Trial · Interventional

CompletedPhase 2/3Results postedRegistry data

Long Term Extension Trial of Setmelanotide

NCTNCT03651765Other idRM-493-022Other id2017-005006-35Other id2017

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 2/3
Enrollment: 205 participants (actual)
Sponsor: Rhythm Pharmaceuticals, Inc. · Industry
Design: Allocation not applicable · Open label (no masking)
Countries: 8 countries
United States, Canada, France, Germany, Greece, Netherlands, Spain, United Kingdom
Start: 15 Jul 2018
Primary completion: 9 Jan 2025
Completion: 9 Jan 2025
First posted: 29 Aug 2018
Last update posted: 31 May 2025
Conditions: Obesity Associated With Defects in Leptin-melanocortin Pathway

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20182020202220242026

Ph 2/3
Long Term Extension Trial of Setmelanotide
NCT03651765
15 Jul 2018 to 9 Jan 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

SetmelanotideDrug

Arms1

Experimental
Setmelanotide
Participants received setmelanotide at the same starting dose as received in the index trials as a Subcutaneous (SC) injection once daily for up to 5.6 years in this extension trial.

Primary outcomes1

Outcomes the sponsor listed as primary.

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame · From first dose up to 5.6 years
Registry description
An adverse event (AE) was any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A TEAE was defined as any AE that began or worsened in intensity on or after the date of the first administration of study drug.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· From first dose up to 5.6 years

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

Group	Value (Participants)
Setmelanotide	198

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
SetmelanotideParticipants received setmelanotide at the same starting dose as received in the index trials as a SC injection once daily for up to 5.6 years in this extension trial.	0 / 205	27 / 205	198 / 205

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Clinical trial · 2024

11 results

Setmelanotide for the treatment of acquired hypothalamic obesity: a phase 2, open-label, multicentre trial.

Roth et al. 2024The lancet. Diabetes & endocrinologycited by 62

PMID 38697184DOI 10.1016/s2213-8587(24)00087-1PUB-38697184

Full text at the publisher11 results

Publisher page See results (11)

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

DerivedMeyer JR, Krentz AD, Berg RL, Richardson JG, Pomeroy J, Hebbring SJ, Haws RM. Kidney failure in Bardet-Biedl syndrome. Clin Genet. 2022 Apr;101(4):429-441. doi: 10.1111/cge.14119. PMID 35112343

Eligibility

Who could join, as posted.

Sex: All
Age: from 2 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Key Inclusion Criteria: 1. 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) 2. 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 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 milliliters per minute (mL/min). 8. History or close family history of melanoma or participant history of oculocutaneous albinism Other protocol defined Inclusion/Exclusion criteria may apply.

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