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NCT06760546 | RECRUITING | Hypothalamic Obesity

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

Rhythm Pharmaceuticals, Inc.

Brief 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.

Condition or disease

Hypothalamic Obesity

Multiple Pituitary Hormone Deficiency Genetic Form

Septo-Optic Dysplasia

Optic Nerve Hypoplasia

Childhood-onset Combined Pituitary Hormone Deficiency

Pituitary Stalk Interruption Syndrome

Intervention/treatment

Setmelanotide

Placebo

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 39 participants
Masking : TRIPLE
Primary Purpose : TREATMENT
Official Title : A Phase 3, Double Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Setmelanotide in Patients With Acquired Hypothalamic Obesity
Actual Study Start Date : 2025-09-22
Estimated Primary Completion Date : 2027-01-30
Estimated Study Completion Date : 2027-01-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 4 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Key Inclusion Criteria
  • 1. 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
  • 2. Age 4 years and older
  • 3. 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
  • 4. Agree to use a highly effective form of contraception throughout the study and for 90 days after the study
  • Key Exclusion Criteria
    • 1. Diagnosis of Prader-Willi syndrome (PWS) or Rapid-onset obesity with hypoventilation, hypothalamic, autonomic dysregulation, neuroendocrine tumor syndrome (ROHHADNET)
    • 2. 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
    • 3. Bariatric surgery or procedure within last 2 years
    • 4. Diagnosis of severe psychiatric disorders; any suicidal ideation, attempt or behavior
    • 5. Current, clinically significant pulmonary, cardiac, metabolic, or oncologic disease
    • 6. Significant dermatologic findings relating to melanoma or pre-melanoma skin lesions (excluding non-invasive basal or squamous cell lesion)
    • 7. History or close family history of skin cancer or melanoma
    • 8. Participation in any clinical trial with an investigational drug/device within 3 months prior to the first trial dose
    • 9. Previously enrolled in a clinical trial involving setmelanotide or any previous exposure to setmelanotide
    • 10. Inability to comply with once daily (QD) injection regimen
    • 11. If female, pregnant and/or breastfeeding.
    • 12. If receiving hormone replacement therapy, dose has remained stable for at least 2 months before Screening
    • Other protocol defined Inclusion/Exclusion criteria may apply.
A Trial of Setmelanotide in Patients With Congenital Hypothalamic Obesity (Sub-study of NCT05774756)

Location Details

NCT06760546

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Albama

University of Alabama

Birmingham, Albama, United States, 35233

RECRUITING

United States, Massachusetts

Boston Children's Hospital

Boston, Massachusetts, United States, 02115

RECRUITING

United States, Minnesota

Children's Minnesota

Saint Paul, Minnesota, United States, 55102

RECRUITING

United States, New York

Columbia University Irving Medical Center

New York, New York, United States, 10032