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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: Active Phase 3 study of Obesity and Genetic Obesity, sponsored by Rhythm Pharmaceuticals.
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. According to ClinicalTrials.gov, the official US trial registry.
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
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
| Field | Value |
|---|---|
| Enrollment Target | 296 participants |
| Start Date | 2021-12-10 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 3 |
What the registry record for NCT05093634 still lists
NCT05093634 is an interventional study that assigns participants to a tested intervention. The registered 296 participants enrollment target is mid-sized for trials with a published cap, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (64% lower).
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 names 20 study sites across 13 states, led by 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.
Learn More About Clinical Trials
Similar trials for Obesity
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05093634's enrollment target sits among peer trials
296 230th of 1053 higher than 824 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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