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Dilution score: 50/100 (MEDIUM), 11.0 months cash

13F fund flow: neutral, ? institutional managers

303 PubMed publications found for Fractyl Health, .

Abbreviated DAPT Regimens Across the Entire Spectrum of Bleeding Risk According to the PRECISE-HBR Score.

Elecoglipron, an oral small molecule GLP-1 receptor agonist in adults with obesity or overweight (VISTA): a multicentre, phase 2, randomised, placebo-controlled clinical trial.

Efficacy and safety of once-weekly cagrilintide-semaglutide (CagriSema) in adults with type 2 diabetes inadequately controlled on diet and exercise (REIMAGINE 1): a randomised, double-blind, placebo-controlled, phase 3a study.

Cagrilintide-semaglutide (CagriSema) versus semaglutide or cagrilintide in people with type 2 diabetes (REIMAGINE 2): a double-blind, randomised, controlled, phase 3 study.

Oral small molecule GLP-1 receptor agonist aleniglipron in people with overweight or obesity: a randomized, double-blind, placebo-controlled phase 2b trial.

Short interest: 1.7% of float, squeeze risk: LOW

SW convergence: 64/100 (Bullish Convergence), 2 bullish / 0 bearish signals

<article class="bts-verified-summary" data-ticker="GUTS">
<p>Fractyl Health, Inc. (GUTS) is the lead sponsor of 1 active clinical trials listed on ClinicalTrials.gov<sup><a href="#fn-1">[1]</a></sup>.</p>
<p>GUTS has 11 Form 4 insider filings recorded at the SEC in the past 30 days<sup><a href="#fn-2">[2]</a></sup>.</p>
<section class="sources" data-nosnippet aria-label="Sources"><h3>Sources</h3><ol><li id="fn-1">ClinicalTrials.gov (2026-06-17) <a href="https://clinicaltrials.gov/search?term=AREA%5BLeadSponsorName%5D+%22Fractyl+Health%2C+Inc.%22&amp;aggFilters=status%3Arec%2Cact" rel="nofollow noopener noreferrer">↗</a></li>
<li id="fn-2">SEC EDGAR · 0001572616 (2026-06-17) <a href="https://efts.sec.gov/LATEST/search-index?q=%22GUTS%22&amp;forms=4&amp;dateRange=custom&amp;startdt=2026-05-18&amp;enddt=2026-06-17" rel="nofollow noopener noreferrer">↗</a></li></ol></section>
</article>

ClinicalTrials.gov

SEC EDGAR — 0001572616

Fractyl Health, Inc. (GUTS) — BioTechSigns Verified Summary

Fractyl Health, Inc. (GUTS) is the lead sponsor of 1 active clinical trials listed on ClinicalTrials.gov[1].

GUTS has 11 Form 4 insider filings recorded at the SEC in the past 30 days[2].

Sources:
[1] ClinicalTrials.gov. Source last updated 2026-06-17, retrieved 2026-06-17.
    https://clinicaltrials.gov/search?term=AREA%5BLeadSponsorName%5D+%22Fractyl+Health%2C+Inc.%22&aggFilters=status%3Arec%2Cact
[2] SEC EDGAR, 0001572616. Source last updated 2026-06-17, retrieved 2026-06-17.
    https://efts.sec.gov/LATEST/search-index?q=%22GUTS%22&forms=4&dateRange=custom&startdt=2026-05-18&enddt=2026-06-17

Fractyl is evaluating Revita Duodenal Mucosal Resurfacing (DMR) in the REMAIN-1 pivotal study, which is designed to include two cohorts - an open label cohort referred to as REVEAL-1, and a randomized cohort, which includes both a midpoint analysis and a pivotal analysis. Patients who previously lost at least 15% of their body weight on a GLP-1 can qualify for the open label REVEAL-1 cohort. The data generated from the REVEAL-1 cohort will be used for open label reporting as the study progresses. The REMAIN-1 randomized cohort will enroll patients living with obesity and a body mass index ("BMI") between 30 and 45 kg/m2 who are not currently on a GLP-1 drug. Patients will be prescribed tirzepatide and titrated to achieve at least 15% total body weight loss, at which time tirzepatide will be discontinued and patients will be randomized to Revita versus sham at 2:1.

Midpoint Analysis of Randomized Cohort:

The midpoint analysis of the randomized cohort will be performed at three months of follow-up on approximately 45 patients, allowing us to assess and report on safety and efficacy signals that could be anticipated in the pivotal analysis. These patients are distinct from those included in the pivotal analysis.

Pivotal Analysis of Randomized Cohort:

The pivotal analysis of the randomized cohort will be performed on approximately 315 patients (distinct from those included in the midpoint analysis) and will evaluate safety and efficacy in the first co-primary endpoint, which is weight regain from the time of tirzepatide discontinuation in Revita DMR versus sham patients at six months, with a primary objective of demonstrating a benefit of Revita DMR versus sham for weight maintenance after GLP-1 discontinuation. The second co-primary endpoint evaluates a responder rate among the Revita DMR treated group at one year to demonstrate the durability of the Revita DMR procedure for weight maintenance after discontinuation of a GLP-1-based therapy.

Secondary objectives will include evaluation of the effectiveness of the Revita DMR procedure on the change in blood glucose levels, cardiovascular disease ("CVD") risk factors, body composition and pre-diabetes status. All patients enrolled in the study will receive diet and lifestyle counseling.

Evaluation of the Safety and Efficacy of Revita® DMR on Body Weight Maintenance in Subjects With Obesity Who Have Achieved at Least 15% Weight Loss on Tirzepatide