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Long Term Extension Trial of Setmelanotide

NCT03651765 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 205

Last updated 2025-05-31

Study results available
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Summary

This was a long-term extension trial to study the safety and tolerability of continued setmelanotide treatment in participants who had completed a previous clinical trial on treatment with setmelanotide for obesity associated with genetic defects upstream of the Melanocortin-4 (MC4) receptor in the leptin-melanocortin pathway.

Conditions

  • Obesity Associated With Defects in Leptin-melanocortin Pathway

Interventions

DRUG

Setmelanotide

Once daily subcutaneous injection

Sponsors & Collaborators

  • Rhythm Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • David Meeker, MD · Rhythm Pharmaceuticals, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-15
Primary Completion
2025-01-09
Completion
2025-01-09
FDA Drug
Yes

Countries

  • United States
  • Canada
  • France
  • Germany
  • Greece
  • Netherlands
  • 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 NCT03651765 on ClinicalTrials.gov