2 registrations that name setmelanotide as a study arm and are recruiting or about to, as ClinicalTrials.gov listed them on Oct 20, 2026. Read each listing for its full criteria and current status.
Kymata never assesses eligibility. Each listing names its own criteria; only its study team can say whether someone can join. Trial doses are given under the trial's monitoring and are not a schedule for anyone outside it.
Filter 2 registrations
Status
Phase
8US sites across 8 states
1
2 to 4
5 to 19
20 or more
All 2 registrations
RecruitingNCT06760546
A Trial of Setmelanotide in Patients With Congenital Hypothalamic Obesity (Sub-study of NCT05774756)
Phase 3
Rhythm Pharmaceuticals, Inc.
About 39 people
Started Sep 23, 2025
In plain words A Phase 3 study of setmelanotide in people 4 and older, run by Rhythm Pharmaceuticals, Inc.. It plans to enroll about 39 people at 11 sites, 8 of them in the US.
Diagnosis of multiple pituitary hormone deficiency (MPHD), or septo-optic dysplasia (SOD), or optic nerve hypoplasia (ONH), or Childhood-onset combined pituitary hormone deficiency (CPHD), or Pituitary Stalk Interruption Syndrome (PSIS)…
Age 4 years and older
Weight gain associated with the hypothalamic injury and a BMI of ≥30 kg/m2 for patients ≥18 years of age or BMI ≥95th percentile for age and sex for patients 4 to <18 years of age
Agree to use a highly effective form of contraception throughout the study and for 90 days after the study
12 more inclusion criteria and the exclusion criteria are on the listing.
What it tests, as registered
Setmelanotide; Placebo
Registered summary
This is a sub-study of Study RM-493-040 (NCT05774756). The goal of this sub-study is to learn how well Setmelanotide works to improve weight reduction, hunger, and quality of life in patients 4 years of age and older with congenital Hypothalamic Obesity (cHO). To determine how well setmelanotide works and how safe it is, patients with cHO will take a daily injection of either setmelanotide or placebo and complete trial assessments for up to 26 weeks on a therapeutic regimen.
Where, as registered
8 US sites in 8 states; also United Kingdom (3).
RecruitingNCT07674290
Real-World Effects of MC4R Agonist Therapy in BBS and Severe Genetic Obesity
Phase 4
Tom Hühne
About 200 people
Started Jan 1, 2023
In plain words A Phase 4 study of setmelanotide in people of any age, run by Tom Hühne. It plans to enroll about 200 people at 1 site, none in the US.
Who it lists and where
Who the trial lists, as registered
Lists people of any age. Conditions: Bardet Biedl Syndrome (BBS); Bardet Biedl Syndrome; Bardet-Biedl Syndrome (BBS); Alstrom Syndrome.
clinical phenotype corresponding to Bardet-Biedl Syndrome
genetic testing with notable finding
The exclusion criteria are on the listing.
What it tests, as registered
Setmelanotide
Registered summary
Bardet-Biedl syndrome (BBS) and other rare disorders associated with impairment of the melanocortin-4 receptor (MC4R) pathway are characterized by severe early-onset obesity, hyperphagia, and substantial morbidity. Setmelanotide, an MC4R agonist, is approved in Europe for selected genetic obesity disorders and reimbursed in Germany for eligible patients. This study aims to evaluate the effectiveness, safety, treatment persistence, metabolic outcomes, and patient-reported outcomes of Setmelanotide under real-world conditions. The full summary is on the listing.