Fractyl Reports Six-Month Weight-Maintenance Trial Success for Revita
The company said Revita users regained less weight than sham-treatment participants after stopping GLP-1 therapy in the REMAIN-1 study.
Key takeaways
- Revita participants regained 5.1% of body weight, versus 8.2% for sham participants, at six months.
- Fractyl plans to submit a De Novo application in late Q4 2026 and expects one-year results in Q1 2027.
Fractyl Health said its Revita procedure met a six-month co-primary endpoint in the REMAIN-1 study, with less weight regain than a sham procedure after participants stopped GLP-1 therapy. The company reported average regain of 5.1% of body weight for Revita participants, compared with 8.2% for sham.
The company said Revita participants retained about 80% of their GLP-1-induced weight loss, versus 67% in the sham group. The difference met the study’s statistical threshold, with a reported p-value of 0.0023. REMAIN-1 is a randomized, double-blind study involving 308 adults with obesity.
A post hoc analysis found 32% of Revita participants were weight-stable or lost more weight six months after stopping GLP-1 therapy, compared with 18% in the sham group. Fractyl also reported less regain among participants who received at least 20 centimeters of duodenal ablation, but labeled that analysis post hoc.
Revita remains investigational in the United States. Fractyl plans to submit a De Novo marketing application to the FDA in late Q4 2026 and expects one-year pivotal results, including the second co-primary endpoint, in Q1 2027. The company said a potential U.S. launch is planned for early 2028; the FDA will determine the final regulatory pathway after reviewing the complete safety data.
This article was produced with the help of AI technology. Based on reporting by the outlets listed above.
