Current partner codePEPTIDESDE
NCT06596135·Phase 3·INTERVENTIONAL

Open-Label Extension Study of Setmelanotide

Status

Completed

Phase

Phase 3

Enrollment

28

Locations

13

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

Setmelanotide

Open-label daily injections of setmelanotide

Timeline

From registration to results.

  1. First posted

    Sep 19, 2024

  2. Study start

    Oct 21, 2024

  3. Primary completion

    Jun 24, 2026

  4. Study completion

    Jun 24, 2026

  5. Results posted

    Not reported

  6. Registry updated

    Jul 15, 2026

Outcomes

What the study measures.

Primary outcomes

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

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
2 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

Key Inclusion Criteria: * Males and females ≥2 years of age who have completed a previous setmelanotide clinical study and who have a condition or indication for which Rhythm plans further clinical development. * 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. Key Exclusion Criteria: * Any gene variant, syndromic, or acquired disease for which setmelanotide is currently approved in the United States (i.e., patients eligible for commercial setmelanotide (IMCIVREE®). * Any new or worsening depression resulting in suicidal thoughts and/or behaviors. * Discontinuation from a previous setmelanotide study. * History or close family history (parents or siblings) of melanoma. * Pregnant and/or breastfeeding women Other protocol defined Inclusion/Exclusion criteria may apply.

Study locations

13 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

HonorHealth Research Institute

Scottsdale, Arizona, United States

UC San Diego- Rady Children's Hospital

San Diego, California, United States

University of Florida at Gainesville

Gainesville, Florida, United States

University of Michigan

Ann Arbor, Michigan, United States

Mayo Clinic - Rochester

Rochester, Minnesota, United States

Children's Minnesota

Saint Paul, Minnesota, United States

University of Buffalo

Getzville, New York, United States

M3 Wake Research, Inc

Raleigh, North Carolina, United States

Geisinger Health System

Danville, Pennsylvania, United States

WR-ClinSearch

Chattanooga, Tennessee, United States

Vanderbilt University School of Medicine

Nashville, Tennessee, United States

Seattle Children's Research Institute

Seattle, Washington, United States

Marshfield Clinical Research Institute

Marshfield, Wisconsin, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Setmelanotide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.