Long Term Extension Trial of Setmelanotide

Phase 2

Active, not recruiting

• Conditions: Obesity Associated With Defects in Leptin-melanocortin Pathway
• Interventions: Drug: Setmelanotide

• Registration Number: NCT03651765
• Lead Sponsor: Rhythm Pharmaceuticals, Inc.

Brief 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.

Detailed 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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2018-01-18
• Study Start: 2018-07-15
• Study First Submitted QC: 2018-08-27
• Study First Posted: 2018-08-29
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-25
• Last Update Posted: 2024-10-28
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 300

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Setmelanotide	Setmelanotide	Once daily subcutaneous injection

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of setmelanotide	7 years	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.

Trial Locations

Locations (27)

Obesity Institute, Geisinger Clinic; 🇺🇸 Danville, Pennsylvania, United States

Wake Research; 🇺🇸 Raleigh, North Carolina, United States

Wake Research TN; 🇺🇸 Chattanooga, Tennessee, United States

Synexus Clinical Research US, Inc. - Phoenix Southeast; 🇺🇸 Chandler, Arizona, United States

Honor Health Research Institute; 🇺🇸 Scottsdale, Arizona, United States

University of Ulm; 🇩🇪 Ulm, Germany

Synexus Clinical Research US, Inc.- Primary Care Associates, PC; 🇺🇸 Anderson, South Carolina, United States

Hôpital de la Pitié Salpêtrière; 🇫🇷 Paris, France

Hôpital Trousseau; 🇫🇷 Paris, France

University of Leipzig; 🇩🇪 Leipzig, Germany

Childrens Hospital of Philadephia; 🇺🇸 Philadelphia, Pennsylvania, United States

University at Buffalo; 🇺🇸 Buffalo, New York, United States

Marshfield Clinic Research Institute; 🇺🇸 Marshfield, Wisconsin, United States

Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany

Hammersmith Hospital; 🇬🇧 London, United Kingdom

University General Hospital of Patras; 🇬🇷 Rio, Greece

University Hospitals Birmingham NHS Foundation Trust; 🇬🇧 Birmingham, United Kingdom

Wellcome Trust-MRC Institute of Metabolic Science; 🇬🇧 Cambridge, United Kingdom

Universidad Autónoma de Madrid; 🇪🇸 Madrid, Spain

Erasmus MC; 🇳🇱 Rotterdam, Netherlands

San Diego Wake Research; 🇺🇸 San Diego, California, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

Seattle Children's Research Institute; 🇺🇸 Seattle, Washington, United States

University of Alberta; 🇨🇦 Edmonton, Alberta, Canada

University of Florida College of Medicine; 🇺🇸 Gainesville, Florida, United States

Baystate Medical Center; 🇺🇸 Springfield, Massachusetts, United States