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Completed Phase 2 Interventional Results available

Phase 2 Trial to Evaluate Safety and Efficacy of Setmelanotide (RM-493) in Obese Participants With Prader-Willi Syndrome

ClinicalTrials.gov ID: NCT02311673

Public ClinicalTrials.gov record NCT02311673. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 22, 2026, 12:44 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 2, Randomized, Double-Blind, Placebo-controlled Pilot Study to Assess the Effects of RM-493, a Melanocortin 4 Receptor (MC4R) Agonist, in Obese Subjects With Prader-Willi Syndrome (PWS) on Safety, Weight Reduction, and Food-Related Behaviors

Study identification

NCT ID
NCT02311673
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Rhythm Pharmaceuticals, Inc.
Industry
Enrollment
40 participants

Conditions and interventions

Interventions

  • Setmelanotide Drug
  • Placebo Drug

Drug

Eligibility (public fields only)

Age range
16 Years to 65 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 18, 2015
Primary completion
Oct 25, 2016
Completion
Oct 25, 2016
Last update posted
Jul 26, 2023

2015 – 2016

United States locations

U.S. sites
5
U.S. states
5
U.S. cities
5
Facility City State ZIP Site status
University of California Irvine Irvine California 92617
University of Florida Gainesville Florida 32610
Kansas University Medical Center Kansas City Kansas 66160
Winthrop University Hospital Mineola New York 11501
Vanderbilt University Nashville Tennessee 37203

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT02311673, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 26, 2023 · Synced Jul 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT02311673 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →