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NCT05774756 · ClinicalTrials.gov registry record · Phase 3

A Trial of Setmelanotide in Acquired Hypothalamic Obesity

A Phase 3 study of Hypothalamic Obesity, sponsored by Rhythm Pharmaceuticals.

Active
Registry status
Phase 3
Development phase
120
Enrollment target
20
Study locations

NCT05774756 is a Phase 3 study of Hypothalamic Obesity that is active but no longer recruiting, run by Rhythm Pharmaceuticals. The registered enrollment target is 120 participants, above the 54-participant average among 5 other Hypothalamic Obesity trials with a reported enrollment target (122% higher). The trial reports 20 study locations across 16 states.

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The verdict

NCT05774756, a Phase 3 study of Hypothalamic Obesity, is active but no longer recruiting, sponsored by Rhythm Pharmaceuticals.

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
120 participants
Enrollment target
20
Study locations

Study Summary

The goal of this trial 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 acquired Hypothalamic Obesity (HO). To determine how well setmelanotide works and how safe it is, patients with HO will take a daily injection of either setmelanotide or placebo and complete trial assessments for 52 weeks on a therapeutic regimen. A separate sub-study in patients with congenital HO is detailed under NCT06760546.

Conditions Studied

Hypothalamic Obesity

Interventions

  • DRUG Placebo
  • DRUG Setmelanotide

Study Locations (20)

Other

  • Universitaetsklinikum Hamburg-Eppendorf (UKE) - Ambulanzzentrum des UKE GmbH - Hamburg
  • Medicover Neuroendokrinologie - München
  • University Children's Hospital, Klinikum Oldenburg - Oldenburg

Massachusetts

  • Boston Children's Hospital - Boston
  • Brigham and Women's Hospital - Boston

New York

  • Icahn School of Medicine at Mount Sinai - New York
  • Columbia University Irving Medical Center - New York

Alabama

  • UAN Pediatric Endocrinology - Birmingham

California

  • Rady Children's Hospital - San Diego

Colorado

  • Children's Hospital Colorado - Aurora

Florida

  • University of Florida - Gainesville

Illinois

  • Ann and Robert H. Lurie Children's Hospital - Chicago

Trial Details

FieldValue
Enrollment Target 120 participants
Start Date 2023-04-26
Est. Completion 2027-04-16
Phase Phase 3

Sponsor

Rhythm Pharmaceuticals

23 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05774756

The ClinicalTrials.gov registry entry for NCT05774756 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 54-participant average among 5 other Hypothalamic Obesity trials with a reported enrollment target (122% higher). The listed sponsor is Rhythm Pharmaceuticals, which has 23 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Hypothalamic Obesity appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT05774756 reports 20 study locations spanning 16 distinct geographic areas - top geographies include Other, Massachusetts, New York.

Frequently Asked Questions

What is clinical trial NCT05774756 about?

NCT05774756 is a clinical study titled "A Trial of Setmelanotide in Acquired Hypothalamic Obesity". The goal of this trial 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 acquired Hypothalamic Obesity (HO). To determine how well setmelanotide works and how safe it is, patients with HO will take a daily inje...

What is the current status of trial NCT05774756?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 120 participants. The study started on 2023-04-26. Estimated completion is 2027-04-16.

What conditions does trial NCT05774756 study?

This clinical trial studies the following conditions: Hypothalamic Obesity.

What interventions are being tested in trial NCT05774756?

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

Who is sponsoring clinical trial NCT05774756?

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

Where is trial NCT05774756 being conducted?

This trial has 20 study locations across Alabama, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.