RECRUITING

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

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Conditions

Hypothalamic ObesityMultiple Pituitary Hormone Deficiency Genetic FormSepto-Optic DysplasiaOptic Nerve HypoplasiaChildhood-onset Combined Pituitary Hormone DeficiencyPituitary Stalk Interruption Syndromemelancortin 4 receptor, MC4R

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2025-09-22
Study Completion:2027-01-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06760546

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:4 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 2. Age 4 years and older
  3. 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. 4. Agree to use a highly effective form of contraception throughout the study and for 90 days after the study
  1. 1. Diagnosis of Prader-Willi syndrome (PWS) or Rapid-onset obesity with hypoventilation, hypothalamic, autonomic dysregulation, neuroendocrine tumor syndrome (ROHHADNET)
  2. 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. 3. Bariatric surgery or procedure within last 2 years
  4. 4. Diagnosis of severe psychiatric disorders; any suicidal ideation, attempt or behavior
  5. 5. Current, clinically significant pulmonary, cardiac, metabolic, or oncologic disease
  6. 6. Significant dermatologic findings relating to melanoma or pre-melanoma skin lesions (excluding non-invasive basal or squamous cell lesion)
  7. 7. History or close family history of skin cancer or melanoma
  8. 8. Participation in any clinical trial with an investigational drug/device within 3 months prior to the first trial dose
  9. 9. Previously enrolled in a clinical trial involving setmelanotide or any previous exposure to setmelanotide
  10. 10. Inability to comply with once daily (QD) injection regimen
  11. 11. If female, pregnant and/or breastfeeding.
  12. 12. If receiving hormone replacement therapy, dose has remained stable for at least 2 months before Screening

Contacts and Locations

Study Contact

Rhythm Clinical Trials
CONTACT
(857) 264-4280
clinicaltrials@rhythmtx.com
Physician Inquiry Clinical Trials
CONTACT
(857) 264-4280
clinicaltrials@rhythmtx.com

Principal Investigator

David Meeker, MD
STUDY_CHAIR
Rhythm Pharmaceuticals, Inc.

Study Locations (Sites)

University of Alabama
Birmingham, Alabama, 35233
United States
Boston Children's Hospital
Boston, Massachusetts, 02115
United States
Children's Minnesota
Saint Paul, Minnesota, 55102
United States
Columbia University Irving Medical Center
New York, New York, 10032
United States

Collaborators and Investigators

Sponsor: Rhythm Pharmaceuticals, Inc.

  • David Meeker, MD, STUDY_CHAIR, Rhythm Pharmaceuticals, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-22
Study Completion Date2027-01-30

Study Record Updates

Study Start Date2025-09-22
Study Completion Date2027-01-30

Terms related to this study

Keywords Provided by Researchers

  • melancortin 4 receptor, MC4R

Additional Relevant MeSH Terms

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