Trials / Completed
CompletedNCT03746522
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 Trial of Setmelanotide (RM-493), a Melanocortin-4 Receptor (MC4R) Agonist, in Bardet-Biedl Syndrome (BBS) and Alström Syndrome (AS) Patients With Moderate to Severe Obesity
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 52 (actual)
- Sponsor
- Rhythm Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 6 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
Eligible participants will enter a 14-week, randomized, double-blind, placebo-controlled treatment period (Period 1) that will be followed by a 38-week open-label treatment period (Period 2) in which all participants will receive setmelanotide. Following Period 2, participants will continue receiving open-label setmelanotide for 14 weeks (Period 3), after which they could enroll into a separate treatment extension study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Setmelanotide | SC injection of setmelanotide |
| DRUG | Placebo | SC injection of placebo |
Timeline
- Start date
- 2018-11-23
- Primary completion
- 2020-11-16
- Completion
- 2021-03-08
- First posted
- 2018-11-19
- Last updated
- 2023-12-01
- Results posted
- 2023-12-01
Locations
12 sites across 6 countries: United States, Canada, France, Puerto Rico, Spain, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03746522. Inclusion in this directory is not an endorsement.