CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 164 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/NCT04963231
NCT04963231Phase 2Completed
CompareCT.gov

A 2-Stage (Open-Label Followed by Randomized Double-Blind, Placebo-Controlled Stage), Phase 2 Trial of Setmelanotide in Patients With Specific Gene Variants in the Melanocortin-4 Receptor Pathway

Rhythm Pharmaceuticals, Inc.·interventional·Posted Jul 15, 2021·Updated Jul 2, 2025

In Brief

A Phase 2 clinical trial evaluating Setmelanotide and Placebo for Genetic Obesity. Completed, enrolled 164 participants across 36 sites in 8 countries.

Detailed Summary

The purpose of this study was to evaluate the safety and efficacy of once daily subcutaneous (SC) administration of setmelanotide in participants with obesity and specific gene variants in the MC4R pathway.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGenetic Obesity
CountriesCanada, Germany, Greece, Israel, Netherlands, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedJul 15, 2021
Enrollment StartNov 30, 2021
Primary CompletionAug 4, 2023
Study CompletionSep 30, 2024
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 5.0 years ago

Interventions

Setmelanotidedrug

SC injection

Placebodrug

SC injection