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Setmelanotide Phase 2 Treatment Trial in Participants With Rare Genetic Disorders of Obesity

NCT03013543 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 213

Last updated 2023-08-18

Study results available
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Summary

The purpose of the study was to determine the effect of setmelanotide (RM-493) on weight, hunger assessments, and other factors in participants with rare genetic disorders of obesity.

Conditions

  • Genetic Obesity
  • Obesity
  • Obesity Due to Melanocortin 4 Receptor Deficiency

Interventions

DRUG

Setmelanotide

RM-493 QD SC injection

Sponsors & Collaborators

  • Rhythm Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • David Meeker, MD · Rhythm Pharmaceuticals, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-10
Primary Completion
2022-03-01
Completion
2022-03-01
FDA Drug
Yes

Countries

  • United States
  • Canada
  • France
  • Germany
  • Greece
  • Israel
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT03013543 on ClinicalTrials.gov