Long Term Extension Trial of Setmelanotide
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ClinicalTrials.gov Identifier: NCT03651765 |
Recruitment Status :
Enrolling by invitation
First Posted : August 29, 2018
Last Update Posted : April 5, 2023
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Condition or disease | Intervention/treatment | Phase |
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Obesity Associated With Defects in Leptin-melanocortin Pathway | Drug: Setmelanotide | Phase 2 Phase 3 |
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 |

Arm | Intervention/treatment |
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Experimental: Setmelanotide
Once daily subcutaneous injection
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Drug: Setmelanotide
Once daily subcutaneous injection
Other Name: RM-493 |
- 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.

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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 |
Key Inclusion Criteria:
- 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)
- 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
- Agree to use a highly effective form of contraception throughout the trial
Key Exclusion Criteria:
- Pregnant and/or breastfeeding women
- Significant dermatologic findings relating to melanoma or pre-melanoma skin lesions (excluding non-invasive basal or squamous cell lesion)
- Current, clinically significant disease
- Documented diagnosis of schizophrenia, bipolar disorder, personality disorder, major depressive disorder, or other psychiatric disorder(s)
- Suicidal ideation, attempt or behavior
- History of significant liver disease
- Moderate to severe renal dysfunction as defined by a glomerular filtration rate (GFR) <30 mL/min.
- History or close family history of melanoma or patient history of oculocutaneous albinism
Other protocol defined Inclusion/Exclusion criteria may apply.

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

Study Chair: | David Meeker, MD | Rhythm Pharmaceuticals, Inc. |
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
setmelanotide RM-493 obesity leptin-melanocortin melanocortin 4 receptor |
Obesity Overweight Overnutrition Nutrition Disorders Body Weight |