Fractyl Health, a metabolic therapeutics company, has announced encouraging initial clinical results from the first patient in the REVEAL-1 open-label cohort of the REMAIN-1 study. The data indicates that the Revita procedure may help maintain weight loss after discontinuation of GLP-1 drugs. This development addresses a critical unmet need in obesity management, as many patients regain weight after stopping GLP-1 therapy.
The initial findings from the REVEAL-1 study showed that the first patient achieved a 15% total body weight loss with tirzepatide over seven months. Following the discontinuation of tirzepatide per the study protocol and subsequent Revita procedure, the patient maintained their weight loss one month post-procedure. This is in contrast to prior studies of tirzepatide withdrawal, which showed an average 3% weight regain within four weeks of GLP-1 discontinuation.
Revita's Potential for Long-Term Weight Management
The Revita procedure involves remodeling the duodenal lining via hydrothermal ablation, aiming to reverse damage to intestinal nutrient sensing and signaling mechanisms caused by chronic high-fat and high-sugar diets. Fractyl Health believes this approach targets the root causes of metabolic disease, offering a durable solution for weight management.
Dr. Shailendra Singh, Director of Bariatric Endoscopy at West Virginia University, noted, "In obesity, people who stop taking GLP-1 drugs are at high risk of rapid weight and metabolic rebound, jeopardizing the hard-won clinical benefits achieved with the drugs initially. For this reason, the unmet need in obesity has shifted from achieving weight loss to achieving sustained maintenance of a lower weight."
REMAIN-1 Study and Rejuva Program
Fractyl Health is also making significant progress in its REMAIN-1 pivotal study, which is evaluating weight maintenance after discontinuation of GLP-1 drugs. The study has seen high demand for participation, with over 100 patients enrolled across the first eight clinical study sites in less than four months since first site activation. A mid-point data analysis from the study is expected in Q2 2025.
In addition to Revita, Fractyl Health is advancing its Rejuva gene therapy platform, with plans to initiate first-in-human studies for RJVA-001 in the first half of 2025. RJVA-001 is a GLP-1 pancreatic gene therapy candidate designed for the treatment of type 2 diabetes.
Strategic Prioritization and Future Outlook
Fractyl Health is prioritizing the REMAIN-1 study and the Rejuva gene therapy platform, pausing investment in its Revita programs for type 2 diabetes. This strategic shift is expected to extend the company's cash runway into 2026.
Harith Rajagopalan, Co-Founder and CEO of Fractyl Health, stated, "The real challenge in obesity is no longer losing weight, it is keeping the weight off... By prioritizing REMAIN-1 and advancing our groundbreaking Rejuva gene therapy platform, we are channeling our resources toward what we believe are the most impactful and differentiated opportunities."
The company anticipates presenting additional data from the REVEAL-1 cohort in Q1 2025.
