Genetic Obesity, Obesity, Obesity Due to Melanocortin 4 Receptor Deficiency
Conditions
Keywords
Pro-opiomelanocortin (POMC) deficiency obesity, LepR deficiency obesity, Smith-Magenis Syndrome, MC4R deficiency obesity, SRC1 deficiency obesity, SH2B1 deficiency obesity
Brief summary
The purpose of the study was to determine the effect of setmelanotide (RM-493) on weight, hunger assessments, and other factors in participants with rare genetic disorders of obesity.
Interventions
DRUGSetmelanotide
RM-493 QD SC injection
Sponsors
Rhythm Pharmaceuticals, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Participants with the following genotypes and/or clinical assessment: 1. POMC/PCSK1/LEPR heterozygous - not currently enrolling new participants 2. POMC/PCSK1/LEPR compound heterozygous (two different mutations in gene) or homozygous deficiency obesity 3. POMC/PCSK1/LEPR composite heterozygous (two or more mutations in two or more genes) deficiency obesity 4. SMS 5. SH2B1 deficiency obesity 6. Chromosomal rearrangement of the 16p11.2 locus causing obesity 7. Carboxypeptidase E (CPE) compound heterozygous or homozygous deficiency obesity 8. Leptin deficiency obesity with loss of response to metreleptin 9. SRC1 deficiency obesity 10. MC4R deficiency obesity 2. Age 6 years and above 3. Obese, defined as Body Mass Index (BMI) ≥ 30 kilogram per meter square (kg/m\^2) for participants ≥16 years of age or BMI≥ 95th percentile for age and gender for participants 6 up to 16 years of age. 4. Participant and/or parent or guardian is able to understand and comply with the requirements of the study and is able to understand and sign the written informed consent/assent 5. Female participants of childbearing potential must be confirmed non-pregnant, and agree to use contraception as outlined in the protocol. 6. Male participants with female partners of childbearing potential must agree to a double barrier method if they become sexually active during the study. Male participants must not donate sperm during and for 90 days following their participation in the study. Key
Exclusion criteria
1. Recent intensive (within 2 months) diet and/or exercise regimen with or without the use of weight loss agents that has resulted in \> 2% weight loss. 2. Use of any medication that is approved to treat obesity within three months of first dose of study drug (e.g., orlistat, lorcaserin, phentermine-topiramate, naltrexone-bupropion). 3. Gastric bypass surgery within the previous six months or any prior gastric bypass surgery resulting in \>10% weight loss durably maintained 4. Diagnosis of schizophrenia, bipolar disorder, personality disorder, major depressive disorder, or other psychiatric disorder(s) 5. Suicidal ideation, attempt or behavior 6. Clinically significant pulmonary, cardiac, or oncologic disease 7. hemoglobin A1c (HbA1c) \> 9.0% at Screening 8. History of significant liver disease 9. Glomerular filtration rate (GFR) \< 30 milliliter/minute (mL/min) at Screening. 10. History or close family history of melanoma or participant history of oculocutaneous albinism 11. Significant dermatologic findings relating to melanoma or pre-melanoma skin lesions. 12. Participation in any clinical study with an investigational drug/device within 3 months prior to the first day of dosing. 13. Participants previously enrolled in a clinical study involving setmelanotide or any previous exposure to setmelanotide. 14. Inability to comply with QD injection regimen. 15. Females who are breastfeeding or nursing. Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With ≥ 5% Reduction in Body Weight From Baseline After 3 Months of Setmelanotide Treatment | Baseline to Month 3 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Body Weight After 3 Months of Setmelanotide Treatment | Baseline, Month 3 | — |
| Percent Change From Baseline in Body Weight After 3 Months of Setmelanotide Treatment | Baseline, Month 3 | — |
| Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Baseline, Month 3 | The mean change in daily hunger questionnaire scores for participants ≥ 12 years of age with obesity in treatment with setmelanotide was evaluated. On the Daily Hunger Questionnaire, each of the 3 items (average hunger in the last 24 hours, most/worst hunger in the last 24 hours, and morning hunger) was assessed daily and scored separately using a numeric rating score for each from 0 to 10, with 0 = not hungry at all and 10 = hungriest possible. |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | From first dose up to Month 16 | An adverse event (AE) was any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE (also referred to as an adverse experience) could be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality. TEAEs were defined as AEs reported after dosing on Day 1. |
| Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Baseline, Month 3 | For participants ≥ 12 years of age, the following question was asked using the Global Hunger Questionnaire: Overall, how would you rate the hunger you experience now? Possible responses were: No hunger; Mild hunger; Moderate hunger; Severe hunger; and Not answered. |
| Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Baseline, Month 3 | For participants \< 12 years of age, the following question was asked to parents or caregivers of participants using the Global Hunger Questionnaire: How hungry is your child acting now? Possible responses were: Not hungry at all; A little hungry; Moderately hungry; Extremely hungry; and Not answered. |
| Percent Change From Baseline in Waist Circumference After 3 Months of Setmelanotide Treatment | Baseline, Month 3 | Waist circumference (cm) was measured according to the National Heart, Lung, and Blood Institute (NHLBI) criteria. All measurements were single measures. Waist circumference was measured when participants were in fasting condition and at approximately the same time at each visit. |
| Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Baseline, Month 3 | The mean change in daily hunger questionnaire scores for participants \< 12 years of age with obesity in treatment with setmelanotide was evaluated. Hunger was assessed daily using a Daily Hunger Questionnaire with a pictorial (smiley face) version of the Likert rating scale with scores ranged from 0 to 4, with 0 = not hungry at all and 4 = hungriest possible. |
Countries
Canada, France, Germany, Greece, Israel, Netherlands, Spain, United Kingdom, United States
Participant flow
Recruitment details
Of the 218 participants screened, 213 participants were enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| 16p11.2 Cohort Participants with chromosomal rearrangement of the 16p11.2 locus causing obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months. | 19 |
| AS Cohort Participants with AS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months. | 4 |
| BBS Cohort Participants with BBS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months. | 10 |
| MC4R Cohort Participants with MC4R deficiency obesity received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months. | 49 |
| POMC/PCSK1/LEPR Heterozygous Cohort Participants with PCSK1/LEPR heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months. | 33 |
| POMC/PCSK1/LEPR Composite Heterozygous Cohort Participants with POMC/PCSK1/LEPR composite heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months. | 5 |
| POMC/PCSK1/LEPR Compound Heterozygous Cohort Participants with POMC/PCSK1/LEPR compound heterozygous mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months. | 27 |
| SH2B1 Cohort Participants with SH2B1 haploinsufficiency received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months. | 22 |
| SMS Cohort Participants with SMS received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months. | 12 |
| SRC1 Cohort Participants with SRC1 mutations received setmelanotide QD via SC injection for 16 weeks. All participants initiated treatment with setmelanotide (starting dose being age dependent) and the dose was escalated up to a maximum dose of 3.0 mg QD. Participants either continued setmelanotide treatment by enrolling in an extension study (RM-493-022; NCT03651765) immediately following the last dose in this study or if the extension study was not open at the current clinic site, participants continued treatment in the current study for up to 1 year, resulting in treatment duration of up to 16 months. | 32 |
| Total | 213 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 3 | 2 | 1 | 3 | 8 | 0 | 2 |
| Overall Study | Death | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Lack of Efficacy | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Lost to Follow-up | 0 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 2 |
| Overall Study | Non-Compliance With Study Drug | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Other | 0 | 0 | 2 | 0 | 2 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Physician Decision | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Protocol Violation | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Withdrawal By Parent/Guardian | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 2 | 0 | 5 | 6 | 2 | 3 | 1 | 0 | 4 |
Baseline characteristics
| Characteristic | Total | 16p11.2 Cohort | AS Cohort | BBS Cohort | MC4R Cohort | POMC/PCSK1/LEPR Heterozygous Cohort | POMC/PCSK1/LEPR Composite Heterozygous Cohort | POMC/PCSK1/LEPR Compound Heterozygous Cohort | SH2B1 Cohort | SMS Cohort | SRC1 Cohort |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 28.1 years STANDARD_DEVIATION 17.3 | 21.4 years STANDARD_DEVIATION 14.58 | 16.0 years STANDARD_DEVIATION 3.74 | 22.5 years STANDARD_DEVIATION 14.71 | 22.4 years STANDARD_DEVIATION 15.28 | 36.1 years STANDARD_DEVIATION 17.23 | 40.4 years STANDARD_DEVIATION 19.62 | 30.7 years STANDARD_DEVIATION 20.16 | 33.6 years STANDARD_DEVIATION 17.88 | 19.4 years STANDARD_DEVIATION 8.1 | 31.3 years STANDARD_DEVIATION 17.13 |
| Body Weight | 122.98 kilograms (kg) STANDARD_DEVIATION 36.142 | 113.62 kilograms (kg) STANDARD_DEVIATION 38.489 | 87.28 kilograms (kg) STANDARD_DEVIATION 16.36 | 128.04 kilograms (kg) STANDARD_DEVIATION 28.631 | 117.87 kilograms (kg) STANDARD_DEVIATION 32.339 | 143.04 kilograms (kg) STANDARD_DEVIATION 30.492 | 139.05 kilograms (kg) STANDARD_DEVIATION 30.957 | 122.08 kilograms (kg) STANDARD_DEVIATION 43.315 | 129.06 kilograms (kg) STANDARD_DEVIATION 39.48 | 92.48 kilograms (kg) STANDARD_DEVIATION 24.556 | 124.07 kilograms (kg) STANDARD_DEVIATION 33.717 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 14 Participants | 1 Participants | 0 Participants | 1 Participants | 3 Participants | 2 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 184 Participants | 13 Participants | 4 Participants | 8 Participants | 40 Participants | 31 Participants | 5 Participants | 25 Participants | 19 Participants | 10 Participants | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 15 Participants | 5 Participants | 0 Participants | 1 Participants | 6 Participants | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 23 Participants | 0 Participants | 1 Participants | 1 Participants | 3 Participants | 5 Participants | 1 Participants | 0 Participants | 5 Participants | 1 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 20 Participants | 4 Participants | 0 Participants | 0 Participants | 8 Participants | 0 Participants | 0 Participants | 3 Participants | 2 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 166 Participants | 15 Participants | 2 Participants | 9 Participants | 38 Participants | 28 Participants | 4 Participants | 23 Participants | 13 Participants | 10 Participants | 24 Participants |
| Sex: Female, Male Female | 143 Participants | 13 Participants | 3 Participants | 6 Participants | 27 Participants | 22 Participants | 4 Participants | 18 Participants | 15 Participants | 10 Participants | 25 Participants |
| Sex: Female, Male Male | 70 Participants | 6 Participants | 1 Participants | 4 Participants | 22 Participants | 11 Participants | 1 Participants | 9 Participants | 7 Participants | 2 Participants | 7 Participants |
| Waist Circumference | 125.63 centimeters (cm) STANDARD_DEVIATION 22.162 | 116.84 centimeters (cm) STANDARD_DEVIATION 22.179 | 109.75 centimeters (cm) STANDARD_DEVIATION 14.523 | 126.20 centimeters (cm) STANDARD_DEVIATION 19.344 | 122.52 centimeters (cm) STANDARD_DEVIATION 19.697 | 137.95 centimeters (cm) STANDARD_DEVIATION 18.529 | 134.00 centimeters (cm) STANDARD_DEVIATION 19.038 | 128.52 centimeters (cm) STANDARD_DEVIATION 28.772 | 130.28 centimeters (cm) STANDARD_DEVIATION 23.029 | 110.14 centimeters (cm) STANDARD_DEVIATION 11.807 | 123.10 centimeters (cm) STANDARD_DEVIATION 21.101 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 4 | 0 / 10 | 1 / 49 | 0 / 33 | 0 / 5 | 0 / 27 | 0 / 22 | 0 / 12 | 0 / 32 |
| other Total, other adverse events | 19 / 19 | 4 / 4 | 10 / 10 | 48 / 49 | 33 / 33 | 5 / 5 | 27 / 27 | 21 / 22 | 12 / 12 | 29 / 32 |
| serious Total, serious adverse events | 1 / 19 | 0 / 4 | 1 / 10 | 1 / 49 | 1 / 33 | 1 / 5 | 2 / 27 | 0 / 22 | 0 / 12 | 0 / 32 |
Outcome results
Primary
Number of Participants With ≥ 5% Reduction in Body Weight From Baseline After 3 Months of Setmelanotide Treatment
Time frame: Baseline to Month 3
Population: Participants in the FAS were analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 16p11.2 Cohort | Number of Participants With ≥ 5% Reduction in Body Weight From Baseline After 3 Months of Setmelanotide Treatment | 6 Participants |
| AS Cohort | Number of Participants With ≥ 5% Reduction in Body Weight From Baseline After 3 Months of Setmelanotide Treatment | 3 Participants |
| BBS Cohort | Number of Participants With ≥ 5% Reduction in Body Weight From Baseline After 3 Months of Setmelanotide Treatment | 7 Participants |
| MC4R Cohort | Number of Participants With ≥ 5% Reduction in Body Weight From Baseline After 3 Months of Setmelanotide Treatment | 7 Participants |
| POMC/PCSK1/LEPR Heterozygous Cohort | Number of Participants With ≥ 5% Reduction in Body Weight From Baseline After 3 Months of Setmelanotide Treatment | 10 Participants |
| POMC/PCSK1/LEPR Composite Heterozygous Cohort | Number of Participants With ≥ 5% Reduction in Body Weight From Baseline After 3 Months of Setmelanotide Treatment | 0 Participants |
| POMC/PCSK1/LEPR Compound Heterozygous Cohort | Number of Participants With ≥ 5% Reduction in Body Weight From Baseline After 3 Months of Setmelanotide Treatment | 14 Participants |
| SH2B1 Cohort | Number of Participants With ≥ 5% Reduction in Body Weight From Baseline After 3 Months of Setmelanotide Treatment | 8 Participants |
| SMS Cohort | Number of Participants With ≥ 5% Reduction in Body Weight From Baseline After 3 Months of Setmelanotide Treatment | 1 Participants |
| SRC1 Cohort | Number of Participants With ≥ 5% Reduction in Body Weight From Baseline After 3 Months of Setmelanotide Treatment | 9 Participants |
Secondary
Change From Baseline in Body Weight After 3 Months of Setmelanotide Treatment
Time frame: Baseline, Month 3
Population: Participants in the FAS were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 16p11.2 Cohort | Change From Baseline in Body Weight After 3 Months of Setmelanotide Treatment | -2.58 kg | Standard Deviation 4.886 |
| AS Cohort | Change From Baseline in Body Weight After 3 Months of Setmelanotide Treatment | -5.16 kg | Standard Deviation 3.86 |
| BBS Cohort | Change From Baseline in Body Weight After 3 Months of Setmelanotide Treatment | -4.61 kg | Standard Deviation 7.771 |
| MC4R Cohort | Change From Baseline in Body Weight After 3 Months of Setmelanotide Treatment | -1.26 kg | Standard Deviation 4.851 |
| POMC/PCSK1/LEPR Heterozygous Cohort | Change From Baseline in Body Weight After 3 Months of Setmelanotide Treatment | -4.74 kg | Standard Deviation 7.689 |
| POMC/PCSK1/LEPR Composite Heterozygous Cohort | Change From Baseline in Body Weight After 3 Months of Setmelanotide Treatment | -0.11 kg | Standard Deviation 2.432 |
| POMC/PCSK1/LEPR Compound Heterozygous Cohort | Change From Baseline in Body Weight After 3 Months of Setmelanotide Treatment | -7.24 kg | Standard Deviation 6.657 |
| SH2B1 Cohort | Change From Baseline in Body Weight After 3 Months of Setmelanotide Treatment | -3.98 kg | Standard Deviation 5.164 |
| SMS Cohort | Change From Baseline in Body Weight After 3 Months of Setmelanotide Treatment | -0.14 kg | Standard Deviation 2.805 |
| SRC1 Cohort | Change From Baseline in Body Weight After 3 Months of Setmelanotide Treatment | -3.96 kg | Standard Deviation 4.37 |
Secondary
Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years
The mean change in daily hunger questionnaire scores for participants \< 12 years of age with obesity in treatment with setmelanotide was evaluated. Hunger was assessed daily using a Daily Hunger Questionnaire with a pictorial (smiley face) version of the Likert rating scale with scores ranged from 0 to 4, with 0 = not hungry at all and 4 = hungriest possible.
Time frame: Baseline, Month 3
Population: Participants \< 12 years of age in the FAS with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 16p11.2 Cohort | Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Baseline: Hunger Right Now | 2.32 units on a scale | Standard Deviation 0.741 |
| 16p11.2 Cohort | Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Change at Month 3: Hunger Right Now | -1.57 units on a scale | Standard Deviation 0.261 |
| MC4R Cohort | Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Change at Month 3: Hunger Right Now | -0.72 units on a scale | Standard Deviation 1.346 |
| MC4R Cohort | Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Baseline: Hunger Right Now | 2.02 units on a scale | Standard Deviation 1.3 |
| POMC/PCSK1/LEPR Compound Heterozygous Cohort | Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Baseline: Hunger Right Now | 2.17 units on a scale | Standard Deviation 1.443 |
| POMC/PCSK1/LEPR Compound Heterozygous Cohort | Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Change at Month 3: Hunger Right Now | -1.55 units on a scale | Standard Deviation 0.91 |
| SH2B1 Cohort | Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Baseline: Hunger Right Now | 1.87 units on a scale | Standard Deviation 0.125 |
| SH2B1 Cohort | Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Change at Month 3: Hunger Right Now | -1.44 units on a scale | Standard Deviation 0.387 |
Secondary
Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years
The mean change in daily hunger questionnaire scores for participants ≥ 12 years of age with obesity in treatment with setmelanotide was evaluated. On the Daily Hunger Questionnaire, each of the 3 items (average hunger in the last 24 hours, most/worst hunger in the last 24 hours, and morning hunger) was assessed daily and scored separately using a numeric rating score for each from 0 to 10, with 0 = not hungry at all and 10 = hungriest possible.
Time frame: Baseline, Month 3
Population: Participants aged ≥ 12 years in the FAS with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 16p11.2 Cohort | Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Baseline: Hunger Score at Most Hungry Last 24 hours | 7.23 units on a scale | Standard Deviation 2.168 |
| 16p11.2 Cohort | Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Change at Month 3: Hunger Score in Morning | -2.34 units on a scale | Standard Deviation 3.39 |
| 16p11.2 Cohort | Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Change at Month 3: Hunger Score on Average Last 24 hours | -2.57 units on a scale | Standard Deviation 2.602 |
| 16p11.2 Cohort | Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Baseline: Hunger Score on Average Last 24 hours | 6.11 units on a scale | Standard Deviation 2.102 |
| 16p11.2 Cohort | Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Baseline: Hunger Score in Morning | 5.24 units on a scale | Standard Deviation 2.508 |
| 16p11.2 Cohort | Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Change at Month 3: Hunger Score at Most Hungry Last 24 hours | -2.85 units on a scale | Standard Deviation 2.561 |
| AS Cohort | Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Change at Month 3: Hunger Score in Morning | -3.90 units on a scale | Standard Deviation 4.195 |
| AS Cohort | Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Baseline: Hunger Score in Morning | 4.98 units on a scale | Standard Deviation 3.187 |
| AS Cohort | Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Change at Month 3: Hunger Score on Average Last 24 hours | -1.23 units on a scale | Standard Deviation 2.739 |
| AS Cohort | Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Change at Month 3: Hunger Score at Most Hungry Last 24 hours | -2.27 units on a scale | Standard Deviation 3.656 |
| AS Cohort | Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Baseline: Hunger Score at Most Hungry Last 24 hours | 6.06 units on a scale | Standard Deviation 2.185 |
| AS Cohort | Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Baseline: Hunger Score on Average Last 24 hours | 5.07 units on a scale | Standard Deviation 1.86 |
| BBS Cohort | Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Baseline: Hunger Score at Most Hungry Last 24 hours | 7.50 units on a scale | Standard Deviation 1.407 |
| BBS Cohort | Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Baseline: Hunger Score in Morning | 5.31 units on a scale | Standard Deviation 2.705 |
| BBS Cohort | Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Change at Month 3: Hunger Score in Morning | -3.14 units on a scale | Standard Deviation 3.173 |
| BBS Cohort | Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Change at Month 3: Hunger Score at Most Hungry Last 24 hours | -4.00 units on a scale | Standard Deviation 2.717 |
| BBS Cohort | Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Baseline: Hunger Score on Average Last 24 hours | 6.37 units on a scale | Standard Deviation 1.719 |
| BBS Cohort | Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Change at Month 3: Hunger Score on Average Last 24 hours | -3.21 units on a scale | Standard Deviation 2.858 |
| MC4R Cohort | Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Change at Month 3: Hunger Score on Average Last 24 hours | -2.50 units on a scale | Standard Deviation 2.278 |
| MC4R Cohort | Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Baseline: Hunger Score on Average Last 24 hours | 5.74 units on a scale | Standard Deviation 1.915 |
| MC4R Cohort | Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Baseline: Hunger Score at Most Hungry Last 24 hours | 6.84 units on a scale | Standard Deviation 1.866 |
| MC4R Cohort | Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Change at Month 3: Hunger Score at Most Hungry Last 24 hours | -2.91 units on a scale | Standard Deviation 2.155 |
| MC4R Cohort | Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Baseline: Hunger Score in Morning | 3.99 units on a scale | Standard Deviation 2.805 |
| MC4R Cohort | Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Change at Month 3: Hunger Score in Morning | -2.14 units on a scale | Standard Deviation 2.914 |
| POMC/PCSK1/LEPR Heterozygous Cohort | Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Baseline: Hunger Score on Average Last 24 hours | 5.73 units on a scale | Standard Deviation 2.178 |
| POMC/PCSK1/LEPR Heterozygous Cohort | Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Baseline: Hunger Score in Morning | 3.89 units on a scale | Standard Deviation 2.589 |
| POMC/PCSK1/LEPR Heterozygous Cohort | Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Baseline: Hunger Score at Most Hungry Last 24 hours | 6.95 units on a scale | Standard Deviation 2.281 |
| POMC/PCSK1/LEPR Heterozygous Cohort | Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Change at Month 3: Hunger Score at Most Hungry Last 24 hours | -3.00 units on a scale | Standard Deviation 2.264 |
| POMC/PCSK1/LEPR Heterozygous Cohort | Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Change at Month 3: Hunger Score in Morning | -2.85 units on a scale | Standard Deviation 2.084 |
| POMC/PCSK1/LEPR Heterozygous Cohort | Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Change at Month 3: Hunger Score on Average Last 24 hours | -2.71 units on a scale | Standard Deviation 1.946 |
| POMC/PCSK1/LEPR Composite Heterozygous Cohort | Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Change at Month 3: Hunger Score at Most Hungry Last 24 hours | -4.07 units on a scale | Standard Deviation 2.929 |
| POMC/PCSK1/LEPR Composite Heterozygous Cohort | Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Baseline: Hunger Score on Average Last 24 hours | 8.07 units on a scale | Standard Deviation 1.348 |
| POMC/PCSK1/LEPR Composite Heterozygous Cohort | Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Baseline: Hunger Score in Morning | 7.04 units on a scale | Standard Deviation 2.437 |
| POMC/PCSK1/LEPR Composite Heterozygous Cohort | Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Change at Month 3: Hunger Score in Morning | -2.36 units on a scale | Standard Deviation 1.111 |
| POMC/PCSK1/LEPR Composite Heterozygous Cohort | Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Baseline: Hunger Score at Most Hungry Last 24 hours | 8.82 units on a scale | Standard Deviation 0.936 |
| POMC/PCSK1/LEPR Composite Heterozygous Cohort | Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Change at Month 3: Hunger Score on Average Last 24 hours | -3.21 units on a scale | Standard Deviation 2.525 |
| POMC/PCSK1/LEPR Compound Heterozygous Cohort | Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Baseline: Hunger Score at Most Hungry Last 24 hours | 7.45 units on a scale | Standard Deviation 2.376 |
| POMC/PCSK1/LEPR Compound Heterozygous Cohort | Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Change at Month 3: Hunger Score on Average Last 24 hours | -3.12 units on a scale | Standard Deviation 1.911 |
| POMC/PCSK1/LEPR Compound Heterozygous Cohort | Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Change at Month 3: Hunger Score in Morning | -3.15 units on a scale | Standard Deviation 1.781 |
| POMC/PCSK1/LEPR Compound Heterozygous Cohort | Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Change at Month 3: Hunger Score at Most Hungry Last 24 hours | -3.70 units on a scale | Standard Deviation 2.501 |
| POMC/PCSK1/LEPR Compound Heterozygous Cohort | Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Baseline: Hunger Score in Morning | 5.14 units on a scale | Standard Deviation 2.537 |
| POMC/PCSK1/LEPR Compound Heterozygous Cohort | Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Baseline: Hunger Score on Average Last 24 hours | 6.32 units on a scale | Standard Deviation 2.062 |
| SH2B1 Cohort | Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Baseline: Hunger Score in Morning | 4.96 units on a scale | Standard Deviation 2.829 |
| SH2B1 Cohort | Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Change at Month 3: Hunger Score at Most Hungry Last 24 hours | -2.68 units on a scale | Standard Deviation 2.915 |
| SH2B1 Cohort | Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Baseline: Hunger Score at Most Hungry Last 24 hours | 7.42 units on a scale | Standard Deviation 1.87 |
| SH2B1 Cohort | Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Change at Month 3: Hunger Score on Average Last 24 hours | -2.78 units on a scale | Standard Deviation 2.639 |
| SH2B1 Cohort | Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Change at Month 3: Hunger Score in Morning | -3.09 units on a scale | Standard Deviation 1.961 |
| SH2B1 Cohort | Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Baseline: Hunger Score on Average Last 24 hours | 6.66 units on a scale | Standard Deviation 1.966 |
| SRC1 Cohort | Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Change at Month 3: Hunger Score in Morning | -1.88 units on a scale | Standard Deviation 1.942 |
| SRC1 Cohort | Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Baseline: Hunger Score in Morning | 4.60 units on a scale | Standard Deviation 2.924 |
| SRC1 Cohort | Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Baseline: Hunger Score on Average Last 24 hours | 6.04 units on a scale | Standard Deviation 2.049 |
| SRC1 Cohort | Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Change at Month 3: Hunger Score at Most Hungry Last 24 hours | -2.67 units on a scale | Standard Deviation 2.241 |
| SRC1 Cohort | Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Baseline: Hunger Score at Most Hungry Last 24 hours | 6.91 units on a scale | Standard Deviation 1.952 |
| SRC1 Cohort | Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Change at Month 3: Hunger Score on Average Last 24 hours | -2.47 units on a scale | Standard Deviation 2.003 |
Secondary
Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years
For participants \< 12 years of age, the following question was asked to parents or caregivers of participants using the Global Hunger Questionnaire: How hungry is your child acting now? Possible responses were: Not hungry at all; A little hungry; Moderately hungry; Extremely hungry; and Not answered.
Time frame: Baseline, Month 3
Population: Participants \< 12 years of age in the FAS with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 16p11.2 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Not hungry at all (Baseline) - Extremely hungry (Month 3) | 0 participants |
| 16p11.2 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Moderately hungry (Baseline) - Extremely hungry (Month 3) | 0 participants |
| 16p11.2 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Extremely hungry (Baseline) - A little hungry (Month 3) | 1 participants |
| 16p11.2 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Not hungry at all (Baseline) - Not hungry at all (Month 3) | 0 participants |
| 16p11.2 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Moderately hungry (Baseline) - Not answered (Month 3) | 0 participants |
| 16p11.2 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Extremely hungry (Baseline) - Not hungry at all (Month 3) | 0 participants |
| 16p11.2 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Not answered (Baseline) - Extremely hungry (Month 3) | 0 participants |
| 16p11.2 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Not hungry at all (Baseline) - Not answered (Month 3) | 0 participants |
| 16p11.2 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Not answered (Baseline) - Moderately hungry (Month 3) | 0 participants |
| 16p11.2 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | A little hungry (Baseline) - Not hungry at all (Month 3) | 0 participants |
| 16p11.2 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Not hungry at all (Baseline) - A little hungry (Month 3) | 0 participants |
| 16p11.2 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Not answered (Baseline) - A little hungry (Month 3) | 0 participants |
| 16p11.2 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | A little hungry (Baseline) - A little hungry (Month 3) | 1 participants |
| 16p11.2 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | A little hungry (Baseline) - Moderately hungry (Month 3) | 0 participants |
| 16p11.2 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Not answered (Baseline) - Not hungry at all (Month 3) | 0 participants |
| 16p11.2 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | A little hungry (Baseline) - Extremely hungry (Month 3) | 0 participants |
| 16p11.2 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Extremely hungry (Baseline) - Not answered (Month 3) | 0 participants |
| 16p11.2 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | A little hungry (Baseline) - Not answered (Month 3) | 0 participants |
| 16p11.2 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Not answered (Baseline) - Not answered (Month 3) | 0 participants |
| 16p11.2 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Moderately hungry (Baseline) - Not hungry at all (Month 3) | 0 participants |
| 16p11.2 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Extremely hungry (Baseline) - Extremely hungry (Month 3) | 0 participants |
| 16p11.2 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Moderately hungry (Baseline) - A little hungry (Month 3) | 0 participants |
| 16p11.2 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Not hungry at all (Baseline) - Moderately hungry (Month 3) | 0 participants |
| 16p11.2 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Extremely hungry (Baseline) - Moderately hungry (Month 3) | 0 participants |
| 16p11.2 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Moderately hungry (Baseline) - Moderately hungry (Month 3) | 0 participants |
| MC4R Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | A little hungry (Baseline) - A little hungry (Month 3) | 1 participants |
| MC4R Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Not answered (Baseline) - Not answered (Month 3) | 0 participants |
| MC4R Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Extremely hungry (Baseline) - Extremely hungry (Month 3) | 1 participants |
| MC4R Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | A little hungry (Baseline) - Not hungry at all (Month 3) | 0 participants |
| MC4R Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Not answered (Baseline) - A little hungry (Month 3) | 0 participants |
| MC4R Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Moderately hungry (Baseline) - Not hungry at all (Month 3) | 0 participants |
| MC4R Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Not hungry at all (Baseline) - Not answered (Month 3) | 0 participants |
| MC4R Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Not hungry at all (Baseline) - A little hungry (Month 3) | 0 participants |
| MC4R Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Not answered (Baseline) - Not hungry at all (Month 3) | 0 participants |
| MC4R Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | A little hungry (Baseline) - Moderately hungry (Month 3) | 1 participants |
| MC4R Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Extremely hungry (Baseline) - Moderately hungry (Month 3) | 0 participants |
| MC4R Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | A little hungry (Baseline) - Extremely hungry (Month 3) | 0 participants |
| MC4R Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Extremely hungry (Baseline) - A little hungry (Month 3) | 2 participants |
| MC4R Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Moderately hungry (Baseline) - Extremely hungry (Month 3) | 0 participants |
| MC4R Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Extremely hungry (Baseline) - Not answered (Month 3) | 0 participants |
| MC4R Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Moderately hungry (Baseline) - Moderately hungry (Month 3) | 0 participants |
| MC4R Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Moderately hungry (Baseline) - A little hungry (Month 3) | 0 participants |
| MC4R Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Moderately hungry (Baseline) - Not answered (Month 3) | 0 participants |
| MC4R Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Not hungry at all (Baseline) - Not hungry at all (Month 3) | 1 participants |
| MC4R Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Extremely hungry (Baseline) - Not hungry at all (Month 3) | 0 participants |
| MC4R Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | A little hungry (Baseline) - Not answered (Month 3) | 0 participants |
| MC4R Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Not answered (Baseline) - Extremely hungry (Month 3) | 0 participants |
| MC4R Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Not hungry at all (Baseline) - Moderately hungry (Month 3) | 0 participants |
| MC4R Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Not hungry at all (Baseline) - Extremely hungry (Month 3) | 1 participants |
| MC4R Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Not answered (Baseline) - Moderately hungry (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Composite Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | A little hungry (Baseline) - Extremely hungry (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Composite Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Not hungry at all (Baseline) - Not answered (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Composite Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Extremely hungry (Baseline) - A little hungry (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Composite Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Extremely hungry (Baseline) - Extremely hungry (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Composite Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Not answered (Baseline) - A little hungry (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Composite Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Not answered (Baseline) - Moderately hungry (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Composite Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Not hungry at all (Baseline) - Not hungry at all (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Composite Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | A little hungry (Baseline) - Not hungry at all (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Composite Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Moderately hungry (Baseline) - Moderately hungry (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Composite Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Extremely hungry (Baseline) - Not hungry at all (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Composite Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Moderately hungry (Baseline) - Extremely hungry (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Composite Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Moderately hungry (Baseline) - Not hungry at all (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Composite Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Not hungry at all (Baseline) - Moderately hungry (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Composite Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | A little hungry (Baseline) - A little hungry (Month 3) | 1 participants |
| POMC/PCSK1/LEPR Composite Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Moderately hungry (Baseline) - A little hungry (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Composite Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Not answered (Baseline) - Not hungry at all (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Composite Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Not hungry at all (Baseline) - Extremely hungry (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Composite Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Not answered (Baseline) - Extremely hungry (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Composite Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Not answered (Baseline) - Not answered (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Composite Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | A little hungry (Baseline) - Moderately hungry (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Composite Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Not hungry at all (Baseline) - A little hungry (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Composite Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | A little hungry (Baseline) - Not answered (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Composite Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Extremely hungry (Baseline) - Not answered (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Composite Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Extremely hungry (Baseline) - Moderately hungry (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Composite Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Moderately hungry (Baseline) - Not answered (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Compound Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Extremely hungry (Baseline) - Not hungry at all (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Compound Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Not hungry at all (Baseline) - Not hungry at all (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Compound Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Not hungry at all (Baseline) - A little hungry (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Compound Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Not hungry at all (Baseline) - Moderately hungry (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Compound Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Not hungry at all (Baseline) - Extremely hungry (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Compound Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Not hungry at all (Baseline) - Not answered (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Compound Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | A little hungry (Baseline) - Not hungry at all (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Compound Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | A little hungry (Baseline) - A little hungry (Month 3) | 2 participants |
| POMC/PCSK1/LEPR Compound Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | A little hungry (Baseline) - Moderately hungry (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Compound Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | A little hungry (Baseline) - Extremely hungry (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Compound Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | A little hungry (Baseline) - Not answered (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Compound Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Moderately hungry (Baseline) - Not hungry at all (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Compound Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Moderately hungry (Baseline) - A little hungry (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Compound Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Moderately hungry (Baseline) - Moderately hungry (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Compound Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Moderately hungry (Baseline) - Extremely hungry (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Compound Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Moderately hungry (Baseline) - Not answered (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Compound Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Extremely hungry (Baseline) - A little hungry (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Compound Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Extremely hungry (Baseline) - Moderately hungry (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Compound Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Extremely hungry (Baseline) - Extremely hungry (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Compound Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Extremely hungry (Baseline) - Not answered (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Compound Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Not answered (Baseline) - Not hungry at all (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Compound Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Not answered (Baseline) - A little hungry (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Compound Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Not answered (Baseline) - Moderately hungry (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Compound Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Not answered (Baseline) - Extremely hungry (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Compound Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Not answered (Baseline) - Not answered (Month 3) | 0 participants |
| SH2B1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Moderately hungry (Baseline) - A little hungry (Month 3) | 0 participants |
| SH2B1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Moderately hungry (Baseline) - Not hungry at all (Month 3) | 0 participants |
| SH2B1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | A little hungry (Baseline) - Not hungry at all (Month 3) | 0 participants |
| SH2B1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | A little hungry (Baseline) - Extremely hungry (Month 3) | 0 participants |
| SH2B1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Not hungry at all (Baseline) - Not hungry at all (Month 3) | 0 participants |
| SH2B1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Not answered (Baseline) - A little hungry (Month 3) | 0 participants |
| SH2B1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Not answered (Baseline) - Extremely hungry (Month 3) | 0 participants |
| SH2B1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Not hungry at all (Baseline) - Not answered (Month 3) | 0 participants |
| SH2B1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Not hungry at all (Baseline) - A little hungry (Month 3) | 0 participants |
| SH2B1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Not hungry at all (Baseline) - Extremely hungry (Month 3) | 0 participants |
| SH2B1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Extremely hungry (Baseline) - Not answered (Month 3) | 0 participants |
| SH2B1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Not answered (Baseline) - Moderately hungry (Month 3) | 0 participants |
| SH2B1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | A little hungry (Baseline) - Not answered (Month 3) | 0 participants |
| SH2B1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | A little hungry (Baseline) - Moderately hungry (Month 3) | 0 participants |
| SH2B1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Not hungry at all (Baseline) - Moderately hungry (Month 3) | 0 participants |
| SH2B1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Extremely hungry (Baseline) - Moderately hungry (Month 3) | 0 participants |
| SH2B1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | A little hungry (Baseline) - A little hungry (Month 3) | 1 participants |
| SH2B1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Moderately hungry (Baseline) - Not answered (Month 3) | 0 participants |
| SH2B1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Extremely hungry (Baseline) - A little hungry (Month 3) | 0 participants |
| SH2B1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Extremely hungry (Baseline) - Not hungry at all (Month 3) | 0 participants |
| SH2B1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Extremely hungry (Baseline) - Extremely hungry (Month 3) | 0 participants |
| SH2B1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Moderately hungry (Baseline) - Extremely hungry (Month 3) | 0 participants |
| SH2B1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Not answered (Baseline) - Not hungry at all (Month 3) | 0 participants |
| SH2B1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Moderately hungry (Baseline) - Moderately hungry (Month 3) | 1 participants |
| SH2B1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Not answered (Baseline) - Not answered (Month 3) | 0 participants |
| SRC1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Moderately hungry (Baseline) - Extremely hungry (Month 3) | 0 participants |
| SRC1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Extremely hungry (Baseline) - A little hungry (Month 3) | 1 participants |
| SRC1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Moderately hungry (Baseline) - A little hungry (Month 3) | 0 participants |
| SRC1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Moderately hungry (Baseline) - Not hungry at all (Month 3) | 0 participants |
| SRC1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Extremely hungry (Baseline) - Moderately hungry (Month 3) | 0 participants |
| SRC1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | A little hungry (Baseline) - Not answered (Month 3) | 0 participants |
| SRC1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Not answered (Baseline) - Extremely hungry (Month 3) | 0 participants |
| SRC1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Extremely hungry (Baseline) - Extremely hungry (Month 3) | 0 participants |
| SRC1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | A little hungry (Baseline) - Extremely hungry (Month 3) | 0 participants |
| SRC1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | A little hungry (Baseline) - Moderately hungry (Month 3) | 0 participants |
| SRC1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Extremely hungry (Baseline) - Not answered (Month 3) | 0 participants |
| SRC1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | A little hungry (Baseline) - A little hungry (Month 3) | 0 participants |
| SRC1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Not hungry at all (Baseline) - Not hungry at all (Month 3) | 0 participants |
| SRC1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Not answered (Baseline) - Not hungry at all (Month 3) | 0 participants |
| SRC1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | A little hungry (Baseline) - Not hungry at all (Month 3) | 0 participants |
| SRC1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Not hungry at all (Baseline) - Not answered (Month 3) | 0 participants |
| SRC1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Not answered (Baseline) - A little hungry (Month 3) | 0 participants |
| SRC1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Not hungry at all (Baseline) - Extremely hungry (Month 3) | 0 participants |
| SRC1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Not answered (Baseline) - Not answered (Month 3) | 0 participants |
| SRC1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Not answered (Baseline) - Moderately hungry (Month 3) | 0 participants |
| SRC1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Not hungry at all (Baseline) - Moderately hungry (Month 3) | 0 participants |
| SRC1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Not hungry at all (Baseline) - A little hungry (Month 3) | 0 participants |
| SRC1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Moderately hungry (Baseline) - Not answered (Month 3) | 0 participants |
| SRC1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Extremely hungry (Baseline) - Not hungry at all (Month 3) | 1 participants |
| SRC1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Moderately hungry (Baseline) - Moderately hungry (Month 3) | 0 participants |
Secondary
Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years
For participants ≥ 12 years of age, the following question was asked using the Global Hunger Questionnaire: Overall, how would you rate the hunger you experience now? Possible responses were: No hunger; Mild hunger; Moderate hunger; Severe hunger; and Not answered.
Time frame: Baseline, Month 3
Population: Participants ≥ 12 years of age in the FAS with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 16p11.2 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Severe hunger (Baseline) - Not answered (Month 3) | 0 participants |
| 16p11.2 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Mild hunger (Baseline) - No hunger (Month 3) | 0 participants |
| 16p11.2 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Moderate hunger (Baseline) - No hunger (Month 3) | 2 participants |
| 16p11.2 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Severe hunger (Baseline) - Severe hunger (Month 3) | 0 participants |
| 16p11.2 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Mild hunger (Baseline) - Moderate hunger (Month 3) | 1 participants |
| 16p11.2 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Mild hunger (Baseline) - Mild hunger (Month 3) | 1 participants |
| 16p11.2 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Moderate hunger (Baseline) - Severe hunger (Month 3) | 0 participants |
| 16p11.2 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Severe hunger (Baseline) - Moderate hunger (Month 3) | 1 participants |
| 16p11.2 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Not answered (Baseline) - Severe hunger (Month 3) | 0 participants |
| 16p11.2 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Mild hunger (Baseline) - Not answered (Month 3) | 0 participants |
| 16p11.2 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | No hunger (Baseline) - Mild hunger (Month 3) | 0 participants |
| 16p11.2 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | No hunger (Baseline) - Moderate hunger (Month 3) | 0 participants |
| 16p11.2 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Moderate hunger (Baseline) - Not answered (Month 3) | 0 participants |
| 16p11.2 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Moderate hunger (Baseline) - Moderate hunger (Month 3) | 2 participants |
| 16p11.2 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Not answered (Baseline) - Moderate hunger (Month 3) | 0 participants |
| 16p11.2 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | No hunger (Baseline) - Severe hunger (Month 3) | 0 participants |
| 16p11.2 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Not answered (Baseline) - Not answered (Month 3) | 0 participants |
| 16p11.2 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Not answered (Baseline) - Mild hunger (Month 3) | 0 participants |
| 16p11.2 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Mild hunger (Baseline) - Severe hunger (Month 3) | 0 participants |
| 16p11.2 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Not answered (Baseline) - No hunger (Month 3) | 0 participants |
| 16p11.2 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | No hunger (Baseline) - Not answered (Month 3) | 0 participants |
| 16p11.2 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Moderate hunger (Baseline) - Mild hunger (Month 3) | 4 participants |
| 16p11.2 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Severe hunger (Baseline) - No hunger (Month 3) | 1 participants |
| 16p11.2 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | No hunger (Baseline) - No hunger (Month 3) | 2 participants |
| 16p11.2 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Severe hunger (Baseline) - Mild hunger (Month 3) | 1 participants |
| AS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Moderate hunger (Baseline) - Mild hunger (Month 3) | 0 participants |
| AS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Not answered (Baseline) - Moderate hunger (Month 3) | 0 participants |
| AS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Mild hunger (Baseline) - No hunger (Month 3) | 0 participants |
| AS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Not answered (Baseline) - No hunger (Month 3) | 0 participants |
| AS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Not answered (Baseline) - Not answered (Month 3) | 0 participants |
| AS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Mild hunger (Baseline) - Moderate hunger (Month 3) | 0 participants |
| AS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Mild hunger (Baseline) - Not answered (Month 3) | 0 participants |
| AS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Severe hunger (Baseline) - Severe hunger (Month 3) | 0 participants |
| AS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Moderate hunger (Baseline) - Not answered (Month 3) | 0 participants |
| AS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Moderate hunger (Baseline) - Severe hunger (Month 3) | 0 participants |
| AS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | No hunger (Baseline) - No hunger (Month 3) | 0 participants |
| AS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Not answered (Baseline) - Mild hunger (Month 3) | 0 participants |
| AS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Mild hunger (Baseline) - Mild hunger (Month 3) | 2 participants |
| AS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | No hunger (Baseline) - Mild hunger (Month 3) | 0 participants |
| AS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Severe hunger (Baseline) - Mild hunger (Month 3) | 1 participants |
| AS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Not answered (Baseline) - Severe hunger (Month 3) | 0 participants |
| AS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Severe hunger (Baseline) - Moderate hunger (Month 3) | 0 participants |
| AS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | No hunger (Baseline) - Severe hunger (Month 3) | 0 participants |
| AS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Moderate hunger (Baseline) - No hunger (Month 3) | 0 participants |
| AS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Severe hunger (Baseline) - Not answered (Month 3) | 0 participants |
| AS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Mild hunger (Baseline) - Severe hunger (Month 3) | 0 participants |
| AS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | No hunger (Baseline) - Not answered (Month 3) | 0 participants |
| AS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | No hunger (Baseline) - Moderate hunger (Month 3) | 0 participants |
| AS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Moderate hunger (Baseline) - Moderate hunger (Month 3) | 0 participants |
| AS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Severe hunger (Baseline) - No hunger (Month 3) | 0 participants |
| BBS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Moderate hunger (Baseline) - Not answered (Month 3) | 0 participants |
| BBS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Moderate hunger (Baseline) - No hunger (Month 3) | 0 participants |
| BBS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Moderate hunger (Baseline) - Mild hunger (Month 3) | 4 participants |
| BBS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | No hunger (Baseline) - Mild hunger (Month 3) | 1 participants |
| BBS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Not answered (Baseline) - Severe hunger (Month 3) | 0 participants |
| BBS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Not answered (Baseline) - Moderate hunger (Month 3) | 0 participants |
| BBS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | No hunger (Baseline) - Moderate hunger (Month 3) | 0 participants |
| BBS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | No hunger (Baseline) - No hunger (Month 3) | 0 participants |
| BBS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Not answered (Baseline) - Mild hunger (Month 3) | 0 participants |
| BBS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | No hunger (Baseline) - Severe hunger (Month 3) | 0 participants |
| BBS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Not answered (Baseline) - No hunger (Month 3) | 0 participants |
| BBS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | No hunger (Baseline) - Not answered (Month 3) | 0 participants |
| BBS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Severe hunger (Baseline) - Not answered (Month 3) | 0 participants |
| BBS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Mild hunger (Baseline) - No hunger (Month 3) | 0 participants |
| BBS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Severe hunger (Baseline) - Severe hunger (Month 3) | 0 participants |
| BBS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Severe hunger (Baseline) - Moderate hunger (Month 3) | 0 participants |
| BBS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Mild hunger (Baseline) - Mild hunger (Month 3) | 2 participants |
| BBS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Not answered (Baseline) - Not answered (Month 3) | 0 participants |
| BBS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Severe hunger (Baseline) - Mild hunger (Month 3) | 0 participants |
| BBS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Mild hunger (Baseline) - Moderate hunger (Month 3) | 0 participants |
| BBS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Severe hunger (Baseline) - No hunger (Month 3) | 1 participants |
| BBS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Mild hunger (Baseline) - Severe hunger (Month 3) | 0 participants |
| BBS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Moderate hunger (Baseline) - Moderate hunger (Month 3) | 0 participants |
| BBS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Mild hunger (Baseline) - Not answered (Month 3) | 0 participants |
| BBS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Moderate hunger (Baseline) - Severe hunger (Month 3) | 0 participants |
| MC4R Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Mild hunger (Baseline) - No hunger (Month 3) | 2 participants |
| MC4R Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Severe hunger (Baseline) - Severe hunger (Month 3) | 0 participants |
| MC4R Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Severe hunger (Baseline) - No hunger (Month 3) | 1 participants |
| MC4R Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Not answered (Baseline) - Severe hunger (Month 3) | 0 participants |
| MC4R Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Severe hunger (Baseline) - Not answered (Month 3) | 0 participants |
| MC4R Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | No hunger (Baseline) - Not answered (Month 3) | 0 participants |
| MC4R Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Not answered (Baseline) - No hunger (Month 3) | 0 participants |
| MC4R Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | No hunger (Baseline) - No hunger (Month 3) | 1 participants |
| MC4R Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Moderate hunger (Baseline) - Moderate hunger (Month 3) | 2 participants |
| MC4R Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Mild hunger (Baseline) - Severe hunger (Month 3) | 0 participants |
| MC4R Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | No hunger (Baseline) - Severe hunger (Month 3) | 0 participants |
| MC4R Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Moderate hunger (Baseline) - Not answered (Month 3) | 0 participants |
| MC4R Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Moderate hunger (Baseline) - Mild hunger (Month 3) | 4 participants |
| MC4R Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Not answered (Baseline) - Mild hunger (Month 3) | 0 participants |
| MC4R Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | No hunger (Baseline) - Moderate hunger (Month 3) | 1 participants |
| MC4R Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Moderate hunger (Baseline) - Severe hunger (Month 3) | 0 participants |
| MC4R Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Not answered (Baseline) - Moderate hunger (Month 3) | 0 participants |
| MC4R Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | No hunger (Baseline) - Mild hunger (Month 3) | 2 participants |
| MC4R Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Severe hunger (Baseline) - Mild hunger (Month 3) | 5 participants |
| MC4R Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Moderate hunger (Baseline) - No hunger (Month 3) | 1 participants |
| MC4R Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Mild hunger (Baseline) - Mild hunger (Month 3) | 5 participants |
| MC4R Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Severe hunger (Baseline) - Moderate hunger (Month 3) | 1 participants |
| MC4R Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Not answered (Baseline) - Not answered (Month 3) | 0 participants |
| MC4R Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Mild hunger (Baseline) - Not answered (Month 3) | 0 participants |
| MC4R Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Mild hunger (Baseline) - Moderate hunger (Month 3) | 2 participants |
| POMC/PCSK1/LEPR Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Moderate hunger (Baseline) - Moderate hunger (Month 3) | 1 participants |
| POMC/PCSK1/LEPR Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | No hunger (Baseline) - No hunger (Month 3) | 2 participants |
| POMC/PCSK1/LEPR Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | No hunger (Baseline) - Mild hunger (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | No hunger (Baseline) - Moderate hunger (Month 3) | 1 participants |
| POMC/PCSK1/LEPR Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | No hunger (Baseline) - Severe hunger (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | No hunger (Baseline) - Not answered (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Mild hunger (Baseline) - No hunger (Month 3) | 3 participants |
| POMC/PCSK1/LEPR Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Mild hunger (Baseline) - Mild hunger (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Mild hunger (Baseline) - Moderate hunger (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Mild hunger (Baseline) - Severe hunger (Month 3) | 1 participants |
| POMC/PCSK1/LEPR Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Mild hunger (Baseline) - Not answered (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Moderate hunger (Baseline) - No hunger (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Moderate hunger (Baseline) - Mild hunger (Month 3) | 5 participants |
| POMC/PCSK1/LEPR Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Moderate hunger (Baseline) - Severe hunger (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Moderate hunger (Baseline) - Not answered (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Severe hunger (Baseline) - No hunger (Month 3) | 1 participants |
| POMC/PCSK1/LEPR Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Severe hunger (Baseline) - Mild hunger (Month 3) | 1 participants |
| POMC/PCSK1/LEPR Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Severe hunger (Baseline) - Moderate hunger (Month 3) | 1 participants |
| POMC/PCSK1/LEPR Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Severe hunger (Baseline) - Severe hunger (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Severe hunger (Baseline) - Not answered (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Not answered (Baseline) - No hunger (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Not answered (Baseline) - Mild hunger (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Not answered (Baseline) - Moderate hunger (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Not answered (Baseline) - Severe hunger (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Not answered (Baseline) - Not answered (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Composite Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Moderate hunger (Baseline) - Severe hunger (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Composite Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | No hunger (Baseline) - Mild hunger (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Composite Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Mild hunger (Baseline) - Mild hunger (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Composite Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | No hunger (Baseline) - Moderate hunger (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Composite Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | No hunger (Baseline) - Severe hunger (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Composite Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Severe hunger (Baseline) - No hunger (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Composite Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Not answered (Baseline) - Moderate hunger (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Composite Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Not answered (Baseline) - Severe hunger (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Composite Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Mild hunger (Baseline) - Not answered (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Composite Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Moderate hunger (Baseline) - Moderate hunger (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Composite Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Mild hunger (Baseline) - Moderate hunger (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Composite Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Not answered (Baseline) - Not answered (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Composite Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | No hunger (Baseline) - No hunger (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Composite Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Severe hunger (Baseline) - Mild hunger (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Composite Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Not answered (Baseline) - No hunger (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Composite Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Not answered (Baseline) - Mild hunger (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Composite Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Severe hunger (Baseline) - Not answered (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Composite Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Mild hunger (Baseline) - No hunger (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Composite Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Mild hunger (Baseline) - Severe hunger (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Composite Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | No hunger (Baseline) - Not answered (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Composite Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Moderate hunger (Baseline) - Not answered (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Composite Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Severe hunger (Baseline) - Severe hunger (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Composite Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Severe hunger (Baseline) - Moderate hunger (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Composite Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Moderate hunger (Baseline) - No hunger (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Composite Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Moderate hunger (Baseline) - Mild hunger (Month 3) | 1 participants |
| POMC/PCSK1/LEPR Compound Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Moderate hunger (Baseline) - Moderate hunger (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Compound Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | No hunger (Baseline) - Severe hunger (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Compound Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Not answered (Baseline) - No hunger (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Compound Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | No hunger (Baseline) - Moderate hunger (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Compound Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Mild hunger (Baseline) - Severe hunger (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Compound Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Not answered (Baseline) - Not answered (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Compound Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Not answered (Baseline) - Mild hunger (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Compound Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Moderate hunger (Baseline) - Mild hunger (Month 3) | 4 participants |
| POMC/PCSK1/LEPR Compound Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Moderate hunger (Baseline) - Not answered (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Compound Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Mild hunger (Baseline) - Moderate hunger (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Compound Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Mild hunger (Baseline) - Not answered (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Compound Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Severe hunger (Baseline) - No hunger (Month 3) | 2 participants |
| POMC/PCSK1/LEPR Compound Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Not answered (Baseline) - Severe hunger (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Compound Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Moderate hunger (Baseline) - No hunger (Month 3) | 1 participants |
| POMC/PCSK1/LEPR Compound Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Severe hunger (Baseline) - Mild hunger (Month 3) | 1 participants |
| POMC/PCSK1/LEPR Compound Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Mild hunger (Baseline) - Mild hunger (Month 3) | 4 participants |
| POMC/PCSK1/LEPR Compound Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | No hunger (Baseline) - No hunger (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Compound Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Severe hunger (Baseline) - Moderate hunger (Month 3) | 1 participants |
| POMC/PCSK1/LEPR Compound Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Moderate hunger (Baseline) - Severe hunger (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Compound Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | No hunger (Baseline) - Mild hunger (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Compound Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Mild hunger (Baseline) - No hunger (Month 3) | 2 participants |
| POMC/PCSK1/LEPR Compound Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Severe hunger (Baseline) - Severe hunger (Month 3) | 2 participants |
| POMC/PCSK1/LEPR Compound Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | No hunger (Baseline) - Not answered (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Compound Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Not answered (Baseline) - Moderate hunger (Month 3) | 0 participants |
| POMC/PCSK1/LEPR Compound Heterozygous Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Severe hunger (Baseline) - Not answered (Month 3) | 0 participants |
| SH2B1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Moderate hunger (Baseline) - Not answered (Month 3) | 0 participants |
| SH2B1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Severe hunger (Baseline) - Not answered (Month 3) | 0 participants |
| SH2B1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Severe hunger (Baseline) - Moderate hunger (Month 3) | 0 participants |
| SH2B1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Not answered (Baseline) - No hunger (Month 3) | 0 participants |
| SH2B1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Moderate hunger (Baseline) - Mild hunger (Month 3) | 3 participants |
| SH2B1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Mild hunger (Baseline) - No hunger (Month 3) | 3 participants |
| SH2B1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | No hunger (Baseline) - Severe hunger (Month 3) | 0 participants |
| SH2B1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Not answered (Baseline) - Mild hunger (Month 3) | 0 participants |
| SH2B1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | No hunger (Baseline) - Mild hunger (Month 3) | 0 participants |
| SH2B1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | No hunger (Baseline) - Moderate hunger (Month 3) | 0 participants |
| SH2B1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Mild hunger (Baseline) - Severe hunger (Month 3) | 0 participants |
| SH2B1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Moderate hunger (Baseline) - Moderate hunger (Month 3) | 0 participants |
| SH2B1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Severe hunger (Baseline) - Severe hunger (Month 3) | 0 participants |
| SH2B1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Moderate hunger (Baseline) - Severe hunger (Month 3) | 0 participants |
| SH2B1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | No hunger (Baseline) - No hunger (Month 3) | 0 participants |
| SH2B1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Mild hunger (Baseline) - Mild hunger (Month 3) | 0 participants |
| SH2B1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Not answered (Baseline) - Moderate hunger (Month 3) | 0 participants |
| SH2B1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Severe hunger (Baseline) - Mild hunger (Month 3) | 2 participants |
| SH2B1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Moderate hunger (Baseline) - No hunger (Month 3) | 1 participants |
| SH2B1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Severe hunger (Baseline) - No hunger (Month 3) | 1 participants |
| SH2B1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Not answered (Baseline) - Not answered (Month 3) | 0 participants |
| SH2B1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Mild hunger (Baseline) - Moderate hunger (Month 3) | 0 participants |
| SH2B1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Mild hunger (Baseline) - Not answered (Month 3) | 0 participants |
| SH2B1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Not answered (Baseline) - Severe hunger (Month 3) | 0 participants |
| SH2B1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | No hunger (Baseline) - Not answered (Month 3) | 0 participants |
| SMS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Mild hunger (Baseline) - Not answered (Month 3) | 0 participants |
| SMS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Not answered (Baseline) - Severe hunger (Month 3) | 0 participants |
| SMS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Moderate hunger (Baseline) - Severe hunger (Month 3) | 0 participants |
| SMS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Mild hunger (Baseline) - Severe hunger (Month 3) | 0 participants |
| SMS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Moderate hunger (Baseline) - Not answered (Month 3) | 0 participants |
| SMS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Mild hunger (Baseline) - Moderate hunger (Month 3) | 1 participants |
| SMS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | No hunger (Baseline) - No hunger (Month 3) | 0 participants |
| SMS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Severe hunger (Baseline) - No hunger (Month 3) | 0 participants |
| SMS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Mild hunger (Baseline) - Mild hunger (Month 3) | 1 participants |
| SMS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Severe hunger (Baseline) - Mild hunger (Month 3) | 0 participants |
| SMS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Mild hunger (Baseline) - No hunger (Month 3) | 1 participants |
| SMS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Severe hunger (Baseline) - Moderate hunger (Month 3) | 2 participants |
| SMS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Severe hunger (Baseline) - Severe hunger (Month 3) | 1 participants |
| SMS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | No hunger (Baseline) - Not answered (Month 3) | 0 participants |
| SMS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Severe hunger (Baseline) - Not answered (Month 3) | 0 participants |
| SMS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | No hunger (Baseline) - Severe hunger (Month 3) | 0 participants |
| SMS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Not answered (Baseline) - No hunger (Month 3) | 0 participants |
| SMS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | No hunger (Baseline) - Moderate hunger (Month 3) | 0 participants |
| SMS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Not answered (Baseline) - Mild hunger (Month 3) | 0 participants |
| SMS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | No hunger (Baseline) - Mild hunger (Month 3) | 0 participants |
| SMS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Not answered (Baseline) - Moderate hunger (Month 3) | 0 participants |
| SMS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Not answered (Baseline) - Not answered (Month 3) | 0 participants |
| SMS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Moderate hunger (Baseline) - No hunger (Month 3) | 1 participants |
| SMS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Moderate hunger (Baseline) - Mild hunger (Month 3) | 1 participants |
| SMS Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Moderate hunger (Baseline) - Moderate hunger (Month 3) | 0 participants |
| SRC1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Severe hunger (Baseline) - Not answered (Month 3) | 0 participants |
| SRC1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Not answered (Baseline) - Not answered (Month 3) | 0 participants |
| SRC1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Severe hunger (Baseline) - Severe hunger (Month 3) | 0 participants |
| SRC1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Moderate hunger (Baseline) - Mild hunger (Month 3) | 3 participants |
| SRC1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Not answered (Baseline) - Moderate hunger (Month 3) | 0 participants |
| SRC1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | No hunger (Baseline) - Not answered (Month 3) | 0 participants |
| SRC1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Severe hunger (Baseline) - Moderate hunger (Month 3) | 0 participants |
| SRC1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Mild hunger (Baseline) - No hunger (Month 3) | 4 participants |
| SRC1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | No hunger (Baseline) - No hunger (Month 3) | 1 participants |
| SRC1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Mild hunger (Baseline) - Severe hunger (Month 3) | 0 participants |
| SRC1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Severe hunger (Baseline) - Mild hunger (Month 3) | 2 participants |
| SRC1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Mild hunger (Baseline) - Mild hunger (Month 3) | 5 participants |
| SRC1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Moderate hunger (Baseline) - No hunger (Month 3) | 0 participants |
| SRC1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Moderate hunger (Baseline) - Moderate hunger (Month 3) | 2 participants |
| SRC1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Severe hunger (Baseline) - No hunger (Month 3) | 0 participants |
| SRC1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Mild hunger (Baseline) - Moderate hunger (Month 3) | 1 participants |
| SRC1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Moderate hunger (Baseline) - Not answered (Month 3) | 0 participants |
| SRC1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Not answered (Baseline) - Severe hunger (Month 3) | 0 participants |
| SRC1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Moderate hunger (Baseline) - Severe hunger (Month 3) | 0 participants |
| SRC1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Not answered (Baseline) - Mild hunger (Month 3) | 0 participants |
| SRC1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | No hunger (Baseline) - Moderate hunger (Month 3) | 1 participants |
| SRC1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Not answered (Baseline) - No hunger (Month 3) | 0 participants |
| SRC1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | No hunger (Baseline) - Mild hunger (Month 3) | 1 participants |
| SRC1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Mild hunger (Baseline) - Not answered (Month 3) | 0 participants |
| SRC1 Cohort | Number of Participants With Shifts From Baseline in Global Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | No hunger (Baseline) - Severe hunger (Month 3) | 0 participants |
Secondary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE (also referred to as an adverse experience) could be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality. TEAEs were defined as AEs reported after dosing on Day 1.
Time frame: From first dose up to Month 16
Population: Safety Analysis Set included all participants who received at least 1 dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| 16p11.2 Cohort | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 19 Participants |
| AS Cohort | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 4 Participants |
| BBS Cohort | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 10 Participants |
| MC4R Cohort | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 49 Participants |
| POMC/PCSK1/LEPR Heterozygous Cohort | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 33 Participants |
| POMC/PCSK1/LEPR Composite Heterozygous Cohort | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 5 Participants |
| POMC/PCSK1/LEPR Compound Heterozygous Cohort | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 27 Participants |
| SH2B1 Cohort | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 21 Participants |
| SMS Cohort | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 12 Participants |
| SRC1 Cohort | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 29 Participants |
Secondary
Percent Change From Baseline in Body Weight After 3 Months of Setmelanotide Treatment
Time frame: Baseline, Month 3
Population: Participants in the FAS were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 16p11.2 Cohort | Percent Change From Baseline in Body Weight After 3 Months of Setmelanotide Treatment | -2.19 percent change | Standard Deviation 3.685 |
| AS Cohort | Percent Change From Baseline in Body Weight After 3 Months of Setmelanotide Treatment | -6.38 percent change | Standard Deviation 5.043 |
| BBS Cohort | Percent Change From Baseline in Body Weight After 3 Months of Setmelanotide Treatment | -4.19 percent change | Standard Deviation 5.579 |
| MC4R Cohort | Percent Change From Baseline in Body Weight After 3 Months of Setmelanotide Treatment | -0.75 percent change | Standard Deviation 4.291 |
| POMC/PCSK1/LEPR Heterozygous Cohort | Percent Change From Baseline in Body Weight After 3 Months of Setmelanotide Treatment | -3.50 percent change | Standard Deviation 5.817 |
| POMC/PCSK1/LEPR Composite Heterozygous Cohort | Percent Change From Baseline in Body Weight After 3 Months of Setmelanotide Treatment | -0.31 percent change | Standard Deviation 1.772 |
| POMC/PCSK1/LEPR Compound Heterozygous Cohort | Percent Change From Baseline in Body Weight After 3 Months of Setmelanotide Treatment | -5.57 percent change | Standard Deviation 5.17 |
| SH2B1 Cohort | Percent Change From Baseline in Body Weight After 3 Months of Setmelanotide Treatment | -2.92 percent change | Standard Deviation 3.834 |
| SMS Cohort | Percent Change From Baseline in Body Weight After 3 Months of Setmelanotide Treatment | -0.00 percent change | Standard Deviation 3.651 |
| SRC1 Cohort | Percent Change From Baseline in Body Weight After 3 Months of Setmelanotide Treatment | -3.34 percent change | Standard Deviation 3.607 |
Secondary
Percent Change From Baseline in Waist Circumference After 3 Months of Setmelanotide Treatment
Waist circumference (cm) was measured according to the National Heart, Lung, and Blood Institute (NHLBI) criteria. All measurements were single measures. Waist circumference was measured when participants were in fasting condition and at approximately the same time at each visit.
Time frame: Baseline, Month 3
Population: Participants in the FAS with available data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 16p11.2 Cohort | Percent Change From Baseline in Waist Circumference After 3 Months of Setmelanotide Treatment | -1.00 percent change | Standard Deviation 6.25 |
| AS Cohort | Percent Change From Baseline in Waist Circumference After 3 Months of Setmelanotide Treatment | -6.60 percent change | Standard Deviation 6.828 |
| BBS Cohort | Percent Change From Baseline in Waist Circumference After 3 Months of Setmelanotide Treatment | -4.92 percent change | Standard Deviation 7.191 |
| MC4R Cohort | Percent Change From Baseline in Waist Circumference After 3 Months of Setmelanotide Treatment | -0.61 percent change | Standard Deviation 11.311 |
| POMC/PCSK1/LEPR Heterozygous Cohort | Percent Change From Baseline in Waist Circumference After 3 Months of Setmelanotide Treatment | -1.09 percent change | Standard Deviation 8.25 |
| POMC/PCSK1/LEPR Composite Heterozygous Cohort | Percent Change From Baseline in Waist Circumference After 3 Months of Setmelanotide Treatment | 5.11 percent change | Standard Deviation 8.412 |
| POMC/PCSK1/LEPR Compound Heterozygous Cohort | Percent Change From Baseline in Waist Circumference After 3 Months of Setmelanotide Treatment | -5.59 percent change | Standard Deviation 6.554 |
| SH2B1 Cohort | Percent Change From Baseline in Waist Circumference After 3 Months of Setmelanotide Treatment | -4.91 percent change | Standard Deviation 8.495 |
| SMS Cohort | Percent Change From Baseline in Waist Circumference After 3 Months of Setmelanotide Treatment | -3.83 percent change | Standard Deviation 8.543 |
| SRC1 Cohort | Percent Change From Baseline in Waist Circumference After 3 Months of Setmelanotide Treatment | -2.88 percent change | Standard Deviation 4.632 |