Setmelanotide for Obesity

Palo Alto (17 mi)

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.

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.

Exclusion Criteria

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

I have a condition treatable with setmelanotide (IMCIVREE®).

My family (parents or siblings) or I have a history of melanoma.

Treatment Details

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.

1Treatment groups

Experimental Treatment

Group I: Setelanotide (Open-label)Experimental Treatment1 Intervention

Once daily (QD) subcutaneous injection of setmelanotide