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NCT06484114 · ClinicalTrials.gov registry record · NA
Evaluation of the Safety and Efficacy of Revita® DMR on Body Weight Maintenance in Subjects With Obesity Who Have Achieved at Least 15% Weight Loss on Tirzepatide
A NA study of Obesity and Weight Change, Body, sponsored by Fractyl Health.
- Active
- Registry status
- NA
- Development phase
- 315
- Enrollment target
- 20
- Study locations
NCT06484114: Active NA study of Obesity and Weight Change, Body, sponsored by Fractyl Health.
NCT06484114 is a NA study of Obesity and Weight Change, Body that is active but no longer recruiting, run by Fractyl Health. The registered enrollment target is 315 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (62% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06484114, a NA study of Obesity and Weight Change, Body, is active but no longer recruiting, sponsored by Fractyl Health.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 315 participants
- Enrollment target
- 20
- Study locations
Study Summary
Fractyl is evaluating Revita Duodenal Mucosal Resurfacing (DMR) in the REMAIN-1 pivotal study, which is designed to include two cohorts - an open label cohort referred to as REVEAL-1, and a randomized cohort, which includes both a midpoint analysis and a pivotal analysis. Patients who previously lost at least 15% of their body weight on a GLP-1 can qualify for the open label REVEAL-1 cohort. The data generated from the REVEAL-1 cohort will be used for open label reporting as the study progresses. The REMAIN-1 randomized cohort will enroll patients living with obesity and a body mass index ("BMI") between 30 and 45 kg/m2 who are not currently on a GLP-1 drug. Patients will be prescribed tirzepatide and titrated to achieve at least 15% total body weight loss, at which time tirzepatide will be discontinued and patients will be randomized to Revita versus sham at 2:1. Midpoint Analysis of Randomized Cohort: The midpoint analysis of the randomized cohort will be performed at three months of follow-up on approximately 45 patients, allowing us to assess and report on safety and efficacy signals that could be anticipated in the pivotal analysis. These patients are distinct from those included in the pivotal analysis. Pivotal Analysis of Randomized Cohort: The pivotal analysis of the randomized cohort will be performed on approximately 315 patients (distinct from those included in the midpoint analysis) and will evaluate safety and efficacy in the first co-primary endpoint, which is weight regain from the time of tirzepatide discontinuation in Revita DMR versus sham patients at six months, with a primary objective of demonstrating a benefit of Revita DMR versus sham for weight maintenance after GLP-1 discontinuation. The second co-primary endpoint evaluates a responder rate among the Revita DMR treated group at one year to demonstrate the durability of the Revita DMR procedure for weight maintenance after discontinuation of a GLP-1-based therapy. Secondary objectives wi
Primary Outcome
Percent change in total body weight from baseline to week 26, DMR vs sham
Conditions Studied
Interventions
- DEVICE Sham
- DEVICE Revita Duodenal Mucosal Resurfacing (DMR)
Study Locations (20)
Florida
- Zenith Clinical Research - Hollywood
- Nature Coast Clinical Research - Inverness
- Jacksonville Center for Clinical Research - Jacksonville
- Encore Borland-Groover Clinical Research - Jacksonville
- International Research Associates - Miami
- Advent Health - Orlando
- K2 Medical Research South Orlando - Orlando
- Orlando Health Weight Loss and Bariatric Surgery Institute - Orlando
- Synexus Clinical Research Institute - The Villages (AES) - The Villages
- Metabolic Research Institute - West Palm Beach
- Cleveland Clinic, Weston - Weston
Indiana
- Investigators Research Group, LLC - Brownsburg
- American Health Network - Franklin - Franklin
- American Health Network - Greenfield - Greenfield
- Indiana University - Indianapolis
- American Health Network - Muncie - Muncie
Arizona
- Helios Clinical Research - Phoenix
- Honor Health - Scottsdale
California
- Hoag Hospital - Newport Beach
- UCLA Santa Monica Medical Center - Santa Monica
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 315 participants |
| Start Date | 2024-09-01 |
| Est. Completion | 2027-02-26 |
| Phase | NA |
What the registry record for NCT06484114 still lists
NCT06484114 is an interventional study that assigns participants to a tested intervention. The registered 315 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 (62% lower).
The record links to 3 conditions, with Obesity appearing as the primary indexed condition, and to 2 interventions - of which Sham is the first listed.
NCT06484114 names 20 study sites across 4 states, led by Florida, Indiana, Arizona.
Frequently Asked Questions
What is clinical trial NCT06484114 about?
NCT06484114 is a clinical study titled "Evaluation of the Safety and Efficacy of Revita® DMR on Body Weight Maintenance in Subjects With Obesity Who Have Achieved at Least 15% Weight Loss on Tirzepatide". Fractyl is evaluating Revita Duodenal Mucosal Resurfacing (DMR) in the REMAIN-1 pivotal study, which is designed to include two cohorts - an open label cohort referred to as REVEAL-1, and a randomized cohort, which includes both a midpoint analysis and a pivotal analysis. Patients who previously los...
What is the current status of trial NCT06484114?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 315 participants. The study started on 2024-09-01. Estimated completion is 2027-02-26.
What conditions does trial NCT06484114 study?
This clinical trial studies the following conditions: Obesity, Weight Change, Body, Weight Change Trajectory.
What interventions are being tested in trial NCT06484114?
The interventions under investigation include: Sham (DEVICE), Revita Duodenal Mucosal Resurfacing (DMR) (DEVICE).
Who is sponsoring clinical trial NCT06484114?
This trial is sponsored by Fractyl Health, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06484114 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT06484114's enrollment target sits among peer trials
315 208th of 1053 higher than 846 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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