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NCT06772597 · ClinicalTrials.gov registry record · Phase 2

A Study of Setmelanotide in Patients With Prader-Willi Syndrome

A Phase 2 study of Obesity and Prader-Willi Syndrome, sponsored by Rhythm Pharmaceuticals.

Active
Registry status
Phase 2
Development phase
18
Enrollment target
1
Study location

NCT06772597 is a Phase 2 study of Obesity and Prader-Willi Syndrome that is active but no longer recruiting, run by Rhythm Pharmaceuticals. The registered enrollment target is 18 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06772597, a Phase 2 study of Obesity and Prader-Willi Syndrome, is active but no longer recruiting, sponsored by Rhythm Pharmaceuticals.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
18 participants
Enrollment target
1
Study location

Study Summary

This is a Phase 2, open-label study designed to assess the safety and efficacy of setmelanotide in patients with obesity due to Prader-Willi Syndrome (PWS) who are 6 to 65 years of age. Up to 20 patients are planned to be enrolled. Patients will take a daily subcutaneous dose of open-label setmelanotide for up to 52 weeks.

Conditions Studied

Obesity Prader-Willi Syndrome Hyperphagia

Interventions

  • DRUG Setmelanotide

Study Locations (1)

Florida

  • University of Florida - Gainesville

Trial Details

FieldValue
Enrollment Target 18 participants
Start Date 2025-03-04
Est. Completion 2027-10-31
Phase Phase 2

Sponsor

Rhythm Pharmaceuticals

23 total trials

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What the Registry Record Tells You About NCT06772597

The ClinicalTrials.gov registry entry for NCT06772597 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (98% lower). The listed sponsor is Rhythm Pharmaceuticals, which has 23 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with Obesity appearing as the primary indexed condition, and to 1 intervention - of which Setmelanotide is the first listed.

NCT06772597 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.

Frequently Asked Questions

What is clinical trial NCT06772597 about?

NCT06772597 is a clinical study titled "A Study of Setmelanotide in Patients With Prader-Willi Syndrome". This is a Phase 2, open-label study designed to assess the safety and efficacy of setmelanotide in patients with obesity due to Prader-Willi Syndrome (PWS) who are 6 to 65 years of age. Up to 20 patients are planned to be enrolled. Patients will take a daily subcutaneous dose of open-label setmelano...

What is the current status of trial NCT06772597?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2025-03-04. Estimated completion is 2027-10-31.

What conditions does trial NCT06772597 study?

This clinical trial studies the following conditions: Obesity, Prader-Willi Syndrome, Hyperphagia.

What interventions are being tested in trial NCT06772597?

The interventions under investigation include: Setmelanotide (DRUG).

Who is sponsoring clinical trial NCT06772597?

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

Where is trial NCT06772597 being conducted?

This trial has 1 study location across Florida. 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.