Long Term Extension Trial of Setmelanotide

Obesity Associated With Defects in Leptin-melanocortin Pathway Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03651765
• Other study ID #: RM-493-022
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: July 15, 2018
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Rhythm Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a long-term extension trial to study the safety and tolerability of continued setmelanotide treatment in patients who have completed a previous clinical trial on treatment with setmelanotide for obesity associated with genetic defects upstream of the MC4 receptor in the leptin-melanocortin pathway.

Description:

The primary objectives of this extension trial are to explore the long-term safety and tolerability of setmelanotide for up to 5 years or until drug is otherwise available through authorized use. Patients can enter this protocol immediately upon completion of their index protocol such that dosing of setmelanotide continues without gaps in therapy.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

Key Inclusion Criteria:

1. Patients aged 2 or older (or aged >2 years as per local regulations) who have completed participation in a previous setmelanotide trial and demonstrated adequate safety and meaningful clinical benefit (efficacy)

2. Patient and/or parent or guardian is able to communicate with the investigator, understand and sign the written informed consent/assent, and comply with the trial requirements

3. Agree to use a highly effective form of contraception throughout the trial

Key Exclusion Criteria:

1. Pregnant and/or breastfeeding women

2. Significant dermatologic findings relating to melanoma or pre-melanoma skin lesions (excluding non-invasive basal or squamous cell lesion)

3. Current, clinically significant disease

4. Documented diagnosis of schizophrenia, bipolar disorder, personality disorder, major depressive disorder, or other psychiatric disorder(s)

5. Suicidal ideation, attempt or behavior

6. History of significant liver disease

7. Moderate to severe renal dysfunction as defined by a glomerular filtration rate (GFR) <30 mL/min.

8. History or close family history of melanoma or patient history of oculocutaneous albinism Other protocol defined Inclusion/Exclusion criteria may apply.

Related Conditions & MeSH terms

• Obesity
• Obesity Associated With Defects in Leptin-melanocortin Pathway

Intervention

Drug:
• Setmelanotide
Once daily subcutaneous injection

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta
France	Hôpital de la Pitié Salpêtrière	Paris
France	Hôpital Trousseau	Paris
Germany	Charité - Universitätsmedizin Berlin	Berlin
Germany	University of Leipzig	Leipzig
Germany	University of Ulm	Ulm
Greece	University General Hospital of Patras	Rio
Netherlands	Erasmus MC	Rotterdam
Spain	Universidad Autónoma de Madrid	Madrid
United Kingdom	University Hospitals Birmingham NHS Foundation Trust	Birmingham
United Kingdom	Wellcome Trust-MRC Institute of Metabolic Science	Cambridge
United Kingdom	Hammersmith Hospital	London
United States	Synexus Clinical Research US, Inc.- Primary Care Associates, PC	Anderson	South Carolina
United States	University at Buffalo	Buffalo	New York
United States	Synexus Clinical Research US, Inc. - Phoenix Southeast	Chandler	Arizona
United States	Wake Research TN	Chattanooga	Tennessee
United States	Obesity Institute, Geisinger Clinic	Danville	Pennsylvania
United States	Duke University Medical Center	Durham	North Carolina
United States	University of Florida College of Medicine	Gainesville	Florida
United States	Marshfield Clinic Research Institute	Marshfield	Wisconsin
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Childrens Hospital of Philadephia	Philadelphia	Pennsylvania
United States	Wake Research	Raleigh	North Carolina
United States	San Diego Wake Research	San Diego	California
United States	Honor Health Research Institute	Scottsdale	Arizona
United States	Seattle Children's Research Institute	Seattle	Washington
United States	Baystate Medical Center	Springfield	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Rhythm Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Canada,  France,  Germany,  Greece,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability of setmelanotide	Frequency and severity of adverse events (AEs) as well as changes in physical examinations, electrocardiograms (ECGs), vital signs (including resting BP and HR), laboratory evaluations, and injection site reactions.	7 years