FRACTYL HEALTH, INC. 8-K

What Happened

• Fractyl Health, Inc. (GUTS) announced 6‑month interim results from the REMAIN‑1 Midpoint Cohort on January 29, 2026 and held a conference call/webcast the same day. The blinded, sham‑controlled cohort evaluates the Revita DMR System (Revita) for maintaining weight loss after patients stop GLP‑1 drugs. The Midpoint Cohort is ongoing; 12‑month randomized data are expected in Q3 2026.

Key Details

• Prespecified efficacy population: n=40 (five participants excluded per protocol for diet/lifestyle noncompliance and counted only in safety). At 6 months, Revita patients had 4.5% weight regain vs 7.5% with sham (p=0.07, one‑sided).
• Exploratory subgroup (patients with above‑median GLP‑1 run‑in weight loss, n=20): Revita showed 4.2% regain vs 13.3% with sham — a ~70% relative reduction (LS mean difference −9.1%; p=0.004, one‑sided).
• Supportive exploratory signals: HDL cholesterol increased 15.5 vs 3.9 mg/dL (p=0.01, one‑sided); triglyceride/HDL ratio −0.2 vs +0.4 (p=0.03, one‑sided); reduced sweet‑food craving scores 1.8 vs 3.4 (p=0.04, one‑sided).
• Safety: favorable profile through 6 months — no device/procedure‑related serious adverse events, no discontinuations for adverse events, and no new related AEs between months 3 and 6.
• Regulatory progress & timeline: Fractyl requested FDA feedback on using the De Novo pathway (instead of PMA); feedback expected Q2 2026. Upcoming milestones include completing REMAIN‑1 pivotal cohort randomizations in Feb 2026, Q2 2026 1‑year REVEAL‑1 data, Q3 2026 1‑year REMAIN‑1 Midpoint randomized data, and H2 2026 pivotal cohort topline data and potential FDA filing.

Why It Matters

• These interim results suggest Revita may blunt expected weight regain after stopping GLP‑1 therapy, especially in patients who achieved larger initial weight loss on GLP‑1s—an area of growing clinical and commercial interest as many patients discontinue chronic GLP‑1 treatment. The safety profile to 6 months and the company’s request to pursue De Novo classification may influence the regulatory pathway and timing. Investors should note the Midpoint Cohort was not powered for definitive efficacy, p‑values reported are one‑sided, and more robust randomized data are expected later in 2026.