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ACTIVE NOT RECRUITING Phase 3

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

NCT05093634 · View on ClinicalTrials.gov ↗

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

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

33 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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 296 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rhythm Pharmaceuticals, which has 33 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05093634 reports 20 study locations spanning 13 distinct geographic areas — top geographies include New York, Arizona, Michigan. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05093634?

The interventions under investigation include: Placebo (DRUG), Setmelanotide (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05093634?

This trial is sponsored by Rhythm Pharmaceuticals, which has 33 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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