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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 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.

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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

Conditions Studied

Obesity Weight Change, Body Weight Change Trajectory

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

FieldValue
Enrollment Target 315 participants
Start Date 2024-09-01
Est. Completion 2027-02-26
Phase NA

Sponsor

Fractyl Health

2 total trials

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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, categorized as NA. The registered enrollment target is 315 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (62% lower). The listed sponsor is Fractyl Health, which has 2 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 4 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.