Trial Outcomes & Findings for Setmelanotide for the Treatment of Early-Onset Pro-Opiomelanocortin (POMC) Deficiency Obesity (NCT NCT02896192)
NCT ID: NCT02896192
Last Updated: 2023-09-21
Results Overview
The percentage of participants who met the ≥ 10% weight loss threshold 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
2023-09-21
Participant Flow
Participants were enrolled into the pivotal cohort (10 participants) or supplemental cohort (5 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 kilograms (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.
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|---|---|
|
Titration Period (2 to 12 Weeks)
STARTED
|
15
|
|
Titration Period (2 to 12 Weeks)
Treated
|
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
|
13
|
|
Open-Label Period (10 Weeks)
NOT COMPLETED
|
2
|
|
Double-Blind Withdrawal Period (8 Weeks)
STARTED
|
13
|
|
Double-Blind Withdrawal Period (8 Weeks)
COMPLETED
|
13
|
|
Double-Blind Withdrawal Period (8 Weeks)
NOT COMPLETED
|
0
|
|
Open-Label Period (32 Weeks)
STARTED
|
13
|
|
Open-Label Period (32 Weeks)
COMPLETED
|
12
|
|
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 kilograms (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.
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|---|---|
|
Open-Label Period (10 Weeks)
Lack of Efficacy
|
1
|
|
Open-Label Period (10 Weeks)
Protocol Violation
|
1
|
|
Open-Label Period (32 Weeks)
Lost to Follow-up
|
1
|
Baseline Characteristics
Setmelanotide for the Treatment of Early-Onset Pro-Opiomelanocortin (POMC) 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.
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|---|---|
|
Age, Continuous
|
17.20 years
STANDARD_DEVIATION 7.02 • n=5 Participants
|
|
Age, Customized
< 12 years
|
5 Participants
n=5 Participants
|
|
Age, Customized
≥ 12 years
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 52Population: Full Analysis Set (FAS) population included participants who received any of the study drug injections and had at least one baseline assessment (included those who did and did not demonstrate ≥ 5 kg weight loss or 5% of body weight if weight was \< 100 kg at baseline over the 12-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 after approximately Week 52 (\~1 year) of treatment were analyzed.
Outcome measures
| Measure |
Setmelanotide (Entire Study)
n=10 Participants
Participants received setmelanotide once daily by SC injection for approximately 52 weeks (\~ 1 year).
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|---|---|
|
Percentage of Participants Who Reached ≥10% Weight Loss Threshold After 1 Year (Pivotal Cohort)
|
80.0 percentage of participants
Interval 49.31 to 96.32
|
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 after approximately Week 52 (\~1 year) of treatment were analyzed.
Outcome measures
| Measure |
Setmelanotide (Entire Study)
n=14 Participants
Participants received setmelanotide once daily by SC injection for approximately 52 weeks (\~ 1 year).
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|---|---|
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Percentage of Participants Who Reached ≥10% Weight Loss Threshold After 1 Year (Pivotal + Supplemental Cohort)
|
85.7 percentage of participants
Interval 61.46 to 97.4
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Designated Use Set (DUS) analysis population 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 over the 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=13 Participants
Participants received setmelanotide once daily by SC injection for approximately 52 weeks (\~ 1 year).
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|---|---|
|
Mean Percent Change From Baseline in Body Weight at Week 52
|
-25.83 percent change
Standard Deviation 9.721
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Participants in the DUS population with available data were analyzed. 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. 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.
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 Hunger Score (Worst "Most" Hunger in 24 Hours) at Week 52
|
-27.1 percent change
Standard Deviation 28.11
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Participants in the FAS population with available data were analyzed. 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. 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.
Outcome measures
| Measure |
Setmelanotide (Entire Study)
n=8 Participants
Participants received setmelanotide once daily by SC injection for approximately 52 weeks (\~ 1 year).
|
|---|---|
|
Percentage of Participants Who Achieved at Least 25% Improvement in Daily Hunger From Baseline
|
50.0 percentage of participants
Interval 19.29 to 80.71
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Participants in the DUS population with available data were analyzed. Participants in pivotal and supplemental cohort were included in the analysis.
Waist circumference (centimeters) 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=13 Participants
Participants received setmelanotide once daily by SC injection for approximately 52 weeks (\~ 1 year).
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|---|---|
|
Absolute Change From Baseline in Waist Circumference at Week 52
Baseline
|
115.48 centimeters
Standard Deviation 17.920
|
|
Absolute Change From Baseline in Waist Circumference at Week 52
Change at Week 52
|
-17.51 centimeters
Standard Deviation 9.112
|
SECONDARY outcome
Timeframe: Baseline, 8-week withdrawal period (up to ~Week 20)Population: Participants in the DUS population with available data were analyzed. 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=11 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 after 4 weeks of therapy: Setmelanotide
|
-2.8 kilograms
Standard Deviation 2.41
|
|
Absolute Change in Body Weight (Reversal of Weight Loss) During Double-Blind Placebo-Controlled Withdrawal Period
Change after 4 weeks of therapy: Placebo
|
6.2 kilograms
Standard Deviation 3.87
|
SECONDARY outcome
Timeframe: 8-week withdrawal period (up to ~Week 20)Population: Participants in the DUS population with available data were analyzed. Participants in pivotal and supplemental cohort were included in the analysis.
The absolute score in daily hunger 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=7 Participants
Participants received setmelanotide once daily by SC injection for approximately 52 weeks (\~ 1 year).
|
|---|---|
|
Absolute Score in Daily Hunger Reduction During the Double-Blind Placebo-Controlled Withdrawal Period
Setmelanotide
|
4.5 units on a scale
Standard Deviation 2.57
|
|
Absolute Score in Daily Hunger Reduction During the Double-Blind Placebo-Controlled Withdrawal Period
Placebo
|
6.7 units on a scale
Standard Deviation 2.22
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Participants in the DUS population with available data were analyzed. Participants in pivotal and supplemental cohort were included in the analysis.
The mean percent change from baseline in BMI was assessed.
Outcome measures
| Measure |
Setmelanotide (Entire Study)
n=11 Participants
Participants received setmelanotide once daily by SC injection for approximately 52 weeks (\~ 1 year).
|
|---|---|
|
Mean Percent Change From Baseline in Body Mass Index (BMI) at Week 52
|
-27.32 percent change
Standard Deviation 8.971
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Participants in the SAS population with available data were analyzed. Participants in pivotal and supplemental cohort were included in the analysis.
The AUC change from baseline for the OGTT was assessed. The AUC was calculated by the linear trapezoidal method and includes pre-dose and post-dose assessments. At each visit, oral glucose was captured pre-meal, and post-meal at the following times: 30 minutes, 60 minutes, 90 minutes, and 120 minutes. OGTT was not performed for participants with a diagnosis of Type 1 or Type 2 diabetes.
Outcome measures
| Measure |
Setmelanotide (Entire Study)
n=13 Participants
Participants received setmelanotide once daily by SC injection for approximately 52 weeks (\~ 1 year).
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|---|---|
|
Area Under the Curve (AUC) Change From Baseline in Oral Glucose, Assessed by the Oral Glucose Tolerance Test (OGTT)
Change at Week 52
|
-35.284 minutes*millimoles/liter (min*mmol/L)
Standard Deviation 442.6334
|
|
Area Under the Curve (AUC) Change From Baseline in Oral Glucose, Assessed by the Oral Glucose Tolerance Test (OGTT)
Baseline
|
951.900 minutes*millimoles/liter (min*mmol/L)
Standard Deviation 464.9342
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Participants in the SAS population with available data were analyzed. Participants in pivotal and supplemental cohort were included in the analysis.
Change from baseline in serum glucose at Week 52 was assessed.
Outcome measures
| Measure |
Setmelanotide (Entire Study)
n=15 Participants
Participants received setmelanotide once daily by SC injection for approximately 52 weeks (\~ 1 year).
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|---|---|
|
Change From Baseline in Serum Glucose at Week 52
Baseline
|
6.606 mmol/L
Standard Deviation 5.0024
|
|
Change From Baseline in Serum Glucose at Week 52
Change at Week 52
|
-1.527 mmol/L
Standard Deviation 1.9374
|
Adverse Events
Setmelanotide
Serious events: 6 serious events
Other events: 15 other events
Deaths: 0 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.
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|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Psychiatric disorders
Depression
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Psychiatric disorders
Major Depression
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Psychiatric disorders
Panic Attack
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Endocrine disorders
Adrenocortical Insufficiency Acute
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Infections and infestations
Pneumonia
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
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
Haematoma
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic Naevus
|
40.0%
6/15 • 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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Immune system disorders
Multiple Allergies
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
General disorders
Injection Site Erythema
|
80.0%
12/15 • Number of events 59 • 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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
General disorders
Injection Site Oedema
|
60.0%
9/15 • Number of events 29 • 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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
General disorders
Injection Site Pruritus
|
60.0%
9/15 • 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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
General disorders
Fatigue
|
40.0%
6/15 • 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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
General disorders
Chills
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
General disorders
Injection Site Pain
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
General disorders
Asthenia
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
General disorders
Injection Site Bruising
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
General disorders
Pyrexia
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
General disorders
Injection Site Induration
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
General disorders
Hyperthermia
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
General disorders
Injection Site Discolouration
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
General disorders
Injection Site Nodule
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
General disorders
Temperature Intolerance
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
General disorders
Thirst
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Psychiatric disorders
Suicidal Ideation
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Psychiatric disorders
Restlessness
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Psychiatric disorders
Sleep Disorder
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Psychiatric disorders
Depression
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Psychiatric disorders
Irritability
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Psychiatric disorders
Nightmare
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Reproductive system and breast disorders
Spontaneous Penile Erection
|
13.3%
2/15 • 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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Reproductive system and breast disorders
Erection 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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Injury, poisoning and procedural complications
Accidental Overdose
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Investigations
Blood Bilirubin 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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Investigations
Blood Potassium 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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Investigations
Blood Thyroid 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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Investigations
International Normalised Ratio 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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Cardiac disorders
Bradycardia
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Cardiac disorders
Sinus Bradycardia
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Blood and lymphatic system disorders
Iron Deficiency Anaemia
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal 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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Nervous system disorders
Headache
|
53.3%
8/15 • 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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Nervous system disorders
Disturbance in Attention
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Nervous system disorders
Dizziness
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Nervous system disorders
Parosmia
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Nervous system disorders
Sciatica
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Nervous system disorders
Syncope
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Ear and labyrinth disorders
Vertigo
|
20.0%
3/15 • 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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Gastrointestinal disorders
Nausea
|
53.3%
8/15 • 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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Gastrointestinal disorders
Vomiting
|
53.3%
8/15 • Number of events 17 • 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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Gastrointestinal disorders
Abdominal Pain
|
26.7%
4/15 • Number of events 10 • 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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
5/15 • 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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Gastrointestinal disorders
Dry Mouth
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Gastrointestinal disorders
Lip Dry
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Gastrointestinal disorders
Constipation
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Hepatobiliary disorders
Cholelithiasis
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Renal and urinary disorders
Leukocyturia
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Skin and subcutaneous tissue disorders
Skin Hyperpigmentation
|
100.0%
15/15 • Number of events 24 • 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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Skin and subcutaneous tissue disorders
Rash Papular
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Skin and subcutaneous tissue disorders
Perioral Dermatitis
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Skin and subcutaneous tissue disorders
Rash Erythematous
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Skin and subcutaneous tissue disorders
Skin Hypopigmentation
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Musculoskeletal and connective tissue disorders
Muscle Contracture
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Endocrine disorders
Cortisol 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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Metabolism and nutrition disorders
Hypovitaminosis
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Metabolism and nutrition disorders
Selenium 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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Metabolism and nutrition disorders
Vitamin D 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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Infections and infestations
Nasopharyngitis
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Infections and infestations
Pharyngitis
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Infections and infestations
Pharyngitis Streptococcal
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Infections and infestations
Tonsillitis
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Infections and infestations
Viral 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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
|
Gastrointestinal disorders
Gastritis
|
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 the setmelanotide group (including the placebo withdrawal period) and adverse event data were not collected separately by period (or during placebo withdrawal) since all participants were exposed to setmelanotide.
|
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