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

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NCT06484114 · readout in 180 d

Sponsored by Fractyl Health Inc. (industry) · GUTS — their whole pipeline →.

Phase

Not applicable

Status

Active, not recruiting

Study type

Interventional

Design

Randomized · Triple · Prevention

Enrollment

315estimated

Sites

Country

United States

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

2024-09-01

actual

When the study began enrolling

Primary completion

2027-02-15

estimated

The date the last participant is measured for the primary outcome — the readout window

Study completion

2027-02-26

estimated

The whole study's end, after follow-up

First posted

2024-07-03

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-03-03

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Conditions

Obesity
Weight Change Trajectory
Weight Change, Body

Interventions

Device: Revita Duodenal Mucosal Resurfacing (DMR)
Device: Sham

Primary outcomes

what the primary-completion date above is the date OF

To demonstrate that Revita DMR is superior to sham in percent change in body weight from baseline to week 26

measured 26 Weeks

To demonstrate that a majority of Revita DMR participants maintain clinically significant weight loss 52 weeks (1 year) after discontinuing tirzepatide therapy

measured 52 weeks

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