Fractyl Health says experimental procedure helps maintain weight loss in study

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By Padmanabhan Ananthan and Sneha S K

(Reuters) -Fractyl Health said its experimental outpatient procedure helped preserve weight loss after stopping a GLP-1 drug in a study, sending its shares 15% higher in morning trading on Friday.

The company was testing the efficacy of its experimental endoscopic procedure called Revita, which modifies a part of the small intestine in patients who had stopped tirzepatide, the active ingredient in Eli Lilly’s blockbuster weight-loss drug.

The study showed that people who underwent the procedure lost an additional 2.5% weight three months after stopping the drug, while others in the trial who had a sham procedure gained back 10% of their weight, the company said.

“This is the first randomized, blinded study suggesting that weight maintenance can be possible without chronic drug therapy,” CEO Harith Rajagopalan said on a conference call.

“This is a game changer, because it challenges the core assumption that obesity care must orbit around lifelong medical therapy,” he added.

Revita helps reverse damage caused to a part of the small intestine called the duodenum due to chronic high-fat and high-sugar diets that are a root cause of metabolic disease, according to the company.

The procedure also demonstrated favorable safety and tolerability, Fractyl said.

The study was designed to evaluate Revita in 45 adults with obesity who achieved at least 15% total body weight loss with tirzepatide.

Canaccord Genuity analysts said the results exceeded expectations.

Revita has a U.S. FDA Breakthrough Device designation in weight maintenance for people with obesity who discontinue GLP-1 drugs.

Fractyl Health said it planned to share six-month data from the study in the first quarter of 2026 and submit an application for approval in the second half 2026.

(Reporting by Sneha S K and Padmanabhan Ananthan in Bengaluru; Editing by Leroy Leo and Anil D’Silva)