Fractyl Health is focusing on weight maintenance after GLP-1 withdrawal due to high demand from patients and doctors. The REMAIN-1 pivotal study is set to analyze data in Q2 2025, with full enrollment expected by summer 2025.
The company’s first gene therapy candidate, RJVA-001, has completed essential preclinical studies and plans to start human trials in early 2025.
This streamlined approach will help extend financial resources into 2026.
BURLINGTON, Mass., Jan. 31, 2025 (GLOBE NEWSWIRE) — Fractyl Health, Inc. is making important changes to focus on the REMAIN-1 study. This study answers the call for effective solutions to maintain weight after stopping GLP-1 medications. We’ve also received great responses from the REVEAL-1 cohort, showing strong interest from both patients and physicians for participation in REMAIN-1. To allocate resources better, we will pause our other Revita programs related to type 2 diabetes (T2D).
“Maintaining weight is the real challenge for many. The feedback we’ve received underscores the need for lasting solutions,” said Harith Rajagopalan, Co-Founder and CEO of Fractyl Health. “Revita is unique as it holds Breakthrough Device designation for weight maintenance. This focus aligns with our goal of effective treatments for obesity and metabolic diseases.”
Revita Study Update
- Recently, Fractyl shared positive early results from the REVEAL-1 group in the REMAIN-1 study. These findings show success in weight maintenance after stopping GLP-1 treatments. Further data will be shared in Q1 2025.
- In the REMAIN-1 study, over 145 patients have enrolled within five months, highlighting a strong need for post-GLP-1 weight maintenance solutions. The first analysis is scheduled for Q2 2025, with full enrollment expected by summer 2025.
Rejuva Gene Therapy Update
- Fractyl has made significant progress with RJVA-001, completing key preclinical studies to support trials in humans, expected to start in the first half of 2025.
Company Updates
- To better manage resources, Fractyl is reducing its workforce by 17%, which is anticipated to help the company financially into 2026.
About Fractyl Health
Fractyl Health is dedicated to innovative treatments for metabolic diseases like obesity and type 2 diabetes. The company aims to move beyond just managing symptoms and provide lasting solutions that address the root causes of these conditions. Based in Burlington, MA, Fractyl Health is at the forefront of creating effective therapies to truly transform disease management.
About Revita
Revita is Fractyl’s lead product, aimed at reshaping the gut to improve nutrient sensing that chronic high-fat and sugar diets disrupt. It has received Breakthrough Device designation in the U.S. for weight maintenance after discontinuing GLP-1 medications and is currently in the REMAIN-1 study.
About Rejuva
Rejuva focuses on advanced gene therapies for obesity and T2D. The aim is to alter the underlying issues related to these diseases. RJVA-001 is set to enter human trials soon, marking a significant milestone in this innovative space.
Forward-Looking Statements
This announcement includes future projections which may differ due to various factors, including regulatory processes and clinical developments. The company’s management estimates may change as the situation evolves.
Contact Information
Media Contact: Jessica Cotrone, jcotrone@fractyl.com, 978-760-5622
Investor Contact: Brian Luque, IR@fractyl.com, 951-206-1200
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