Trial Outcomes & Findings for Setmelanotide for the Treatment of Leptin Receptor (LEPR) Deficiency Obesity (NCT NCT03287960)
NCT ID: NCT03287960
Last Updated: 2023-05-23
Results Overview
The percentage of participants who met the ≥10% weight loss threshold (responders) after approximately Week 52 (\~1 year) of treatment were analyzed.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
15 participants
Primary outcome timeframe
Week 52
Results posted on
2023-05-23
Participant Flow
Participants were enrolled into the pivotal cohort (11 participants) or supplemental cohort (4 participants). Pivotal cohort: Set of participants under study constituted a collection of detailed clinical case reports with a comprehensive baseline and past medical history assessment and complete clinical efficacy, safety and laboratory evaluations conducted for each participant. Supplemental cohort: Any additional participants enrolled were included in supplemental cohort.
At screening, a blood sample was obtained for genotyping for mechanisms considered to be possibly related to the safety or efficacy response to the study medication (e.g., other obesity related genes). Complete physical, relevant bloodwork and other standard assessments were performed.
Participant milestones
| Measure |
Setmelanotide
Participants received titrated doses of setmelanotide once daily, by subcutaneous (SC) injection during titration period for 2 - 12 weeks. Thereafter, participants continued setmelanotide at their specific therapeutic dose for an additional 10 weeks during the open label treatment period. Participants who achieved at least a 5 kg weight loss (or at least 5% weight loss if baseline body weight was \<100 kg) at the end of the open label treatment period, continued into the 8-week double-blind withdrawal period and received 4 weeks setmelanotide and 4 weeks placebo. Following the withdrawal period, participants entered open label treatment period and received setmelanotide to complete approximately 52 weeks (\~1 year) of treatment at a therapeutic dose.
|
|---|---|
|
Titration Period (2 to 12 Weeks)
STARTED
|
15
|
|
Titration Period (2 to 12 Weeks)
COMPLETED
|
15
|
|
Titration Period (2 to 12 Weeks)
NOT COMPLETED
|
0
|
|
Open-Label Period (10 Weeks)
STARTED
|
15
|
|
Open-Label Period (10 Weeks)
COMPLETED
|
14
|
|
Open-Label Period (10 Weeks)
NOT COMPLETED
|
1
|
|
Double-Blind Withdrawal Period (8 Weeks)
STARTED
|
14
|
|
Double-Blind Withdrawal Period (8 Weeks)
COMPLETED
|
14
|
|
Double-Blind Withdrawal Period (8 Weeks)
NOT COMPLETED
|
0
|
|
Open-Label Period (32 Weeks)
STARTED
|
14
|
|
Open-Label Period (32 Weeks)
COMPLETED
|
13
|
|
Open-Label Period (32 Weeks)
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Setmelanotide
Participants received titrated doses of setmelanotide once daily, by subcutaneous (SC) injection during titration period for 2 - 12 weeks. Thereafter, participants continued setmelanotide at their specific therapeutic dose for an additional 10 weeks during the open label treatment period. Participants who achieved at least a 5 kg weight loss (or at least 5% weight loss if baseline body weight was \<100 kg) at the end of the open label treatment period, continued into the 8-week double-blind withdrawal period and received 4 weeks setmelanotide and 4 weeks placebo. Following the withdrawal period, participants entered open label treatment period and received setmelanotide to complete approximately 52 weeks (\~1 year) of treatment at a therapeutic dose.
|
|---|---|
|
Open-Label Period (10 Weeks)
Adverse Event
|
1
|
|
Open-Label Period (32 Weeks)
Serious Adverse Event
|
1
|
Baseline Characteristics
Setmelanotide for the Treatment of Leptin Receptor (LEPR) Deficiency Obesity
Baseline characteristics by cohort
| Measure |
Setmelanotide
n=15 Participants
Participants received titrated doses of setmelanotide once daily, by SC injection during titration period for 2 - 12 weeks. Thereafter, participants continued setmelanotide at their specific therapeutic dose for an additional 10 weeks during the open label treatment period. Participants who achieved at least a 5 kg weight loss (or at least 5% weight loss if baseline body weight was \<100 kg) at the end of the open label treatment period, continued into the 8-week double-blind withdrawal period and received 4 weeks setmelanotide and 4 weeks placebo. Following the withdrawal period, participants entered open label treatment period and received setmelanotide to complete approximately 52 weeks (\~1 year) of treatment at a therapeutic dose.
|
|---|---|
|
Age, Categorical
<=18 years
|
5 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
|
Age, Continuous
|
21.67 years
STANDARD_DEVIATION 8.52 • n=39 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=39 Participants
|
|
Region of Enrollment
Netherlands
|
3 Participants
n=39 Participants
|
|
Region of Enrollment
United Kingdom
|
1 Participants
n=39 Participants
|
|
Region of Enrollment
France
|
6 Participants
n=39 Participants
|
|
Region of Enrollment
Germany
|
4 Participants
n=39 Participants
|
|
Region of Enrollment
Canada
|
1 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Week 52Population: The full analysis set (FAS) consisted of participants who received any of the study drug injections and at least one baseline assessment (included those who did and did not demonstrate ≥5 kg weight loss or 5% of body weight if weight is \<100 kg at baseline over the initial12-week open label treatment period and proceeded into the double blind, placebo-controlled withdrawal period). Participants in pivotal cohort were included in the analysis.
The percentage of participants who met the ≥10% weight loss threshold (responders) after approximately Week 52 (\~1 year) of treatment were analyzed.
Outcome measures
| Measure |
Setmelanotide (Entire Study)
n=11 Participants
Participants received setmelanotide once daily by SC injection for approximately 52 weeks (\~ 1 year).
|
|---|---|
|
Percentage of Participants Who Reached ≥10% Weight Loss Threshold After 1 Year (Pivotal Cohort)
|
45.5 percentage of participants
Interval 19.96 to 72.88
|
SECONDARY outcome
Timeframe: Week 52Population: FAS Population. Participants in pivotal and supplemental cohort were included in the analysis.
The percentage of participants who met the ≥10% weight loss threshold (responders) after approximately Week 52 (\~1 year) of treatment were analyzed.
Outcome measures
| Measure |
Setmelanotide (Entire Study)
n=15 Participants
Participants received setmelanotide once daily by SC injection for approximately 52 weeks (\~ 1 year).
|
|---|---|
|
Percentage of Participants Who Reached ≥10% Weight Loss Threshold After 1 Year (Pivotal + Supplemental Cohort)
|
53.3 percentage of participants
Interval 30.0 to 75.63
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: The Designated Use Set (DUS) consisted of participants who received any of the study drug injections, demonstrated ≥5 kg weight loss \[or 5% of body weight if weight was \<100 kg at baseline\] during the initial 12-week open label treatment period, and proceeded into the double-blind, placebo-controlled withdrawal period. Participants in pivotal and supplemental cohort were included in the analysis.
The mean percent change from baseline in body weight at 52 weeks was analyzed.
Outcome measures
| Measure |
Setmelanotide (Entire Study)
n=10 Participants
Participants received setmelanotide once daily by SC injection for approximately 52 weeks (\~ 1 year).
|
|---|---|
|
Mean Percent Change From Baseline in Body Weight
|
-12.34 Percent change
Standard Deviation 7.534
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: DUS Population. Participants in pivotal and supplemental cohort were included in the analysis.
The mean percent change in hunger scores for participants ≥12 years of age with leptin receptor (LEPR) deficiency obesity in treatment with setmelanotide was evaluated. Hunger score ranged from 0 - 10 on a Likert-type scale; 0 = not hungry at all and 10 = hungriest possible. On the Daily Hunger Questionnaire, each of the 3 items (average hunger, most/worst hunger, and morning hunger) was scored separately and averaged on a weekly basis.
Outcome measures
| Measure |
Setmelanotide (Entire Study)
n=10 Participants
Participants received setmelanotide once daily by SC injection for approximately 52 weeks (\~ 1 year).
|
|---|---|
|
Mean Percent Change From Baseline in Hunger Score ('Most Hunger')
|
-42.7 Percent Change
Standard Deviation 27.49
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: FAS population with available data at specified time point. Participants in pivotal and supplemental cohort were included in the analysis.
The percentage of participants (≥12 years of age) achieving a ≥25% improvement from baseline in hunger score at Week 52 (i.e., after treatment with setmelanotide for 52 weeks at the therapeutic dose) was assessed. Hunger ranged from 0 - 10 on a Likert-type scale; 0 = not hungry at all and 10 = hungriest possible. On the Daily Hunger Questionnaire, each of the 3 items (average hunger, most/worst hunger, and morning hunger) was scored separately and averaged on a weekly basis.
Outcome measures
| Measure |
Setmelanotide (Entire Study)
n=14 Participants
Participants received setmelanotide once daily by SC injection for approximately 52 weeks (\~ 1 year).
|
|---|---|
|
Percentage of Participants Achieving at Least 25% Improvement in Daily Hunger From Baseline
|
71.4 percentage of participants
Interval 46.0 to 89.6
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: DUS population with available data at specified time point. Participants in pivotal and supplemental cohort were included in the analysis.
Waist circumference (cm) was measured according to the National Heart, Lung, and Blood Institute (NHLBI) criteria. Waist circumference was measured when participants were fasting at approximately the same time at each visit. The absolute change from baseline in waist circumference was assessed.
Outcome measures
| Measure |
Setmelanotide (Entire Study)
n=10 Participants
Participants received setmelanotide once daily by SC injection for approximately 52 weeks (\~ 1 year).
|
|---|---|
|
Absolute Change From Baseline in Waist Circumference
Baseline
|
131.58 Centimeter
Standard Deviation 24.047
|
|
Absolute Change From Baseline in Waist Circumference
Change at Week 52
|
-9.80 Centimeter
Standard Deviation 6.095
|
SECONDARY outcome
Timeframe: Baseline and Week 8 of withdrawal periodPopulation: DUS population with available data at specified time point. Participants in pivotal and supplemental cohort were included in the analysis.
A comparison of weight change was evaluated during the 8 week placebo-controlled withdrawal period for each participant, during which each participant received 4 weeks of placebo and 4 weeks active therapy in a blinded fashion.
Outcome measures
| Measure |
Setmelanotide (Entire Study)
n=9 Participants
Participants received setmelanotide once daily by SC injection for approximately 52 weeks (\~ 1 year).
|
|---|---|
|
Absolute Change in Body Weight (Reversal of Weight Loss) During Double-Blind Placebo-Controlled Withdrawal Period
Change at Week 4: Setmelanotide
|
-1.2 Kilogram
Standard Deviation 3.04
|
|
Absolute Change in Body Weight (Reversal of Weight Loss) During Double-Blind Placebo-Controlled Withdrawal Period
Change at Week 4: Placebo
|
4.9 Kilogram
Standard Deviation 2.82
|
SECONDARY outcome
Timeframe: Week 8 of withdrawal periodPopulation: DUS population with available data at specified time point. Participants in pivotal and supplemental cohort were included in the analysis.
The absolute score in daily hunger reduction during the double-blind placebo-controlled withdrawal period (≥12 Years of Age) was assessed. Hunger ranged from 0 - 10 on a Likert-type scale; 0 = not hungry at all and 10 = hungriest possible. On the Daily Hunger Questionnaire, each of the 3 items (average hunger, most/worst hunger, and morning hunger) was scored separately and averaged on a weekly basis. The weekly average hunger score of the daily worst (most) hunger score in 24 hours is the hunger score used to assess this study endpoint. Lower scores represent lower hunger, higher scores represent greater hunger.
Outcome measures
| Measure |
Setmelanotide (Entire Study)
n=9 Participants
Participants received setmelanotide once daily by SC injection for approximately 52 weeks (\~ 1 year).
|
|---|---|
|
Absolute Daily Hunger Reduction Score During the Double-Blind Placebo-Controlled Withdrawal Period
Setmelanotide
|
3.4 units on a scale
Standard Deviation 1.63
|
|
Absolute Daily Hunger Reduction Score During the Double-Blind Placebo-Controlled Withdrawal Period
Placebo
|
6.3 units on a scale
Standard Deviation 2.13
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: DUS population with available data at specified time point. Participants in pivotal and supplemental cohort were included in the analysis.
The mean percent change from baseline in body mass index (BMI) was assessed.
Outcome measures
| Measure |
Setmelanotide (Entire Study)
n=7 Participants
Participants received setmelanotide once daily by SC injection for approximately 52 weeks (\~ 1 year).
|
|---|---|
|
Mean Percent Change From Baseline in Body Mass Index
|
-14.24 Percent change
Standard Deviation 9.096
|
SECONDARY outcome
Timeframe: Baseline and Week 52Population: The Safety Analysis Set (SAS) was defined as all participants who received any study drug injections at least one post-dose safety assessment. Participants with available data were analyzed. Participants in pivotal and supplemental cohort were included in the analysis.
Glucose parameters included glucose, glycated hemoglobin (HbA1c) and Oral glucose tolerance test (OGTT). Data is planned to be reported only for change from baseline in glucose levels.
Outcome measures
| Measure |
Setmelanotide (Entire Study)
n=15 Participants
Participants received setmelanotide once daily by SC injection for approximately 52 weeks (\~ 1 year).
|
|---|---|
|
Change From Baseline in Glucose Parameters
Baseline
|
5.586 millimole per liter
Standard Deviation 2.3740
|
|
Change From Baseline in Glucose Parameters
Change at Week 52
|
-0.465 millimole per liter
Standard Deviation 1.4350
|
Adverse Events
Setmelanotide
Serious events: 3 serious events
Other events: 15 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Setmelanotide
n=15 participants at risk
Participants received titrated doses of setmelanotide once daily, by SC injection during titration period for 2 - 12 weeks. Thereafter, participants continued setmelanotide at their specific therapeutic dose for an additional 10 weeks during the open label treatment period. Participants who achieved at least a 5 kg weight loss (or at least 5% weight loss if baseline body weight was \<100 kg) at the end of the open label treatment period, continued into the 8-week double-blind withdrawal period and received 4 weeks setmelanotide and 4 weeks placebo. Following the withdrawal period, participants entered open label treatment period and received setmelanotide to complete approximately 52 weeks (\~1 year) of treatment at a therapeutic dose.
|
|---|---|
|
Hepatobiliary disorders
Cholecystitis
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Psychiatric disorders
Suicidal Ideation
|
6.7%
1/15 • Number of events 3 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Surgical and medical procedures
Gastric Banding Reversal
|
6.7%
1/15 • Number of events 2 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
Other adverse events
| Measure |
Setmelanotide
n=15 participants at risk
Participants received titrated doses of setmelanotide once daily, by SC injection during titration period for 2 - 12 weeks. Thereafter, participants continued setmelanotide at their specific therapeutic dose for an additional 10 weeks during the open label treatment period. Participants who achieved at least a 5 kg weight loss (or at least 5% weight loss if baseline body weight was \<100 kg) at the end of the open label treatment period, continued into the 8-week double-blind withdrawal period and received 4 weeks setmelanotide and 4 weeks placebo. Following the withdrawal period, participants entered open label treatment period and received setmelanotide to complete approximately 52 weeks (\~1 year) of treatment at a therapeutic dose.
|
|---|---|
|
Vascular disorders
Flushing
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
13.3%
2/15 • Number of events 3 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Eye naevus
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
General disorders
Injection site erythema
|
73.3%
11/15 • Number of events 32 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
General disorders
Injection site induration
|
46.7%
7/15 • Number of events 16 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
General disorders
Injection site pain
|
46.7%
7/15 • Number of events 14 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
General disorders
Injection site oedema
|
40.0%
6/15 • Number of events 13 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
General disorders
Injection site pruritus
|
53.3%
8/15 • Number of events 13 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
General disorders
Fatigue
|
13.3%
2/15 • Number of events 9 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
General disorders
Injection site bruising
|
33.3%
5/15 • Number of events 8 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
General disorders
Asthenia
|
26.7%
4/15 • Number of events 7 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
General disorders
Influenza like illness
|
20.0%
3/15 • Number of events 4 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
General disorders
Injection site haematoma
|
13.3%
2/15 • Number of events 3 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
General disorders
Injection site hypersensitivity
|
20.0%
3/15 • Number of events 3 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
General disorders
Chest pain
|
6.7%
1/15 • Number of events 2 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
General disorders
Malaise
|
13.3%
2/15 • Number of events 2 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
General disorders
Injection site atrophy
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
General disorders
Injection site reaction
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
General disorders
Injection site urticaria
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
General disorders
Medical device pain
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
General disorders
Medical device site erythema
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
General disorders
Oedema
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
General disorders
Pyrexia
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
General disorders
Xerosis
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Psychiatric disorders
Insomnia
|
26.7%
4/15 • Number of events 7 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Psychiatric disorders
Anxiety
|
20.0%
3/15 • Number of events 4 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
General disorders
Depression
|
13.3%
2/15 • Number of events 4 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Psychiatric disorders
Depressed mood
|
13.3%
2/15 • Number of events 2 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
General disorders
Suicidal ideation
|
6.7%
1/15 • Number of events 2 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
General disorders
Affect lability
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Psychiatric disorders
Drug abuse
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Psychiatric disorders
Fear of injection
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Psychiatric disorders
Illusion
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
6.7%
1/15 • Number of events 5 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Reproductive system and breast disorders
Spontaneous penile erection
|
26.7%
4/15 • Number of events 5 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Reproductive system and breast disorders
Ejaculation disorder
|
6.7%
1/15 • Number of events 2 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
6.7%
1/15 • Number of events 2 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Reproductive system and breast disorders
Amenorrhoea
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
General disorders
Vaginal haemorrhage
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Injury, poisoning and procedural complications
Joint Injury
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Investigations
Alanine aminotransferase increased
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Investigations
Blood creatine phosphokinase abnormal
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Investigations
Blood follicle stimulating hormone increased
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Investigations
Blood lactate dehydrogenase increased
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Investigations
Blood luteinising hormone increased
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Investigations
Blood urea decreased
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Investigations
Blood uric acid increased
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Investigations
Heart rate increased
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Investigations
Insulin tolerance test abnormal
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Investigations
Neutrophil count increased
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Investigations
Weight increased
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Cardiac disorders
Cardiac flutter
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.7%
1/15 • Number of events 3 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Blood and lymphatic system disorders
Anemia
|
20.0%
3/15 • Number of events 3 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
6.7%
1/15 • Number of events 3 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Blood and lymphatic system disorders
Iron deficiency anemia
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Nervous system disorders
Headache
|
33.3%
5/15 • Number of events 18 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Nervous system disorders
Dizziness
|
26.7%
4/15 • Number of events 5 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Nervous system disorders
Sleep paralysis
|
6.7%
1/15 • Number of events 3 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Nervous system disorders
Presyncope
|
6.7%
1/15 • Number of events 2 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Nervous system disorders
Sciatica
|
6.7%
1/15 • Number of events 2 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Nervous system disorders
Syncope
|
6.7%
1/15 • Number of events 2 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Nervous system disorders
Migraine
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Nervous system disorders
Tic
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Ear and labyrinth disorders
Ear pain
|
6.7%
1/15 • Number of events 2 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Ear and labyrinth disorders
Tinnitus
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Ear and labyrinth disorders
Vertigo
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Gastrointestinal disorders
Nausea
|
53.3%
8/15 • Number of events 16 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
26.7%
4/15 • Number of events 13 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Gastrointestinal disorders
Diarrhea
|
46.7%
7/15 • Number of events 13 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Gastrointestinal disorders
Constipation
|
13.3%
2/15 • Number of events 3 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.7%
1/15 • Number of events 2 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Gastrointestinal disorders
Gingival discolouration
|
6.7%
1/15 • Number of events 2 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Gastrointestinal disorders
Vomiting
|
13.3%
2/15 • Number of events 2 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Gastrointestinal disorders
Abdominal distension
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Gastrointestinal disorders
Haemorrhoids
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Hepatobiliary disorders
Cholestasis
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Hepatobiliary disorders
Hepatocellular injury
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Renal and urinary disorders
Haematuria
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Renal and urinary disorders
Proteinuria
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Renal and urinary disorders
Renal colic
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Renal and urinary disorders
Renal failure
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
73.3%
11/15 • Number of events 20 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
13.3%
2/15 • Number of events 3 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
13.3%
2/15 • Number of events 2 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Skin and subcutaneous tissue disorders
Skin striae
|
6.7%
1/15 • Number of events 2 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
6.7%
1/15 • Number of events 2 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Skin and subcutaneous tissue disorders
Hair growth rate abnormal
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Skin and subcutaneous tissue disorders
Lentigo
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Skin and subcutaneous tissue disorders
Lipodystrophy acquired
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Skin and subcutaneous tissue disorders
Melanocytic naevus
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Skin and subcutaneous tissue disorders
Pigmentation disorder
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
26.7%
4/15 • Number of events 7 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
26.7%
4/15 • Number of events 4 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
6.7%
1/15 • Number of events 4 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
20.0%
3/15 • Number of events 3 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Endocrine disorders
Hypothyroidism
|
13.3%
2/15 • Number of events 2 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Endocrine disorders
Hypogonadism
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.7%
1/15 • Number of events 2 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Metabolism and nutrition disorders
Folate deficiency
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Metabolism and nutrition disorders
Gout
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Metabolism and nutrition disorders
Vitamin A deficiency
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Infections and infestations
Lower respiratory tract infection
|
6.7%
1/15 • Number of events 6 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Infections and infestations
Nasopharyngitis
|
26.7%
4/15 • Number of events 6 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Infections and infestations
Gastrointestinal infection
|
13.3%
2/15 • Number of events 2 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Infections and infestations
Influenza
|
6.7%
1/15 • Number of events 2 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Infections and infestations
Pharyngitis
|
13.3%
2/15 • Number of events 2 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Infections and infestations
Rhinitis
|
13.3%
2/15 • Number of events 2 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Infections and infestations
Arthritis viral
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Infections and infestations
Bronchitis
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Infections and infestations
Fungal infection
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Infections and infestations
Gastroenteritis
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Infections and infestations
Injection site abscess
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
|
Infections and infestations
Otitis externa
|
6.7%
1/15 • Number of events 1 • From first dose up to ~30 days after last dose of study drug (Up to ~ 1 year)
SAS population. Participants in pivotal and supplemental cohort were included. Adverse events were analyzed for participants in placebo \& setmelanotide groups combined as one group per planned analysis.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee All information regarding setmelanotide supplied by Rhythm to the investigator is privileged and confidential information. The investigator agrees to use this information to accomplish the study and will not use it for other purposes without consent from Rhythm. The information obtained from the clinical study will be used towards the development of setmelanotide and may be disclosed to regulatory authority(ies), other investigators, corporate partners, or consultants as required.
- Publication restrictions are in place
Restriction type: OTHER