NCT03651765

Long Term Extension Trial of Setmelanotide

Long Term Extension Trial of Setmelanotide (RM-493) for Patients Who Have Completed a Trial of Setmelanotide for the Treatment of Obesity Associated With Genetic Defects Upstream of the MC4 Receptor in the Leptin-melanocortin Pathway

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 205 (actual)
• Sponsor: Rhythm Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The primary objectives of this extension trial were to explore the long-term safety and tolerability of setmelanotide for up to 7 years or until drug was otherwise available through authorized use. Participants entered this protocol immediately upon completion of their index protocol such that dosing of setmelanotide continued without gaps in therapy.

Conditions

• Obesity Associated With Defects in Leptin-melanocortin Pathway

Interventions

Type	Name	Description
DRUG	Setmelanotide	Once daily subcutaneous injection

Timeline

• Start date: 2018-07-15
• Primary completion: 2025-01-09
• Completion: 2025-01-09
• First posted: 2018-08-29
• Last updated: 2025-05-31
• Results posted: 2025-05-31

Locations

27 sites across 8 countries: United States, Canada, France, Germany, Greece, Netherlands, Spain, United Kingdom

Regulatory

• FDA-regulated drug study