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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 is a Phase 3 study that has completed, run by Rhythm Pharmaceuticals. The registered enrollment target is 52 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03746522
The ClinicalTrials.gov registry entry for NCT03746522 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rhythm Pharmaceuticals, which has 23 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03746522 reports 0 study locations.
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.
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