Study S000777

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

ClinicalTrials.gov record

Registration

Registration: NCT06484114
Acronym: REMAIN-1
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Masking: TRIPLE
Status: ACTIVE_NOT_RECRUITING
Enrollment: 315
Start: 2024-09-01
Primary completion: 2027-02-15
Lead sponsor: Fractyl Health Inc.
Conditions: Obesity; Weight Change Trajectory; Weight Change, Body
Interventions: DEVICE:Revita Duodenal Mucosal Resurfacing (DMR); DEVICE:Sham
Results posted: FALSE
Individual participant data sharing: NO

Registered primary outcomes

To demonstrate that Revita DMR is superior to sham in percent change in body weight from baseline to week 26 [26 Weeks]
To demonstrate that a majority of Revita DMR participants maintain clinically significant weight loss 52 weeks (1 year) after discontinuing tirzepatide therapy [52 weeks]

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