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NCT06760546 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Hypothalamic Obesity and Septo-Optic Dysplasia, sponsored by Rhythm Pharmaceuticals.

Recruiting
Registry status
Phase 3
Development phase
39
Enrollment target
11
Study locations

NCT06760546: Recruiting Phase 3 study of Hypothalamic Obesity and Septo-Optic Dysplasia, sponsored by Rhythm Pharmaceuticals.

NCT06760546 is a Phase 3 study of Hypothalamic Obesity and Septo-Optic Dysplasia that is actively recruiting participants, run by Rhythm Pharmaceuticals. The registered enrollment target is 39 participants, below the 70-participant average among 5 other Hypothalamic Obesity trials with a reported enrollment target (44% lower). The trial reports 11 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06760546, a Phase 3 study of Hypothalamic Obesity and Septo-Optic Dysplasia, is actively recruiting participants, sponsored by Rhythm Pharmaceuticals.

RECRUITING
Registry status
Phase 3
Development phase
39 participants
Enrollment target
11
Study locations

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 Studied

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

Interventions

  • DRUG Placebo
  • DRUG Setmelanotide

Study Locations (11)

Alabama

  • University of Alabama - Birmingham

Colorado

  • Children's Hospital Colorado - Aurora

Illinois

  • Lurie Children's Hospital - Chicago

Massachusetts

  • Boston Children's Hospital - Boston

Minnesota

  • Children's Minnesota - Saint Paul

New York

  • Columbia University Irving Medical Center - New York

Pennsylvania

  • Children's Hospital of Philadelphia - Philadelphia

Washington

  • Seattle Children's Research Institute - Seattle

Trial Details

FieldValue
Enrollment Target 39 participants
Start Date 2025-09-23
Est. Completion 2028-03-13
Phase Phase 3
Rhythm Pharmaceuticals

23 total trials

What NCT06760546 shows while recruiting

NCT06760546 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 70-participant average among 5 other Hypothalamic Obesity trials with a reported enrollment target (44% lower).

The record links to 6 conditions, with Hypothalamic Obesity appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT06760546 lists 11 locations in 11 states (Alabama, Colorado, Illinois).

Frequently Asked Questions

What is clinical trial NCT06760546 about?

NCT06760546 is a clinical study titled "A Trial of Setmelanotide in Patients With Congenital Hypothalamic Obesity (Sub-study of NCT05774756)". 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 wo...

What is the current status of trial NCT06760546?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 39 participants. The study started on 2025-09-23. Estimated completion is 2028-03-13.

What conditions does trial NCT06760546 study?

This clinical trial studies the following conditions: Hypothalamic Obesity, Septo-Optic Dysplasia, Multiple Pituitary Hormone Deficiency Genetic Form, Optic Nerve Hypoplasia, Childhood-onset Combined Pituitary Hormone Deficiency.

What interventions are being tested in trial NCT06760546?

The interventions under investigation include: Placebo (DRUG), Setmelanotide (DRUG).

Who is sponsoring clinical trial NCT06760546?

This trial is sponsored by Rhythm Pharmaceuticals, which has 23 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06760546 being conducted?

This trial has 11 study locations across Alabama, Colorado, Illinois, Massachusetts, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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More recruiting context for NCT06760546

Source: ClinicalTrials.gov NCT06760546, the US trial registry maintained by the National Library of Medicine. NCT06760546 (small enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.