REMAIN-1: Improved GLP-1-Induced Weight Loss Retention With Revita DMR System

New data from the REMAIN-1 Midpoint Cohort have indicated the potential of the Revita Duodenal Mucosal Resurfacing (DMR) System as the first durable procedural therapy for weight maintenance after GLP-1 RA discontinuation.1

Announced by parent company Fractyl Health on July 15, 2026, these 1-year results, despite being positive, are not intended to achieve formal statistical significance. Instead, the investigators indicate that results for this portion of the trial are intended to characterize the effects of the treatment to inform the design and execution of the later Pivotal Cohort, which will attempt to achieve statistical significance.1

“The success of GLP-1 medicines has created a new unsolved problem: what happens when patients stop,” Harith Rajagopalan, MD, PhD, co-founder and chief executive officer of Fractyl, said in a statement. “Most do stop eventually, whether because of cost, side effects, or simply not wanting to inject a drug for the rest of their lives. When they stop, the weight most often comes back. Today’s results are the first randomized, sham-controlled evidence that a single Revita procedure can keep most of the weight off for a full year after GLP-1 is stopped, without the need for ongoing medication.”1

Structure of the REMAIN-1 Trial

REMAIN-1 is an ongoing prospective, randomized, double-blind, sham-controlled, multicenter pivotal study assessing the Revita DMR System’s efficacy in maintaining body weight among patients with obesity who achieved ≥15% weight loss with GLP-1 RAs. The study is broken down into the present midpoint analysis and a pivotal analysis: the former assessed safety and efficacy signals, while the latter will examine the first co-primary endpoint of weight regain from tirzepatide discontinuation.2

Patients were eligible for inclusion in the trial if they were aged 21-70 years and had a body mass index (BMI) ≥30 kg/m2 and ≤45 kg/m2 prior to tirzepatide therapy. Additionally, patients were required to have ≥1 self-reported, unsuccessful dietary weight loss effort, as well as having achieved ≥15% weight loss on tirzepatide. Patients with a BMI ≥40 kg/m2 at visit 7 or a known hypersensitivity to tirzepatide, as well as a history of pancreatitis or infectious liver disease, were excluded.2

REMAIN-1 Outcomes and Results

After enrollment, the 45 patients in the midpoint cohort were randomly assigned in a 2:1 ratio to receive either a single Revita procedure or a sham endoscopic procedure, after which they were followed for 1 year. Although the investigators clearly explain that the midpoint cohort is not powered for statistical significance, the data indicate that a single Revita procedure successfully reduced weight by roughly 40% compared to sham by 1 year (least-squares mean weight regain of 7.8% vs 13% of body weight; n = 29 vs 16 for Revita vs sham). Additionally, patients who received complete duodenal ablation >14 cm maintained roughly 81% of GLP-1-induced weight loss at 1 year versus 48% in sham.1

Investigators also reported no serious adverse events related to either the device or procedure. No new device-related treatment-emergent adverse events (TEAEs) were observed between 6 and 12 months after treatment, and overall TEAE rates were comparable through 1 year, with 24% in the Revita arm and 25% in the sham arm. According to the team, this reflects a generally mild peri-procedural adverse event profile, supporting broad outpatient use for the device.1

“We eagerly anticipate an early Q4 2026 topline readout from the REMAIN-1 Pivotal Cohort with deep conviction that Revita may represent the first procedural entrant into the post-GLP-1 weight maintenance category,” Rajagopalan said in a statement.1

References

1. Fractyl Health. Fractyl Health Reports Positive Randomized Data from REMAIN-1 Midpoint Cohort Demonstrating Durable Weight Maintenance One Year After GLP-1 Discontinuation. July 15, 2026. Accessed July 15, 2026. https://www.globenewswire.com/news-release/2026/07/15/3327527/0/en/fractyl-health-reports-positive-randomized-data-from-remain-1-midpoint-cohort-demonstrating-durable-weight-maintenance-one-year-after-glp-1-discontinuation.html

2. Fractyl Health. 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 (REMAIN-1). ClinicalTrials.gov Identifier: NCT06484114. Updated March 3, 2026. Accessed July 15, 2026. https://clinicaltrials.gov/study/NCT06484114