Open-Label Extension Study of Setmelanotide

Conditions

• Obesity Associated With Defects in Leptin-melanocortin Pathway

Eligibility Criteria

Sex

ALL

Age

2 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Setmelanotide — DRUG
  Open-label daily injections of setmelanotide

Study Details

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.

Key Dates

Start date

Oct 21, 2024

Status verified

Sep 2025

Primary completion

Oct 30, 2027

Completion

Oct 30, 2027

Study Design

Enrollment

30 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Setelanotide (Open-label)
  Once daily (QD) subcutaneous injection of setmelanotide

Primary Outcome Measure

Safety and tolerability of setmelanotide assessed by frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to 3 years ]

Locations (13)

Find similar trials in Scottsdale, AZ