The US FDA Grants IDE Approval to Fractyl Health for Initiating Remain-1 Trial of Revita to Treat Obesity
Shots:
- The Remain-1 study, anticipated in H2’24, evaluates Revita vs sham in obese individuals (n=315) with BMI ≥30 kg/m^2 to receive tirzepatide for attaining a weight loss of at least 15% followed by its discontinuation. An open-label cohort, Reveal-1, with same patient population & management protocol, is planned parallel to the study, with ongoing data updates
- The study aims to find the percentage change in body weight from baseline to wk.24 and to show that individuals sustain weight loss post tirzepatide discontinuation
- Revita is an outpatient endoscopic procedure that utilizes hydrothermal ablation to remodel the duodenal lining enabling the editing of abnormal intestinal nutrient sensing & signaling mechanisms to address metabolic diseases
Ref: Fractyl Health| Image: Fractyl Health
Related News:- The US FDA Grants Approval for Initiating the Study of USGI Medical’s POSE2.0 Incisionless Weight Loss Procedure for Primary Obesity
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