CompletedPhase 2/3

Long Term Extension Trial of Setmelanotide

United States205 participantsStarted 2018-07-15

Plain-language 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.

Who can participate

Age range2 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

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

What they're measuring

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

Timeframe: From first dose up to 5.6 years

Trial details

NCT IDNCT03651765

SponsorRhythm Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-01-09

Results submitted2025-05-20

View on ClinicalTrials.gov More Obesity Associated With Defects in Leptin-melanocortin Pathway trials