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RecruitingPhase 3

A Trial of Setmelanotide in Patients With Congenital Hypothalamic Obesity (Sub-study of NCT05774756)

Rhythm Pharmaceuticals, Inc. · NCT06760546

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 4+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
39
US sites recruiting
8
Study start
September 23, 2025
Record last updated
February 12, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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.

Being studied: Setmelanotide; Placebo

Conditions: Hypothalamic Obesity; Multiple Pituitary Hormone Deficiency Genetic Form; Septo-Optic Dysplasia; Optic Nerve Hypoplasia; Childhood-onset Combined Pituitary Hormone Deficiency; Pituitary Stalk Interruption Syndrome

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Key Inclusion Criteria

  • 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) with at least one pituitary deficiency AND a body mass index (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
  • 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

Key Exclusion Criteria

  • Diagnosis of Prader-Willi syndrome (PWS) or Rapid-onset obesity with hypoventilation, hypothalamic, autonomic dysregulation, neuroendocrine tumor syndrome (ROHHADNET)
  • Weight loss >2% in the previous 3 months for patients aged ≥18 years or >2% reduction in BMI for patients aged 4 to \<18 years
  • Bariatric surgery or procedure within last 2 years
  • Diagnosis of severe psychiatric disorders; any suicidal ideation, attempt or behavior
  • Current, clinically significant pulmonary, cardiac, metabolic, or oncologic disease
  • Significant dermatologic findings relating to melanoma or pre-melanoma skin lesions (excluding non-invasive basal or squamous cell lesion)
  • 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
  • Previously enrolled in a clinical trial involving setmelanotide or any previous exposure to setmelanotide
  • Inability to comply with once daily (QD) injection regimen
  • If female, pregnant and/or breastfeeding.
  • If receiving hormone replacement therapy, dose has remained stable for at least 2 months before Screening

Other protocol defined Inclusion/Exclusion criteria may apply.

Recruiting US locations

Study contacts (from the official record)

  • Rhythm Clinical Trials · (857) 264-4280 · clinicaltrials@rhythmtx.com
  • Physician Inquiry Clinical Trials · (857) 264-4280 · clinicaltrials@rhythmtx.com
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A Trial of Setmelanotide in Patients With Congenital Hypothalamic… (NCT06760546) | Bored Studies