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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
NCT06484114 · View on ClinicalTrials.gov ↗
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06484114
The ClinicalTrials.gov registry entry for NCT06484114 describes a study currently listed as active not recruiting. It is categorized as NA, 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 315 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Fractyl Health, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. 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: NCT06484114 reports 20 study locations spanning 4 distinct geographic areas — top geographies include Florida, Indiana, Arizona. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06484114?
The interventions under investigation include: Sham (DEVICE), Revita Duodenal Mucosal Resurfacing (DMR) (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06484114?
This trial is sponsored by Fractyl Health, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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