Actively Recruiting
A Trial of Setmelanotide in Patients With Congenital Hypothalamic Obesity (Sub-study of NCT05774756)
Led by Rhythm Pharmaceuticals, Inc. · Updated on 2026-02-12
39
Participants Needed
11
Research Sites
128 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Trial of Setmelanotide in Patients With Congenital Hypothalamic Obesity (Sub-study of NCT05774756)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of multiple pituitary hormone deficiency, septo-optic dysplasia, optic nerve hypoplasia, childhood-onset combined pituitary hormone deficiency, or pituitary stalk interruption syndrome with at least one pituitary deficiency
- Body mass index (BMI) 6530 kg/m2 for patients 18 years and older
- BMI at or above the 95th percentile for age and sex for patients aged 4 to under 18 years
- Age 4 years and older
- Weight gain associated with hypothalamic injury and a BMI of 6530 kg/m2 for patients 18 years and older or BMI at or above the 95th percentile for age and sex for patients 4 to under 18 years
- Agree to use a highly effective form of contraception throughout the study and for 90 days after the study
You will not qualify if you...
- Diagnosis of Prader-Willi syndrome or ROHHADNET
- Weight loss greater than 2% in the previous 3 months for patients 18 years and older or greater than 2% reduction in BMI for patients aged 4 to under 18 years
- Bariatric surgery or procedure within the last 2 years
- Diagnosis of severe psychiatric disorders or any suicidal ideation, attempt, or behavior
- Current clinically significant pulmonary, cardiac, metabolic, or oncologic disease
- Significant dermatologic findings related to melanoma or pre-melanoma skin lesions (excluding non-invasive basal or squamous cell lesions)
- History or close family history of skin cancer or melanoma
- Participation in any clinical trial with an investigational drug/device within 3 months prior to the first trial dose
- Previous enrollment in a clinical trial involving setmelanotide or any previous exposure to setmelanotide
- Inability to comply with once daily injection regimen
- Female participants who are pregnant or breastfeeding
- If receiving hormone replacement therapy, dose must have been stable for at least 2 months before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
University of Alabama
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
3
Lurie Children's Hospital
Chicago, Illinois, United States, 60611
Actively Recruiting
4
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
5
Children's Minnesota
Saint Paul, Minnesota, United States, 55102
Actively Recruiting
6
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
7
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
8
Seattle Children's Research Institute
Seattle, Washington, United States, 98105
Actively Recruiting
9
UCL Great Ormond Street Institute of Child Health
London, Greater London, United Kingdom, WC1N 1EH
Actively Recruiting
10
Birmingham Women and Children's Hospital NHS Trust
Birmingham, West Midlands, United Kingdom, B46NH
Actively Recruiting
11
Hull Royal Infirmary
Hull, United Kingdom, HU32RW
Actively Recruiting
Research Team
R
Rhythm Clinical Trials
CONTACT
P
Physician Inquiry Clinical Trials
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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