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Investor Relations14 Oct 2025
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Fractyl Health (GUTS) investor relations material
Fractyl Health Study Update summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Study Update summary26 Sep, 2025
Study background and rationale
Revita is an endoscopic duodenal ablation procedure designed to provide durable weight maintenance after GLP-1 discontinuation, aiming to reset metabolic function without chronic therapy and targeting a high unmet need in obesity care.
Revita holds FDA Breakthrough Device designation for weight maintenance in patients discontinuing GLP-1 therapy.
The REMAIN-1 program is modeled after established GLP-1 discontinuation studies, focusing on post-GLP-1 weight maintenance.
Study design and objectives
REMAIN-1 is a prospective, randomized, double-blind, sham-controlled study evaluating Revita for weight maintenance after GLP-1 discontinuation in adults with obesity without type 2 diabetes.
45 adults with obesity (BMI 30-45 kg/m²), GLP-1 naïve, and no T2D, who achieved ≥15% weight loss on tirzepatide, were randomized 2:1 to Revita or sham after stopping GLP-1 therapy.
Baseline characteristics were balanced, with both groups achieving 18% weight loss on tirzepatide and 100% retention through 3 months.
The primary endpoint was total body weight change at 3 months post-procedure, with additional endpoints at 6 and 12 months.
Additional assessments included DEXA scans, metabolic markers, and patient-reported outcomes.
Key results and efficacy
At 3 months post-GLP-1 discontinuation, Revita patients lost an additional 2.5% total body weight, while sham patients regained 10%, resulting in a 12.5% treatment difference (p=0.014; 95% CI, -18.4 to -2.1%).
Revita patients maintained or further reduced weight, while sham patients showed immediate, steady weight regain.
The effect size was statistically significant and clinically meaningful, exceeding expectations based on prior studies.
Early weight maintenance signals at 1-3 months have historically predicted durable effects at longer time points.
The study provides the first randomized, double-blind evidence that weight maintenance is possible without chronic drug therapy.
Revita 3-month weight maintenance benefit
Any serious adverse events for Revita at 3 months?
What new therapeutic category does Revita target?
Commercial strategy for GLP-1 off-ramp demand?
Evidence for Revita's long-term durability?
Revita's role as a backbone therapy in obesity?
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Next Fractyl Health earnings date
Q3 202511 Nov, 2025
Next Fractyl Health earnings date
Q3 202511 Nov, 2025
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Frequently asked questions
Fractyl Health Inc. is a healthcare biotechnology company dedicated to the development of innovative therapies for metabolic diseases, particularly type 2 diabetes (T2D) and obesity. The company's main therapeutic platforms include Revita DMR and Rejuva. Revita DMR is an outpatient procedural therapy aimed at modifying duodenal dysfunction—a condition influenced by a high-fat and high-sugar diet which can lead to T2D and obesity. Rejuva represents a novel gene therapy platform, delivered via adeno-associated virus, designed to achieve long-term remission of T2D and obesity by altering metabolic hormone function in pancreatic islet cells. The company is headquartered in Burlington, Massachusetts, and its shares are listed on the NASDAQ.
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