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

NCT06760546 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2026-02-12

No results posted yet for this study

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.

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

Interventions

DRUG

Setmelanotide

Solution for daily subcutaneous injection

DRUG

Placebo

Placebo matched to setmelanotide for daily subcutaneous injection

Sponsors & Collaborators

  • Rhythm Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • David Meeker, MD · Rhythm Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-23
Primary Completion
2027-03-13
Completion
2028-03-13
FDA Drug
Yes

Countries

  • United States
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06760546 on ClinicalTrials.gov