RECRUITING

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

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.

Conditions

Hypothalamic ObesityMultiple Pituitary Hormone Deficiency Genetic FormSepto-Optic DysplasiaOptic Nerve HypoplasiaChildhood-onset Combined Pituitary Hormone DeficiencyPituitary Stalk Interruption Syndrome
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Related Conditions:

Hypothalamic ObesityMultiple Pituitary Hormone Deficiency Genetic FormSepto-Optic DysplasiaOptic Nerve HypoplasiaChildhood-onset Combined Pituitary Hormone DeficiencyPituitary Stalk Interruption Syndrome

Study Overview

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Study Details

Study overview

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.

A Phase 3, Double Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Setmelanotide in Patients With Acquired Hypothalamic Obesity

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

Condition
Hypothalamic Obesity
Intervention / Treatment

-

Contacts and Locations

Birmingham

University of Alabama, Birmingham, Alabama, United States, 35233

Boston

Boston Children's Hospital, Boston, Massachusetts, United States, 02115

Saint Paul

Children's Minnesota, Saint Paul, Minnesota, United States, 55102

New York

Columbia University Irving Medical Center, New York, New York, United States, 10032

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

4 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Rhythm Pharmaceuticals, Inc.,

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

Study Record Dates

2027-01-30