Announcement • Aug 04
Fractyl Health, Inc. to Report Q2, 2026 Results on Aug 10, 2026 Fractyl Health, Inc. announced that they will report Q2, 2026 results on Aug 10, 2026 Announcement • Jul 15
Fractyl Health Reports One-Year Results from Remain-1 Midpoint Cohort Demonstrating Durable Weight Maintenance After Glp-1 Discontinuation Fractyl Health, Inc. reported one-year data from its REMAIN-1 Midpoint Cohort, a blinded, sham-controlled study evaluating Revita for weight maintenance following GLP-1 drug discontinuation. Dose-dependent durability confirmed at one year: In the full modified intention-to-treat (mITT) population (N=45), a single Revita procedure reduced weight regain by approximately 40% versus sham at one year (least-squares mean weight regain of 7.8% versus 13.0% of body weight; n=29 versus 16 for Revita versus sham). Participants who received complete duodenal ablation (>14 cm) maintained approximately 81% of GLP-1-induced weight loss at one year, compared with 48% in sham participants (least-squares mean weight regain of 4.8% versus 13.0% of body weight; n=17 versus 16 for Revita versus sham), reflecting a reduction in weight regain of over 60% versus sham. In an optimized population of participants who received complete duodenal ablation (>14 cm) and had higher GLP-1 run-in weight loss (17.5%), Revita maintained approximately 84% of GLP-1-induced weight loss at one year versus 46% with sham (least-squares mean weight regain of 4.1% versus 13.5% of body weight; n=10 versus 8 for Revita versus sham). The second co-primary endpoint of the Pivotal Cohort, assessed against a U.S. Food and Drug Administration (FDA) mandated pre-specified performance goal of >50%, measures the proportion of Revita patients maintaining at least 5% total body weight loss relative to their pre-tirzepatide weight at one year. As a reference point for the Pivotal Cohort, this responder rate was 73% in the Midpoint Cohort mITT population, rising to 91% in those with complete duodenal ablation (>14 cm). No device- or procedure-related serious adverse events occurred. No new device-related treatment-emergent adverse events (TEAEs) were observed between six and 12 months. Overall TEAE rates were comparable between arms through one year (24% Revita versus 25% sham), reflecting a generally mild peri-procedural adverse event profile that supports potentially broad outpatient use for Revita. One new diagnosis of type 2 diabetes occurred in the sham arm versus none with Revita. The new results reinforce the potential of the Revita DMR System (Revita) to be the first durable procedural therapy for post-GLP-1 weight maintenance. The success of GLP-1 medicines has created a new unsolved problem: what happens when patients stop. 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. REMAIN-1 is Fractyl Healths pivotal program evaluating Revita for weight maintenance in adults with obesity following discontinuation of GLP-1 therapy. The Midpoint Cohort (N=45) is a randomized, double-blind, sham-controlled study in adults who achieved at least 15% total body weight loss on tirzepatide; after discontinuing the drug, participants were randomized 2:1 to a single Revita procedure or a sham endoscopic procedure and followed for one year. The Midpoint Cohort is not powered for formal statistical significance; results are descriptive and are intended to characterize the treatment effect and inform the Pivotal Cohort design and execution. Results in the Midpoint Cohort at one year are evaluated per the pre-specified statistical analysis plan defined for the pivotal study, with GLP-1 weight loss fitted as a covariate on treatment effects, calculated as least-square means at the 20% reference. Both a Complete Ablation cohort (defined as >14cm of duodenal ablation) and an Optimized responder population (with > 14 cm duodenal ablation and 17.5% run-in weight loss) are pre-specified key secondary endpoints in the pivotal study. The Pivotal Cohort is fully randomized and well powered at the expected effect size to clear both co-primary endpoints in the modified intention-to-treat (mITT) population: (i) weight regain at six months (Revita versus sham) and (ii) a responder rate defined as the proportion of participants maintaining at least 5% total body weight loss relative to their pre-tirzepatide weight at one year. Topline six-month randomized data from the Pivotal Cohort are anticipated in early Fourth Quarter 2026. Revita is Fractyl Healths lead product candidate, designed to remodel the duodenal lining via a one-time, minimally invasive endoscopic procedure intended to restore healthy nutrient sensing and signaling disrupted by chronic metabolic disease. Revita has received Breakthrough Device designation from the FDA for weight maintenance in people with obesity who discontinue GLP-1 therapies. Revita is for investigational use only in the United States and is CE marked in the European Union and United Kingdom. REMAIN-1 Midpoint Cohort weight maintenance pilot Designed to inform design and execution of REMAIN-1 Pivotal Cohort Patient population Adults with obesity (BMI 30-45 kg/m2) GLP-1 na ve; no T2D n45 Efficacy endpoints % TBW change Revita vs sham at 3 and 6 months Study design Randomized (2:1 Revita vs Sham), double-blind, sham-controlled TZP administration to achieve 15% TBWL, then discontinued Diet and lifestyle counseling throughout Key milestones Midpoint cohort 3-mo data: September 25 Midpoint cohort 6-mo data: January 26 Midpoint cohort 12-mo data: July '26 Tirzepatide initiation and titration to achieve 15% TBWL Revita treatment (n30) Weight at 3, 6, & 12 months (n30) Sham procedure (n15) Weight at 3, 6, & 12 months (n 15) Study design Discontinue TZP 2:1 R REMAIN-1 Midpoint Cohort. N=46 randomized; 1 screen-failure excluded (not treated); N=45 modified intention-to-treat (mITT). REMAIN-1 Midpoint Cohort patient disposition High retention through one year of follow-up 41 of 45 treated participants (91%) remained on study through Week 52 (12 months) Only 4 discontinued (1 Revita, 3 sham): all withdrew consent No post-randomization GLP-1 reinitiation through 52 weeks Safety and efficacy analyses use all available data (n=45) Treatment policy estimand and efficacy estimand are identical. 
