Phase 3
Completed N=205
Long Term Extension Trial of Setmelanotide
Obesity Associated With Defects in Leptin-melanocortin Pathway
Source: ClinicalTrials.gov NCT03651765 ↗
Enrolled (actual)
205
Serious AEs
13.2%
Results posted
May 2025
Primary outcomePrimary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) — 198 Participants
◆ Published Evidence
Established
58citations · ~29 / year
Setmelanotide for the treatment of acquired hypothalamic obesity: a phase 2, open-label, multicentre trial.
Summary
This was a long-term extension trial to study the safety and tolerability of continued setmelanotide treatment in participants who had completed a previous clinical trial on treatment with setmelanotide for obesity associated with genetic defects upstream of the Melanocortin-4 (MC4) receptor in the leptin-melanocortin pathway.
Linked Publications (2)
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Setmelanotide for the treatment of acquired hypothalamic obesity: a phase 2, open-label, multicentre trial.
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Kidney failure in Bardet-Biedl syndrome.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
198 | — |
Eligibility Criteria
Key Inclusion Criteria
- Participants aged 2 or older (or aged >2 years as per local regulations) who had completed participation in a previous setmelanotide trial and demonstrated adequate safety and meaningful clinical benefit (efficacy)
- Participant and/or parent or guardian was 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 milliliters per minute (mL/min).
- History or close family history of melanoma or participant history of oculocutaneous albinism
Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT03651765) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.