Long Term Extension Trial of Setmelanotide

April 9, 2024 updated by: Rhythm Pharmaceuticals, Inc.

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2E1
        • University of Alberta
  • France
      • Paris, France, 75013
        • Hopital de la Pitie Salpetriere
      • Paris, France, 75012
        • Hôpital Trousseau
  • Germany
      • Berlin, Germany, 13354
        • Charité - Universitätsmedizin Berlin
      • Leipzig, Germany, 04103
        • University of Leipzig
      • Ulm, Germany, 89075
        • University of Ulm
  • Greece
      • Rio, Greece, 26504
        • University General Hospital of Patras
  • Netherlands
      • Rotterdam, Netherlands
        • Erasmus MC
  • Spain
      • Madrid, Spain, 65 28009
        • Universidad Autónoma de Madrid
  • United Kingdom
      • Birmingham, United Kingdom, B15 2GW
        • University Hospitals Birmingham NHS Foundation Trust
      • Cambridge, United Kingdom, CB2 0QQ
        • Wellcome Trust-MRC Institute of Metabolic Science
      • London, United Kingdom, W12 0NN
        • Hammersmith Hospital
  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Synexus Clinical Research US, Inc. - Phoenix Southeast
      • Scottsdale, Arizona, United States, 85258
        • Honor Health Research Institute
    • California
      • San Diego, California, United States, 92108
        • San Diego Wake Research
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida College of Medicine
    • Massachusetts
      • Springfield, Massachusetts, United States, 01107
        • Baystate Medical Center
    • New York
      • Buffalo, New York, United States, 14203
        • University at Buffalo
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke University Medical Center
      • Raleigh, North Carolina, United States, 27612
        • Wake Research
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822-2607
        • Obesity Institute, Geisinger Clinic
      • Philadelphia, Pennsylvania, United States, 19104
        • Childrens Hospital of Philadephia
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Synexus Clinical Research US, Inc.- Primary Care Associates, PC
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • Wake Research TN
      • Nashville, Tennessee, United States, 37212
        • Vanderbilt University Medical Center
    • Washington
      • Seattle, Washington, United States, 98101
        • Seattle Children's Research Institute
    • Wisconsin
      • Marshfield, Wisconsin, United States, 54449
        • Marshfield Clinic Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Setmelanotide
Once daily subcutaneous injection
Drug: Setmelanotide
Once daily subcutaneous injection
Other Names:
  • RM-493

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and tolerability of setmelanotide
Time Frame: 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.
7 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rhythm Pharmaceuticals, Inc.

Investigators

  • Study Chair: David Meeker, MD, Rhythm Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2018

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

January 18, 2018

First Submitted That Met QC Criteria

August 27, 2018

First Posted (Actual)

August 29, 2018

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RM-493-022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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