Setmelanotide for Obesity

Recruiting at 12 trial locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Rhythm Pharmaceuticals, Inc.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This is an open-label extension study designed to evaluate the long-term safety and tolerability of continued setmelanotide treatment in male and female patients ≥2 years of age who have completed or transitioned from a previous study with setmelanotide for rare genetic, syndromic, or acquired diseases of obesity upstream of the MC4R pathway.

Research Team

David Meeker, MD

Principal Investigator

Rhythm Pharmaceuticals, Inc.

Eligibility Criteria

This trial is for males and females aged 2 years or older who have obesity due to rare genetic, syndromic, or acquired conditions affecting the MC4R pathway. Participants must have previously completed or transitioned from a setmelanotide study.

Inclusion Criteria

Agree to use a highly effective form of contraception and follow the study contraception requirements throughout study duration and for 90 days after

Demonstrated clinical benefit in the previous setmelanotide study, as determined by the Investigator

I am over 2 years old and have previously participated in a setmelanotide study.

Exclusion Criteria

Pregnant and/or breastfeeding women

I have experienced new or worsening depression with suicidal thoughts or behaviors.

Discontinuation from a previous setmelanotide study

Treatment Details

Interventions

• Setmelanotide (Melanocortin-4 Receptor Agonist)

Trial Overview The trial is testing the long-term safety and effectiveness of continued treatment with Setmelanotide, a medication aimed at treating obesity by targeting specific pathways related to weight regulation.

Participant Groups

Group I: Setelanotide (Open-label) Experimental Treatment 1 Intervention

Once daily (QD) subcutaneous injection of setmelanotide

Who Is Running the Clinical Trial?

Rhythm Pharmaceuticals, Inc.

Lead Sponsor

Trials

31

Recruited

10,400+