants received setmelanotide QD as a SC injection for approximately 52 weeks on a therapeutic regimen (up to approximately 60 weeks).
|
|---|---|---|
|
Pivotal Cohort: Percentage of Participants With a ≥10% Reduction From Baseline in BMI
|
5.18 Calculated estimate: % of participants
Interval 0.0 to 12.17
|
63.02 Calculated estimate: % of participants
Interval 52.5 to 73.55
|
SECONDARY outcome
Timeframe: After approximately 52 Weeks on a Therapeutic Regimen (baseline up to approximately 60 weeks)Population: mITT analysis set included all randomized participants who were exposed to at least 1 dose of study treatment. Participants in pivotal cohort were included in the analysis.
Body weight was captured for analysis in kilograms. Results below represent the percentage of estimated participants with ≥10% reduction in body weight in each treatment arm as calculated through the MIANALYZE SAS procedure.
Outcome measures
| Measure |
Placebo
n=39 Participants
Participants received placebo matched to setmelanotide QD as a SC injection for approximately 52 weeks on a therapeutic regimen (up to approximately 60 weeks).
|
Setmelanotide
n=81 Participants
Participants received setmelanotide QD as a SC injection for approximately 52 weeks on a therapeutic regimen (up to approximately 60 weeks).
|
|---|---|---|
|
Pivotal Cohort: Percentage of Participants With a ≥10% Reduction From Baseline in Body Weight
|
0.05 Calculated estimate: % of participants
Interval 0.0 to 1.05
|
55.60 Calculated estimate: % of participants
Interval 44.77 to 66.44
|
SECONDARY outcome
Timeframe: Baseline, after approximately 52 Weeks on a Therapeutic Regimen (up to approximately 60 weeks)Population: mITT analysis set included all randomized participants who were exposed to at least 1 dose of study treatment. Participants in pivotal cohort who were evaluable for this outcome measure were included in the analysis.
Body weight was captured for analysis in kilograms. LSM and SE were calculated using ANCOVA model.
Outcome measures
| Measure |
Placebo
n=16 Participants
Participants received placebo matched to setmelanotide QD as a SC injection for approximately 52 weeks on a therapeutic regimen (up to approximately 60 weeks).
|
Setmelanotide
n=33 Participants
Participants received setmelanotide QD as a SC injection for approximately 52 weeks on a therapeutic regimen (up to approximately 60 weeks).
|
|---|---|---|
|
Pivotal Cohort: Mean Percent Change From Baseline in Body Weight in Participants ≥18 Years
|
2.44 Percent change
Standard Error 3.228
|
-16.51 Percent change
Standard Error 2.297
|
SECONDARY outcome
Timeframe: Baseline, after approximately 52 Weeks on a Therapeutic Regimen (up to approximately 60 weeks)Population: mITT analysis set included all randomized participants who were exposed to at least 1 dose of study treatment. Participants in pivotal cohort who were evaluable for this outcome measure were included in the analysis.
BMI was calculated as weight (kg)/height (m\^2). BMI Z-Score calculated for participants \<18 years old only is a measure of relative weight adjusted for child's age, sex and height at the time of data collection. The Z-Scores were calculated using the World Health Organization's WHO 2007 BMI SAS Macro Package. A Z-score of 0 is equal to the mean of a reference population (i.e., healthy, age and sex-matched individuals). A decrease in BMI Z-score (\< 0) indicates a reduction in BMI from Baseline whereas an increase in BMI-Z score (\> 0) indicates an increase in BMI from Baseline. Baseline was defined as the most recent measurement prior to the first administration of study drug. LSM and SE were calculated using ANCOVA model.
Outcome measures
| Measure |
Placebo
n=23 Participants
Participants received placebo matched to setmelanotide QD as a SC injection for approximately 52 weeks on a therapeutic regimen (up to approximately 60 weeks).
|
Setmelanotide
n=45 Participants
Participants received setmelanotide QD as a SC injection for approximately 52 weeks on a therapeutic regimen (up to approximately 60 weeks).
|
|---|---|---|
|
Pivotal Cohort: Mean Change From Baseline in BMI Z-Score in Participants <18 Years of Age
|
-0.12 Z-Score
Standard Error 0.180
|
-1.47 Z-Score
Standard Error 0.129
|
SECONDARY outcome
Timeframe: Baseline, after approximately 52 Weeks on a Therapeutic Regimen (up to approximately 60 weeks)Population: mITT analysis set included all randomized participants who were exposed to at least 1 dose of study treatment. Participants in pivotal cohort who were evaluable for this outcome measure were included in the analysis.
BMI was calculated using participant's weight and height assessments, using the following formula: BMI = kg/m\^2. BMI percentile scores are measures of relative weight adjusted for child's age and gender. The percent of the BMI 95th percentile score expresses the participant's BMI as a percentage of the Centers for Disease Control (CDC) 95th percentile reference population. Baseline was defined as the most recent measurement prior to the first administration of study drug. LSM and SE were calculated using ANCOVA model.
Outcome measures
| Measure |
Placebo
n=23 Participants
Participants received placebo matched to setmelanotide QD as a SC injection for approximately 52 weeks on a therapeutic regimen (up to approximately 60 weeks).
|
Setmelanotide
n=48 Participants
Participants received setmelanotide QD as a SC injection for approximately 52 weeks on a therapeutic regimen (up to approximately 60 weeks).
|
|---|---|---|
|
Pivotal Cohort: Mean Change From Baseline in Percent of BMI 95th Percentile in Participants <18 Years of Age
|
-0.14 Percent of BMI 95th Percentile
Standard Error 3.284
|
-26.30 Percent of BMI 95th Percentile
Standard Error 2.279
|
SECONDARY outcome
Timeframe: After approximately 52 Weeks on a Therapeutic Regimen (baseline up to approximately 60 weeks)Population: mITT analysis set included all randomized participants who were exposed to at least 1 dose of study treatment. Participants in pivotal cohort who were evaluable for this outcome measure were included in the analysis.
BMI was calculated as weight (kg)/height (m\^2). BMI Z-Score calculated for participants \<18 years old only is a measure of relative weight adjusted for child's age, sex and height at the time of data collection. The Z-Scores were calculated using the World Health Organization's WHO 2007 BMI SAS Macro Package. A Z-score of 0 is equal to the mean of a reference population (i.e., healthy, age and sex-matched individuals). A decrease in BMI Z-score (\< 0) indicates a reduction in BMI from Baseline whereas an increase in BMI-Z score (\> 0) indicates an increase in BMI from Baseline. Baseline was defined as the most recent measurement prior to the first administration of study drug. Results below represent the percentage of estimated participants with ≥0.2 point reduction in BMI Z-score in each treatment arm and the difference between the treatment arms as calculated through the MIANALYZE SAS procedure.
Outcome measures
| Measure |
Placebo
n=23 Participants
Participants received placebo matched to setmelanotide QD as a SC injection for approximately 52 weeks on a therapeutic regimen (up to approximately 60 weeks).
|
Setmelanotide
n=48 Participants
Participants received setmelanotide QD as a SC injection for approximately 52 weeks on a therapeutic regimen (up to approximately 60 weeks).
|
|---|---|---|
|
Pivotal Cohort: Percentage of Participants <18 Years of Age With ≥0.2-Point Reduction From Baseline in BMI Z-Score
|
31.09 Calculated estimate: % of participants
Interval 11.93 to 50.24
|
89.31 Calculated estimate: % of participants
Interval 80.08 to 98.54
|
SECONDARY outcome
Timeframe: After approximately 52 Weeks on a Therapeutic Regimen (baseline up to approximately 60 weeks)Population: mITT analysis set included all randomized participants who were exposed to at least 1 dose of study treatment. Participants in pivotal cohort were included in the analysis.
BMI was calculated using participant's weight and height assessments, using the following formula: BMI = kg/m\^2. BMI Percentile scores are measures of relative weight adjusted for child's age and gender. The percent of the BMI 95th percentile score expresses the participant's BMI as a percentage of the CDC 95th percentile reference population. Baseline was defined as the most recent measurement prior to the first administration of study drug. Results below represent the percentage of estimated participants with either BMI \<30 kg/m\^2 (aged ≥18 years) or \<95th percentile (aged \<18 years) in each treatment arm and the difference between the treatment arms as calculated through the MIANALYZE SAS procedure.
Outcome measures
| Measure |
Placebo
n=39 Participants
Participants received placebo matched to setmelanotide QD as a SC injection for approximately 52 weeks on a therapeutic regimen (up to approximately 60 weeks).
|
Setmelanotide
n=81 Participants
Participants received setmelanotide QD as a SC injection for approximately 52 weeks on a therapeutic regimen (up to approximately 60 weeks).
|
|---|---|---|
|
Pivotal Cohort: Percentage of Participants With BMI <30 kg/m^2 (Aged ≥18 Years) or <95th Percentile (Aged <18 Years) From Baseline
|
12.82 Calculated estimate: % of participants
Interval 4.3 to 27.43
|
39.95 Calculated estimate: % of participants
Interval 29.18 to 50.72
|
SECONDARY outcome
Timeframe: Baseline, after approximately 52 Weeks on a Therapeutic Regimen (up to approximately 60 weeks)Population: mITT analysis set included all randomized participants who were exposed to at least 1 dose of study treatment. Participants in pivotal cohort who were evaluable for this outcome measure were included in the analysis.
The IWQOL-Lite-Clinical Trials (administered to participants ≥18 years of age) is a validated 20-item self-report measure of obesity-specific quality of life questionnaire. It assessed 2 primary domains of obesity-related health-related quality of life (HRQoL): physical (7 items) and psychosocial (13 items). Each item was rated on a scale from 0 (worst) to 100 (best), with higher scores indicating better levels of functioning. It provided composite scores for each domain, as well as a total score, all ranging from 0 (worst) to 100 (best). Higher scores reflect better levels of functioning and quality of life. LSM and SE were calculated using ANCOVA model.
Outcome measures
| Measure |
Placebo
n=13 Participants
Participants received placebo matched to setmelanotide QD as a SC injection for approximately 52 weeks on a therapeutic regimen (up to approximately 60 weeks).
|
Setmelanotide
n=25 Participants
Participants received setmelanotide QD as a SC injection for approximately 52 weeks on a therapeutic regimen (up to approximately 60 weeks).
|
|---|---|---|
|
Pivotal Cohort: Mean Change From Baseline in Physical Functioning Score and Total Score on the Impact of Weight on Quality of Life-Lite (IWQOL)
IWQOL-Lite-CT-Physical Function Score
|
-4.46 Score on a scale
Standard Error 5.145
|
31.32 Score on a scale
Standard Error 3.702
|
|
Pivotal Cohort: Mean Change From Baseline in Physical Functioning Score and Total Score on the Impact of Weight on Quality of Life-Lite (IWQOL)
IWQOL-Lite-CT-Total Score
|
3.00 Score on a scale
Standard Error 4.249
|
32.04 Score on a scale
Standard Error 3.059
|
SECONDARY outcome
Timeframe: Baseline, after approximately 52 Weeks on a Therapeutic Regimen (up to approximately 60 weeks)Population: mITT analysis set included all randomized participants who were exposed to at least 1 dose of study treatment. Participants in pivotal cohort who were evaluable for this outcome measure were included in the analysis.
The IWQOL-Kids (administered to participants between the ages of 11 and \<18 years) is a validated 27-item self-report measure of weight-related quality of life for youth. It provided a total score inclusive of 4 domains: physical comfort, body esteem, social life, and family relations. Results below represent the total score, which is rated on a scale from 0 (worst) to 100 (best), with higher scores indicating better levels of functioning. LSM and SE were calculated using ANCOVA model.
Outcome measures
| Measure |
Placebo
n=11 Participants
Participants received placebo matched to setmelanotide QD as a SC injection for approximately 52 weeks on a therapeutic regimen (up to approximately 60 weeks).
|
Setmelanotide
n=17 Participants
Participants received setmelanotide QD as a SC injection for approximately 52 weeks on a therapeutic regimen (up to approximately 60 weeks).
|
|---|---|---|
|
Pivotal Cohort: Mean Change From Baseline in Total Score on the Impact of Weight on Quality of Life-Kids (IWQOL-Kids)
|
7.92 Score on a scale
Standard Error 4.001
|
22.05 Score on a scale
Standard Error 4.708
|
SECONDARY outcome
Timeframe: Baseline, after approximately 52 Weeks on a Therapeutic Regimen (up to approximately 60 weeks)Population: mITT analysis set included all randomized participants who were exposed to at least 1 dose of study treatment. Participants in pivotal cohort who were evaluable for this outcome measure were included in the analysis.
Waist circumference was captured for analysis in centimeters. LSM and SE were calculated using ANCOVA model.
Outcome measures
| Measure |
Placebo
n=37 Participants
Participants received placebo matched to setmelanotide QD as a SC injection for approximately 52 weeks on a therapeutic regimen (up to approximately 60 weeks).
|
Setmelanotide
n=71 Participants
Participants received setmelanotide QD as a SC injection for approximately 52 weeks on a therapeutic regimen (up to approximately 60 weeks).
|
|---|---|---|
|
Pivotal Cohort: Mean Change From Baseline in Waist Circumference
|
3.85 Centimeters
Standard Error 1.584
|
-11.58 Centimeters
Standard Error 1.161
|
SECONDARY outcome
Timeframe: Baseline, after approximately 52 Weeks on a Therapeutic Regimen (up to approximately 60 weeks)Population: mITT analysis set included all randomized participants who were exposed to at least 1 dose of study treatment. Participants in pivotal cohort who were evaluable for this outcome measure were included in the analysis.
Blood pressure was calculated in millimeters of mercury.
Outcome measures
| Measure |
Placebo
n=37 Participants
Participants received placebo matched to setmelanotide QD as a SC injection for approximately 52 weeks on a therapeutic regimen (up to approximately 60 weeks).
|
Setmelanotide
n=73 Participants
Participants received setmelanotide QD as a SC injection for approximately 52 weeks on a therapeutic regimen (up to approximately 60 weeks).
|
|---|---|---|
|
Pivotal Cohort: Change From Baseline in Systolic and Diastolic Blood Pressure
Systolic blood pressure
|
2.84 Millimeters of mercury
Standard Deviation 11.438
|
-2.16 Millimeters of mercury
Standard Deviation 11.587
|
|
Pivotal Cohort: Change From Baseline in Systolic and Diastolic Blood Pressure
Diastolic blood pressure
|
2.71 Millimeters of mercury
Standard Deviation 9.789
|
-0.88 Millimeters of mercury
Standard Deviation 7.480
|
Adverse Events
Setmelanotide
Serious events: 26 serious events
Other events: 94 other events
Deaths: 2 deaths
Placebo
Serious events: 3 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Setmelanotide
n=94 participants at risk
Participants received setmelanotide solution QD as a SC injection for approximately 52 weeks on a therapeutic regimen (up to approximately 60 weeks).
|
Placebo
n=48 participants at risk
Participants received placebo matched to setmelanotide solution QD as a SC injection for approximately 52 weeks on a therapeutic regimen (up to approximately 60 weeks).
|
|---|---|---|
|
Infections and infestations
COVID-19
|
2.1%
2/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
0.00%
0/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
Infections and infestations
Cellulitis
|
2.1%
2/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
0.00%
0/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
Infections and infestations
Appendicitis
|
1.1%
1/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
0.00%
0/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
Infections and infestations
Gastroenteritis
|
1.1%
1/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
0.00%
0/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
Infections and infestations
Localised infection
|
1.1%
1/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
0.00%
0/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
Infections and infestations
Lower respiratory tract infection
|
1.1%
1/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
0.00%
0/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
Infections and infestations
Norovirus infection
|
1.1%
1/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
0.00%
0/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
Infections and infestations
Pyelonephritis
|
1.1%
1/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
0.00%
0/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
Infections and infestations
Streptococcal sepsis
|
1.1%
1/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
0.00%
0/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
Infections and infestations
Viral infection
|
1.1%
1/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
0.00%
0/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
Nervous system disorders
Altered state of consciousness
|
1.1%
1/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
0.00%
0/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
Nervous system disorders
Carotid artery aneurysm
|
0.00%
0/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
2.1%
1/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
Nervous system disorders
Cerebral artery stenosis
|
1.1%
1/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
0.00%
0/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
Nervous system disorders
Headache
|
1.1%
1/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
0.00%
0/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
Nervous system disorders
Loss of consciousness
|
1.1%
1/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
0.00%
0/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
Nervous system disorders
Seizure
|
1.1%
1/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
0.00%
0/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
Nervous system disorders
Status migrainosus
|
0.00%
0/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
2.1%
1/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
Endocrine disorders
Adrenal insufficiency
|
3.2%
3/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
0.00%
0/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
Endocrine disorders
Adrenocortical insufficiency acute
|
2.1%
2/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
0.00%
0/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
2.1%
2/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
2.1%
1/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.1%
1/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
0.00%
0/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
Gastrointestinal disorders
Vomiting
|
1.1%
1/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
2.1%
1/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
Gastrointestinal disorders
Haematemesis
|
1.1%
1/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
0.00%
0/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
Gastrointestinal disorders
Nausea
|
1.1%
1/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
0.00%
0/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
Eye disorders
Vision blurred
|
1.1%
1/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
0.00%
0/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
General disorders
Catheter site erosion
|
1.1%
1/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
0.00%
0/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
Hepatobiliary disorders
Cholecystitis
|
1.1%
1/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
0.00%
0/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
Immune system disorders
Anaphylactic reaction
|
1.1%
1/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
0.00%
0/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
Injury, poisoning and procedural complications
Concussion
|
1.1%
1/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
0.00%
0/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
Investigations
Blood sodium abnormal
|
1.1%
1/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
0.00%
0/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
1.1%
1/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
0.00%
0/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
Vascular disorders
Hypertension
|
1.1%
1/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
0.00%
0/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
Other adverse events
| Measure |
Setmelanotide
n=94 participants at risk
Participants received setmelanotide solution QD as a SC injection for approximately 52 weeks on a therapeutic regimen (up to approximately 60 weeks).
|
Placebo
n=48 participants at risk
Participants received placebo matched to setmelanotide solution QD as a SC injection for approximately 52 weeks on a therapeutic regimen (up to approximately 60 weeks).
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
52.1%
49/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
35.4%
17/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
Gastrointestinal disorders
Vomiting
|
38.3%
36/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
29.2%
14/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
Gastrointestinal disorders
Diarrhoea
|
20.2%
19/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
29.2%
14/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
Gastrointestinal disorders
Abdominal pain
|
12.8%
12/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
14.6%
7/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
Gastrointestinal disorders
Constipation
|
11.7%
11/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
8.3%
4/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.4%
7/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
12.5%
6/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
General disorders
Injection site reaction
|
22.3%
21/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
22.9%
11/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
General disorders
Injection site erythema
|
17.0%
16/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
16.7%
8/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
General disorders
Injection site pruritus
|
17.0%
16/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
16.7%
8/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
General disorders
Fatigue
|
10.6%
10/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
18.8%
9/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
General disorders
Injection site pain
|
10.6%
10/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
14.6%
7/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
General disorders
Pyrexia
|
7.4%
7/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
12.5%
6/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
General disorders
Injection site induration
|
8.5%
8/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
6.2%
3/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
General disorders
Injection site oedema
|
7.4%
7/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
8.3%
4/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
General disorders
Influenza like illness
|
6.4%
6/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
8.3%
4/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
General disorders
Injection site swelling
|
5.3%
5/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
2.1%
1/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
General disorders
Oedema peripheral
|
0.00%
0/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
8.3%
4/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
55.3%
52/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
22.9%
11/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.3%
4/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
8.3%
4/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.3%
5/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
2.1%
1/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
Infections and infestations
Upper respiratory tract infection
|
16.0%
15/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
14.6%
7/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
Infections and infestations
COVID-19
|
11.7%
11/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
10.4%
5/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
Infections and infestations
Nasopharyngitis
|
8.5%
8/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
14.6%
7/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
Infections and infestations
Influenza
|
6.4%
6/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
10.4%
5/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
Infections and infestations
Sinusitis
|
3.2%
3/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
14.6%
7/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
Infections and infestations
Gastroenteritis
|
7.4%
7/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
4.2%
2/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
Infections and infestations
Pneumonia
|
4.3%
4/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
6.2%
3/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
Infections and infestations
Urinary tract infection
|
4.3%
4/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
6.2%
3/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
Infections and infestations
Viral rhinitis
|
5.3%
5/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
4.2%
2/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
Infections and infestations
Otitis media
|
5.3%
5/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
2.1%
1/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
Infections and infestations
Conjunctivitis
|
2.1%
2/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
6.2%
3/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
Infections and infestations
Ear infection
|
5.3%
5/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
0.00%
0/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
Infections and infestations
Gastroenteritis viral
|
1.1%
1/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
6.2%
3/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
Nervous system disorders
Headache
|
36.2%
34/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
37.5%
18/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
Nervous system disorders
Dizziness
|
11.7%
11/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
8.3%
4/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
Investigations
Blood creatine phosphokinase increased
|
2.1%
2/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
8.3%
4/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
Investigations
Alanine aminotransferase increased
|
5.3%
5/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
0.00%
0/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
Psychiatric disorders
Depressive symptom
|
6.4%
6/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
10.4%
5/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
Psychiatric disorders
Depression
|
5.3%
5/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
6.2%
3/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.7%
11/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
14.6%
7/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
9.6%
9/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
6.2%
3/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.3%
4/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
12.5%
6/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.4%
7/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
4.2%
2/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.3%
4/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
8.3%
4/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.3%
4/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
8.3%
4/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.4%
6/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
2.1%
1/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
10.6%
10/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
2.1%
1/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.4%
6/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
2.1%
1/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
5.3%
5/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
0.00%
0/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
16.0%
15/94 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
6.2%
3/48 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
|
Reproductive system and breast disorders
Erection increased
|
10.0%
4/40 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
17.6%
3/17 • Baseline up to Week 62
Safety analysis set included all participants who received at least 1 dose of study treatment (placebo or setmelanotide). 'All-cause mortality' data was reported for all randomized participants and includes participants on study drug bridging visits beyond the primary analysis of the double-blind period.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place