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NCT05093634 · ClinicalTrials.gov registry record · Phase 3

EMANATE: A Study of Setmelanotide in Patients With Specific Gene Variants in the MC4R Pathway

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

Active
Registry status
Phase 3
Development phase
296
Enrollment target
20
Study locations

NCT05093634 is a Phase 3 study of Obesity and Genetic Obesity that is active but no longer recruiting, run by Rhythm Pharmaceuticals. The registered enrollment target is 296 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (64% lower). The trial reports 20 study locations across 13 states.

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The verdict

NCT05093634, a Phase 3 study of Obesity and Genetic Obesity, is active but no longer recruiting, sponsored by Rhythm Pharmaceuticals.

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

Study Summary

The protocol describes a randomized, double-blind, placebo-controlled trial with independent sub-studies of setmelanotide in patients with obesity and at least one of the specific gene variants in the Melanocortin-4 Receptor pathway: * POMC or PCSK1 (Sub-study 035a) * LEPR (Sub-study 035b) * SRC1 (Sub-study 035c) * SH2B1 (Sub-study 035d) The objectives and endpoints are identical for these sub-studies.

Conditions Studied

Obesity Genetic Obesity

Interventions

  • DRUG Placebo
  • DRUG Setmelanotide

Study Locations (20)

New York

  • University of Buffalo - Buffalo
  • Metropolitan Hospital Center - New York
  • Mount Sinai Hospital - New York
  • Columbia University - New York
  • Ten's Medical Center - Pediatric Endocrinology Clinic - Staten Island

Arizona

  • Phoenix Children's Hospital - Phoenix
  • HonorHealth Bariatric Center - Scottsdale

Michigan

  • University of Michigan - Ann Arbor
  • Metro Detroit Endocrinology Center - Dearborn

Missouri

  • St. Luke's Hospital - Chesterfield
  • Washington University in St. Louis - St Louis

California

  • Children's Hospital Los Angeles - Los Angeles

Colorado

  • Children's Hospital Colorado - Aurora

Connecticut

  • Yale Center for Clinical Investigation - New Haven

Florida

  • Advent Health - Altamonte Springs

Trial Details

FieldValue
Enrollment Target 296 participants
Start Date 2021-12-10
Est. Completion 2026-12-31
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 NCT05093634

The ClinicalTrials.gov registry entry for NCT05093634 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 296 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 (64% lower). The listed sponsor is Rhythm Pharmaceuticals, which has 23 total studies on file at ClinicalTrials.gov.

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

NCT05093634 reports 20 study locations spanning 13 distinct geographic areas - top geographies include New York, Arizona, Michigan.

Frequently Asked Questions

What is clinical trial NCT05093634 about?

NCT05093634 is a clinical study titled "EMANATE: A Study of Setmelanotide in Patients With Specific Gene Variants in the MC4R Pathway". The protocol describes a randomized, double-blind, placebo-controlled trial with independent sub-studies of setmelanotide in patients with obesity and at least one of the specific gene variants in the Melanocortin-4 Receptor pathway: * POMC or PCSK1 (Sub-study 035a) * LEPR (Sub-study 035b) * SRC1 (...

What is the current status of trial NCT05093634?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 296 participants. The study started on 2021-12-10. Estimated completion is 2026-12-31.

What conditions does trial NCT05093634 study?

This clinical trial studies the following conditions: Obesity, Genetic Obesity.

What interventions are being tested in trial NCT05093634?

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

Who is sponsoring clinical trial NCT05093634?

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

Where is trial NCT05093634 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Connecticut, 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.