MedTrace Logo

Setmelanotide (RM-493), Melanocortin-4 Receptor (MC4R) Agonist, in Bardet-Biedl Syndrome (BBS) and Alström Syndrome (AS) Participants With Moderate to Severe Obesity

NCT03746522 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2023-12-01

Study results available
· View outcomes & findings →

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.

Conditions

  • Bardet Biedl Syndrome (BBS)
  • Alström Syndrome (AS)

Interventions

DRUG

Setmelanotide

SC injection of setmelanotide

DRUG

Placebo

SC injection of placebo

Sponsors & Collaborators

  • Rhythm Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • David Meeker, MD · Rhythm Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-23
Primary Completion
2020-11-16
Completion
2021-03-08
FDA Drug
Yes

Countries

  • United States
  • Canada
  • France
  • Puerto Rico
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03746522 on ClinicalTrials.gov