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)
A Prospective, Randomized, Double-Blind, Sham-Controlled, Multicenter, Pivotal Study to Assess the Efficacy of Revita® Duodenal Mucosal Resurfacing (DMR) on Body Weight Maintenance in Participants With Obesity and Who Have Achieved at Least 15% Weight Loss on Tirzepatide Obesity Pharmacotherapy
🩺 Plain-English Summary (8th-Grade Level)
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 will include evaluation of the effectiveness of the Revita DMR procedure on the change in blood glucose levels, cardiovascular disease ("CVD") risk factors, body composition and pre-diabetes status. All patients enrolled in the study will receive diet and lifestyle counseling.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (12 items) and avoid the listed exclusions (49 items).
Location: Helios Clinical Research — Phoenix, Arizona
Age range: 21 Years to 70 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Medical conditions that contraindicate the use of tirzepatide for weight management, as detailed in the tirzepatide prescribing information
- BMI ≥ 40 kg/m2 at Visit 7
- Females who are or intend to be pregnant or breastfeeding during the study
- Known serious hypersensitivity to tirzepatide or any of the excipients in tirzepatide
- History of infectious liver disease excluding recovered Hepatitis A infection
- History of pancreatitis within 6 months of screening or any prior history of recurrent pancreatitis (i.e., two or more episodes of pancreatitis)
- Potentially unreliable participants or those judged by the investigator to be unsuitable for the study
- Unable or unwilling to follow the dietary restrictions specified by the clinical protocol
- Known history of or active binge eating disorder or suspected binge eating disorder based on binge eating disorder assessment questionnaire
- Known history of or active substance abuse including alcohol within the past 2 years that, in the opinion of the investigator, may preclude the participant from following the protocol and completing the study
- Have history of use of marijuana or tetrahydrocannabinol (THC)-containing products within 3 months of screening or unwillingness to abstain from marijuana or THC-containing products use during the study Diabetes-related conditions:
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (32 Sites)
Showing the first 25 of 32 sites.
- Helios Clinical Research — Phoenix, Arizona
- Honor Health — Scottsdale, Arizona
- Hoag Hospital — Newport Beach, California
- UCLA Santa Monica Medical Center — Santa Monica, California
- Zenith Clinical Research — Hollywood, Florida
- Nature Coast Clinical Research — Inverness, Florida
- Jacksonville Center for Clinical Research — Jacksonville, Florida
- Encore Borland-Groover Clinical Research — Jacksonville, Florida
- International Research Associates — Miami, Florida
- Advent Health — Orlando, Florida
- K2 Medical Research South Orlando — Orlando, Florida
- Orlando Health Weight Loss and Bariatric Surgery Institute — Orlando, Florida
- Synexus Clinical Research Institute - The Villages (AES) — The Villages, Florida
- Metabolic Research Institute — West Palm Beach, Florida
- Cleveland Clinic, Weston — Weston, Florida
- Investigators Research Group, LLC — Brownsburg, Indiana
- American Health Network - Franklin — Franklin, Indiana
- American Health Network - Greenfield — Greenfield, Indiana
- Indiana University — Indianapolis, Indiana
- American Health Network - Muncie — Muncie, Indiana
- University of Michigan — Ann Arbor, Michigan
- Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire
- NYC Research, Inc. (Endocrine Associates of West Village) — Long Island City, New York
- NYU-Langone — New York, New York
- Preferred Primary Care Physician Pittsburgh — Pittsburgh, Pennsylvania
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
- 💵 Compensation indicated: Eligible participants will receive an open-label, tirzepatide run-in, dose-escalation period of approximately 16-26 weeks duration.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.