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NCT03746522 · ClinicalTrials.gov registry record · Phase 3
Setmelanotide (RM-493), Melanocortin-4 Receptor (MC4R) Agonist, in Bardet-Biedl Syndrome (BBS) and Alström Syndrome (AS) Participants With Moderate to Severe Obesity
A Phase 3 study, sponsored by Rhythm Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 52
- Enrollment target
NCT03746522: Completed Phase 3 study, sponsored by Rhythm Pharmaceuticals.
NCT03746522 is a Phase 3 study that has completed, run by Rhythm Pharmaceuticals. The registered enrollment target is 52 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03746522, a Phase 3 study, has completed, sponsored by Rhythm Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 52 participants
- Enrollment target
Study Summary
This pivotal, phase 3 study is designed to confirm the efficacy and safety of setmelanotide, a potent melanocortin receptor type 4 (MC4R) agonist, for the treatment of obesity and hyperphagia in participants with Bardet Biedl syndrome (BBS) or Alström syndrome (AS). The study's primary efficacy endpoint is to evaluate the proportion of participants (≥ 12 years of age at baseline) who lose ≥ 10% of their baseline body weight following approximately (\~) 52 weeks of treatment with setmelanotide compared to a historical control rate.
Primary Outcome
The percentage of participants (≥12 years of age at baseline) who achieved a ≥10% reduction from baseline in body weight at Period 2 or after 52 weeks of treatment with setmelanotide were analyzed. There was a 14-week placebo-controlled period at the beginning of the trial. After completion of the placebo-controlled period, all participants from the placebo group switched to setmelanotide treatment. The placebo group was integrated into the 52-week analysis so that the participants who received
Interventions
- DRUG Placebo
- DRUG Setmelanotide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2018-11-23 |
| Est. Completion | 2021-03-08 |
| Phase | Phase 3 |
What the finished NCT03746522 record still lists
NCT03746522 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03746522 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03746522 about?
NCT03746522 is a clinical study titled "Setmelanotide (RM-493), Melanocortin-4 Receptor (MC4R) Agonist, in Bardet-Biedl Syndrome (BBS) and Alström Syndrome (AS) Participants With Moderate to Severe Obesity". This pivotal, phase 3 study is designed to confirm the efficacy and safety of setmelanotide, a potent melanocortin receptor type 4 (MC4R) agonist, for the treatment of obesity and hyperphagia in participants with Bardet Biedl syndrome (BBS) or Alström syndrome (AS). The study's primary efficacy endp...
What is the current status of trial NCT03746522?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 52 participants. The study started on 2018-11-23. Estimated completion is 2021-03-08.
What interventions are being tested in trial NCT03746522?
The interventions under investigation include: Placebo (DRUG), Setmelanotide (DRUG).
Who is sponsoring clinical trial NCT03746522?
This trial is sponsored by Rhythm Pharmaceuticals, which has 23 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03746522's enrollment target sits among peer trials
52 1841st of 2000 higher than 159 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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