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Long Term Extension Trial of Setmelanotide

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03651765
Recruitment Status : Enrolling by invitation
First Posted : August 29, 2018
Last Update Posted : April 5, 2023
Sponsor:
Information provided by (Responsible Party):
Rhythm Pharmaceuticals, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Obesity Associated With Defects in Leptin-melanocortin Pathway Drug: Setmelanotide Phase 2 Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Open label treatment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 15, 2018
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Setmelanotide
Once daily subcutaneous injection
 Drug: Setmelanotide
Once daily subcutaneous injection
Other Name: RM-493


Outcome Measures
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Primary Outcome Measures :
  1. Safety and tolerability of setmelanotide [ Time Frame: 5 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03651765


Locations
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Sponsors and Collaborators
Rhythm Pharmaceuticals, Inc.
Investigators
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Study Chair: David Meeker, MD Rhythm Pharmaceuticals, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Rhythm Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03651765    
Other Study ID Numbers: RM-493-022
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: April 5, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rhythm Pharmaceuticals, Inc.:
setmelanotide
RM-493
obesity
leptin-melanocortin
melanocortin 4 receptor
Additional relevant MeSH terms:
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Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight