CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 52 enrolled
Drug / intervention
Setmelanotide +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03746522
NCT03746522Phase 3Completed
CompareCT.gov

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

Rhythm Pharmaceuticals, Inc.·interventional·Posted Nov 19, 2018·Updated Dec 1, 2023

In Brief

A Phase 3 clinical trial evaluating Setmelanotide and Placebo for Bardet Biedl Syndrome (BBS) and Alström Syndrome (AS). Completed, enrolled 52 participants across 12 sites in 6 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBardet Biedl Syndrome (BBS), Alström Syndrome (AS)
CountriesCanada, France, Puerto Rico, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedNov 19, 2018
Enrollment StartNov 23, 2018
Primary CompletionNov 16, 2020
Study CompletionMar 8, 2021
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 7.6 years ago

Interventions

Setmelanotidedrug

SC injection of setmelanotide

Placebodrug

SC injection of placebo