Fractyl Health (GUTS) Study result summary

Study design and methodology

• REMAIN-1 is a randomized, double-blind, sham-controlled proof-of-concept study in adults with obesity (BMI 30–45) who are GLP-1 naive, non-diabetic, and achieved ≥15% weight loss on tirzepatide before randomization 2:1 to Revita or sham.

• The study assessed four analysis populations, including full mITT, high run-in, complete ablation (>14 cm), and optimized responders (high run-in + complete ablation).

• Dietary and lifestyle interventions mirrored those in GLP-1 studies, with centralized blinded dieticians overseeing adherence.

• High retention was observed, with 91% of participants completing 12 months and no post-randomization GLP-1 or anti-obesity medication reinitiation.

• The pivotal REMAIN-1 Cohort is fully randomized (n=315), with topline six-month data expected early Q4 2026 and potential FDA De Novo submission late Q4 2026.

Key efficacy results

• Revita patients maintained up to 84% of GLP-1-induced weight loss at one year, compared to 46% in the sham arm in the optimized and complete ablation cohorts.

• In the complete ablation group, Revita patients regained 4.8% of baseline weight versus 13.0% in sham, retaining 81% of weight loss versus 48% in sham.

• In the full mITT population, Revita reduced weight regain by about 40% compared to sham (7.8% vs 13.0% regain).

• The weight-maintenance responder rate was 73% in the mITT population and 91% in the complete ablation group.

• High GLP-1 responders (≥17.5% run-in loss) retained 74% of weight loss with Revita versus 46% in sham.

Dose-response and analysis populations

• Greater ablation length correlated with improved weight maintenance; >14 cm defined as complete ablation for per-protocol analysis.

• Dose-response findings informed pivotal study design, with >14 cm ablation adopted as threshold for effect.

• Optimized responder population identified as those with both high run-in loss and complete ablation.

• Dose optimization (longer ablation length) and patient selection (higher initial weight loss) enhance efficacy.

• All physicians achieved complete ablations in pivotal, supporting commercial training.