Trial · NCT03013543
Setmelanotide Phase 2 Treatment Trial in Participants With Rare Genetic Disorders of Obesity
NCT03013543, Phase 2, Completed, Rhythm Pharmaceuticals, Inc.; results first posted 2023-08-18
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Setmelanotide Phase 2 Treatment Trial in Participants With Rare Genetic Disorders of Obesity. Trials, record NCT03013543. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03013543
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Setmelanotide Phase 2 Treatment Trial in Participants With Rare Genetic Disorders of Obesity
- NCT number
- NCT03013543
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 213 participants, actual
- Lead sponsor
- Rhythm Pharmaceuticals, Inc.
- Conditions
- Genetic Obesity, Obesity, Obesity Due to Melanocortin 4 Receptor Deficiency
- Interventions
- Setmelanotide
- First posted
- 2017-01-06
- Last updated
- 2023-08-18
- Other registries' IDs
- eudract:2017-000387-14
- Results first posted
- 2023-08-18
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With ≥ 5% Reduction in Body Weight From Baseline After 3 Months of Setmelanotide Treatment | Baseline to Month 3 | |
| Secondary | 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. |
| Secondary | Change From Baseline in Body Weight After 3 Months of Setmelanotide Treatment | Baseline, Month 3 | |
| Secondary | Percent Change From Baseline in Body Weight After 3 Months of Setmelanotide Treatment | Baseline, Month 3 | |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With ≥ 5% Reduction in Body Weight From Baseline After 3 Months of Setmelanotide Treatment | Baseline to Month 3 | Participants in the FAS were analyzed. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | From first dose up to Month 16 | Safety Analysis Set included all participants who received at least 1 dose of study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Body Weight After 3 Months of Setmelanotide Treatment | Baseline, Month 3 | Participants in the FAS were analyzed. | kg | MEAN |
| SECONDARY | Percent Change From Baseline in Body Weight After 3 Months of Setmelanotide Treatment | Baseline, Month 3 | Participants in the FAS were analyzed. | percent change | MEAN |
| SECONDARY | Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged ≥ 12 Years | Baseline, Month 3 | Participants aged ≥ 12 years in the FAS with available data were analyzed. | units on a scale | MEAN |
| SECONDARY | Change From Baseline in Daily Hunger Questionnaire Scores After 3 Months of Setmelanotide Treatment in Participants Aged < 12 Years | Baseline, Month 3 | Participants \< 12 years of age in the FAS with available data were analyzed. | units on a scale | MEAN |
| SECONDARY | 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 | Participants ≥ 12 years of age in the FAS with available data were analyzed. | participants | NUMBER |
| SECONDARY | 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 | Participants \< 12 years of age in the FAS with available data were analyzed. | participants | NUMBER |
| SECONDARY | Percent Change From Baseline in Waist Circumference After 3 Months of Setmelanotide Treatment | Baseline, Month 3 | Participants in the FAS with available data were analyzed. | percent change | MEAN |
Source ClinicalTrials.gov
Results by group512
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With ≥ 5% Reduction in Body Weight From Baseline After 3 Months of Setmelanotide Treatment | 16p11.2 Cohort | 6 | Participants | ||
| Number of Participants With ≥ 5% Reduction in Body Weight From Baseline After 3 Months of Setmelanotide Treatment | AS Cohort | 3 | Participants | ||
| Number of Participants With ≥ 5% Reduction in Body Weight From Baseline After 3 Months of Setmelanotide Treatment | BBS Cohort | 7 | Participants | ||
| Number of Participants With ≥ 5% Reduction in Body Weight From Baseline After 3 Months of Setmelanotide Treatment | MC4R Cohort | 7 | Participants | ||
| Number of Participants With ≥ 5% Reduction in Body Weight From Baseline After 3 Months of Setmelanotide Treatment | POMC/PCSK1/LEPR Heterozygous Cohort | 10 | Participants | ||
| Number of Participants With ≥ 5% Reduction in Body Weight From Baseline After 3 Months of Setmelanotide Treatment | POMC/PCSK1/LEPR Composite Heterozygous Cohort | 0 | Participants | ||
| Number of Participants With ≥ 5% Reduction in Body Weight From Baseline After 3 Months of Setmelanotide Treatment | POMC/PCSK1/LEPR Compound Heterozygous Cohort | 14 | Participants | ||
| Number of Participants With ≥ 5% Reduction in Body Weight From Baseline After 3 Months of Setmelanotide Treatment | SH2B1 Cohort | 8 | Participants | ||
| Number of Participants With ≥ 5% Reduction in Body Weight From Baseline After 3 Months of Setmelanotide Treatment | SMS Cohort | 1 | Participants | ||
| Number of Participants With ≥ 5% Reduction in Body Weight From Baseline After 3 Months of Setmelanotide Treatment | SRC1 Cohort | 9 | Participants |
1 to 10 of 512Source ClinicalTrials.gov
See all 512 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 16p11.2 Cohort | 19 | |
| Overall Study | STARTED | AS Cohort | 4 | |
| Overall Study | STARTED | BBS Cohort | 10 | |
| Overall Study | STARTED | MC4R Cohort | 49 | |
| Overall Study | STARTED | POMC/PCSK1/LEPR Heterozygous Cohort | 33 | |
| Overall Study | STARTED | POMC/PCSK1/LEPR Composite Heterozygous Cohort | 5 | |
| Overall Study | STARTED | POMC/PCSK1/LEPR Compound Heterozygous Cohort | 27 | |
| Overall Study | STARTED | SH2B1 Cohort | 22 | |
| Overall Study | STARTED | SMS Cohort | 12 | |
| Overall Study | STARTED | SRC1 Cohort | 32 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events3,680
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Skin Hyperpigmentation | Skin and subcutaneous tissue disorders | 16p11.2 Cohort | 17 | 19 | |
| other | Skin Hyperpigmentation | Skin and subcutaneous tissue disorders | AS Cohort | 3 | 4 | |
| other | Skin Hyperpigmentation | Skin and subcutaneous tissue disorders | BBS Cohort | 8 | 10 | |
| other | Skin Hyperpigmentation | Skin and subcutaneous tissue disorders | MC4R Cohort | 40 | 49 | |
| other | Skin Hyperpigmentation | Skin and subcutaneous tissue disorders | POMC/PCSK1/LEPR Heterozygous Cohort | 19 | 33 | |
| other | Skin Hyperpigmentation | Skin and subcutaneous tissue disorders | POMC/PCSK1/LEPR Composite Heterozygous Cohort | 3 | 5 | |
| other | Skin Hyperpigmentation | Skin and subcutaneous tissue disorders | POMC/PCSK1/LEPR Compound Heterozygous Cohort | 21 | 27 | |
| other | Skin Hyperpigmentation | Skin and subcutaneous tissue disorders | SH2B1 Cohort | 16 | 22 | |
| other | Skin Hyperpigmentation | Skin and subcutaneous tissue disorders | SMS Cohort | 10 | 12 | |
| other | Skin Hyperpigmentation | Skin and subcutaneous tissue disorders | SRC1 Cohort | 23 | 32 |
1 to 10 of 3,680Source ClinicalTrials.gov
See all 3,680 adverse eventsAdverse event totals30
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 16p11.2 Cohort | 0 | 19 |
| Total, all-cause mortality | AS Cohort | 0 | 4 |
| Total, all-cause mortality | BBS Cohort | 0 | 10 |
| Total, all-cause mortality | MC4R Cohort | 1 | 49 |
| Total, all-cause mortality | POMC/PCSK1/LEPR Heterozygous Cohort | 0 | 33 |
| Total, all-cause mortality | POMC/PCSK1/LEPR Composite Heterozygous Cohort | 0 | 5 |
| Total, all-cause mortality | POMC/PCSK1/LEPR Compound Heterozygous Cohort | 0 | 27 |
| Total, all-cause mortality | SH2B1 Cohort | 0 | 22 |
| Total, all-cause mortality | SMS Cohort | 0 | 12 |
| Total, all-cause mortality | SRC1 Cohort | 0 | 32 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03013543
GET https://conductscience.org/api/trials/v1/NCT03013543/results?page=2