Fractyl Health Reports Positive Early Data Showing Revita® Has Potential to Prevent Weight Regain After GLP-1 Discontinuation
Fractyl Health (NASDAQ: GUTS) has reported promising early data from its REVEAL-1 study, suggesting that its Revita® procedure may help prevent weight regain after patients discontinue GLP-1 medications. The study shows that at 1-month post-procedure, 7 patients experienced an average weight regain of just 1.2%, compared to the typical 3% regain observed after GLP-1 discontinuation.
The REVEAL-1 cohort, part of the ongoing REMAIN-1 pivotal study, has treated 15 patients to date, with no safety or tolerability concerns reported. This safety profile aligns with previous data from over 100 treated patients. The company's REMAIN-1 pivotal study is now more than 50% enrolled, with a midpoint data analysis expected in Q3 2025.
Revita, which holds FDA Breakthrough Device designation, is being studied under an open Investigational Device Exemption. The company aims to position it as the first approved intervention specifically for post-GLP-1 weight maintenance, addressing a growing unmet need in obesity treatment.
Fractyl Health (NASDAQ: GUTS) ha riportato dati preliminari promettenti dal suo studio REVEAL-1, suggerendo che la procedura Revita® potrebbe aiutare a prevenire il recupero di peso dopo che i pazienti interrompono i farmaci GLP-1. Lo studio mostra che a 1 mese dopo la procedura, 7 pazienti hanno sperimentato un recupero di peso medio di solo l'1,2%, rispetto al tipico 3% di recupero osservato dopo l'interruzione dei farmaci GLP-1.
Il gruppo REVEAL-1, parte dello studio pivotale in corso REMAIN-1, ha trattato finora 15 pazienti, senza segnalazioni di preoccupazioni relative alla sicurezza o alla tollerabilità. Questo profilo di sicurezza è in linea con i dati precedenti di oltre 100 pazienti trattati. Lo studio pivotale REMAIN-1 dell'azienda è ora oltre il 50% di iscrizione, con un'analisi dei dati prevista per il terzo trimestre del 2025.
Revita, che ha ottenuto la designazione di Dispositivo Innovativo dalla FDA, è attualmente in fase di studio sotto un'esenzione investigativa per dispositivi. L'azienda mira a posizionarlo come il primo intervento approvato specificamente per il mantenimento del peso dopo il GLP-1, affrontando un bisogno crescente e non soddisfatto nel trattamento dell'obesità.
Fractyl Health (NASDAQ: GUTS) ha reportado datos preliminares prometedores de su estudio REVEAL-1, sugiriendo que el procedimiento Revita® podría ayudar a prevenir el aumento de peso después de que los pacientes suspenden los medicamentos GLP-1. El estudio muestra que a 1 mes después del procedimiento, 7 pacientes experimentaron un aumento de peso promedio de solo el 1.2%, en comparación con el típico 3% de aumento observado tras la discontinuación de GLP-1.
El grupo REVEAL-1, parte del estudio pivotal en curso REMAIN-1, ha tratado hasta la fecha a 15 pacientes, sin que se hayan reportado preocupaciones sobre la seguridad o la tolerabilidad. Este perfil de seguridad está alineado con datos previos de más de 100 pacientes tratados. El estudio pivotal REMAIN-1 de la compañía está ahora más del 50% inscrito, con un análisis de datos esperado para el tercer trimestre de 2025.
Revita, que tiene la designación de Dispositivo Innovador por parte de la FDA, se está estudiando bajo una Exención de Dispositivo Investigacional. La compañía tiene como objetivo posicionarlo como la primera intervención aprobada específicamente para el mantenimiento del peso posterior a GLP-1, abordando una necesidad creciente no satisfecha en el tratamiento de la obesidad.
Fractyl Health (NASDAQ: GUTS)는 REVEAL-1 연구에서 유망한 초기 데이터를 보고하여 Revita® 절차가 환자들이 GLP-1 약물을 중단한 후 체중 재증가를 방지하는 데 도움이 될 수 있음을 시사했습니다. 연구 결과, 절차 후 1개월에 7명의 환자가 평균 1.2%의 체중 재증가를 경험했으며, 이는 GLP-1 중단 후 관찰된 전형적인 3% 재증가와 비교됩니다.
REVEAL-1 집단은 현재 진행 중인 REMAIN-1 주요 연구의 일환으로, 현재까지 15명의 환자를 치료했으며, 안전성이나 내약성에 대한 우려는 보고되지 않았습니다. 이 안전성 프로필은 100명 이상의 치료받은 환자에서의 이전 데이터와 일치합니다. 회사의 REMAIN-1 주요 연구는 현재 50% 이상 등록되었으며, 2025년 3분기에 중간 데이터 분석이 예상됩니다.
FDA 혁신 장치 지정을 받은 Revita는 개방형 조사 장치 면제 하에 연구되고 있습니다. 회사는 GLP-1 이후 체중 유지에 특별히 승인된 첫 번째 개입으로 자리매김하는 것을 목표로 하여 비만 치료에서 증가하는 충족되지 않은 필요를 해결하고자 합니다.
Fractyl Health (NASDAQ: GUTS) a rapporté des données préliminaires prometteuses de son étude REVEAL-1, suggérant que la procédure Revita® pourrait aider à prévenir la reprise de poids après l'arrêt des médicaments GLP-1 par les patients. L'étude montre qu'un mois après la procédure, 7 patients ont connu une reprise de poids moyenne de seulement 1,2%, par rapport à la reprise typique de 3% observée après l'arrêt des GLP-1.
La cohorte REVEAL-1, qui fait partie de l'étude pivotale en cours REMAIN-1, a traité jusqu'à présent 15 patients, sans signalements de préoccupations concernant la sécurité ou la tolérabilité. Ce profil de sécurité est en accord avec les données précédentes de plus de 100 patients traités. L'étude pivotale REMAIN-1 de l'entreprise est maintenant inscrite à plus de 50%, avec une analyse des données prévue pour le troisième trimestre 2025.
Revita, qui détient la désignation de Dispositif Innovant par la FDA, est étudié dans le cadre d'une exemption d'enquête sur les dispositifs. L'entreprise vise à le positionner comme la première intervention approuvée spécifiquement pour le maintien du poids après le GLP-1, répondant à un besoin croissant non satisfait dans le traitement de l'obésité.
Fractyl Health (NASDAQ: GUTS) hat vielversprechende frühe Daten aus seiner REVEAL-1-Studie veröffentlicht, die darauf hindeuten, dass das Revita®-Verfahren helfen könnte, eine Gewichtszunahme zu verhindern, nachdem Patienten die GLP-1-Medikamente abgesetzt haben. Die Studie zeigt, dass 7 Patienten 1 Monat nach dem Verfahren im Durchschnitt nur 1,2% an Gewicht zugenommen haben, verglichen mit den typischen 3%, die nach der Absetzung von GLP-1 beobachtet werden.
Die REVEAL-1-Kohorte, die Teil der laufenden REMAIN-1-Hauptstudie ist, hat bisher 15 Patienten behandelt, ohne dass Sicherheits- oder Verträglichkeitsprobleme gemeldet wurden. Dieses Sicherheitsprofil stimmt mit früheren Daten von über 100 behandelten Patienten überein. Die REMAIN-1-Hauptstudie des Unternehmens ist nun zu mehr als 50% eingeschrieben, mit einer Datenanalyse zur Halbzeit, die im dritten Quartal 2025 erwartet wird.
Revita, das von der FDA die Auszeichnung als Durchbruch-Gerät erhalten hat, wird im Rahmen einer offenen Ermittlungsgerätevorschrift untersucht. Das Unternehmen strebt an, es als die erste genehmigte Intervention speziell zur Gewichtserhaltung nach GLP-1 zu positionieren und damit einem wachsenden unerfüllten Bedarf in der Behandlung von Fettleibigkeit gerecht zu werden.
- Early data shows only 1.2% weight regain vs typical 3% after GLP-1 discontinuation
- FDA Breakthrough Device designation obtained for post-GLP-1 weight maintenance
- REMAIN-1 pivotal study over 50% enrolled
- Strong safety profile with no concerns in over 100 treated patients
- data sample size (only 7 patients with 1-month data)
- Short follow-up period (only 1-month data available)
- Final study results not expected until Q3 2025
Insights
Fractyl's early REVEAL-1 data presents an intriguing potential solution to one of the most significant challenges in obesity treatment: weight maintenance after GLP-1 discontinuation. The 1.2% average weight regain at one month post-procedure compared to the typical ~3% suggests Revita may address the biological mechanisms driving weight regain.
However, these results come with important limitations. Data from only 7 patients with just one month of follow-up represents extremely preliminary evidence. Weight maintenance typically becomes more challenging beyond this timeframe, as compensatory metabolic adaptations intensify.
Mechanistically, Revita appears to target gut dysfunction as a root cause of obesity through a one-time procedure, potentially offering a fundamentally different approach than continued pharmacotherapy. The consistent safety profile across 100+ treated patients is encouraging for a procedural intervention.
The FDA's Breakthrough Device designation validates the unmet need Revita addresses, potentially accelerating regulatory review. With REMAIN-1 pivotal study >50% enrolled and midpoint analysis expected in Q3 2025, we're approaching critical validation milestones that will provide more definitive evidence of efficacy. If successful, Revita could establish a new treatment paradigm for post-GLP-1 weight maintenance.
Fractyl's early Revita data opens a potentially significant commercial opportunity addressing a critical gap in the obesity treatment landscape. As GLP-1 adoption continues accelerating worldwide, the growing discontinuation rates create a substantial addressable market for solutions preventing weight regain.
The current GLP-1 market faces challenges including medication costs, injection fatigue, side effects, and supply constraints - all contributing to discontinuation. A one-time procedural intervention could present a compelling economic and practical alternative to indefinite medication use.
From a market positioning perspective, Fractyl is targeting a strategic niche as the first approved intervention specifically for post-GLP-1 weight maintenance. This differentiated positioning avoids direct competition with GLP-1 manufacturers while potentially capturing patients transitioning off these medications.
The multiple data readouts expected throughout 2025 provide several potential value-creating catalysts. The midpoint analysis in Q3 2025 will be particularly crucial, as more robust evidence with longer follow-up and larger patient numbers will better define Revita's commercial potential.
For Fractyl, establishing Revita as an essential component in the obesity treatment continuum could create a sustainable business model complementary to, rather than competitive with, the expanding GLP-1 market - addressing the critical "what happens after GLP-1s" question that currently lacks good answers.
New REVEAL-1 study results show early signs of weight maintenance after GLP-1 discontinuation
REMAIN-1 pivotal study now more than
BURLINGTON, Mass., April 01, 2025 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (“the Company”), a metabolic therapeutics company focused on pattern breaking approaches that treat root causes of obesity and type 2 diabetes (T2D), today announced positive early data from the open-label REVEAL-1 cohort of its ongoing REMAIN-1 pivotal study. The results suggest that Revita, the Company’s novel approach to targeting gut dysfunction, a root cause of obesity, may help prevent weight regain after patients stop GLP-1 drugs—addressing a growing unmet need in obesity treatment. As global GLP-1 adoption accelerates—and discontinuation rates climb—the need for scalable, non-pharmacologic solutions to sustain weight loss presents a significant, underleveraged commercial opportunity.
Early Data Shows Evidence of Weight Maintenance and Reinforces Revita’s Favorable Safety and Tolerability Profile
To-date, 15 patients have been treated in the REVEAL-1 cohort, with 1-month data available for the first 7 patients. These patients have been treated with a GLP-1 drug for up to 3 years before discontinuing medication, undergoing a single Revita procedure, and continuing a structured diet and lifestyle program.
Key findings include:
- No safety or tolerability concerns reported in the 15 patients treated to date, consistent with Revita’s favorable safety profile from pooled data across more than 100 treated patients.
- At 1-month post-procedure, 7 patients experienced an average weight regain of just
1.2% , compared to the ~3% typically observed at this time period after GLP-1 discontinuation based on prior clinical studies1.
"Stopping GLP-1 drugs often feels like a cliff for many patients—they fear regaining the weight they worked so hard to lose," said Mohammad Othman, M.D., William T. Butler Endowed Chair and Professor of Medicine at Baylor College of Medicine. "These early data suggest that a well-tolerated, one-time procedure like Revita could offer patients a new, sustainable path forward without the need for ongoing medical treatment."
"The real challenge in obesity care isn’t just helping patients lose weight—it’s helping them keep it off," said Harith Rajagopalan, M.D., Ph.D., Co-Founder and CEO of Fractyl Health. "For the first time, we’re seeing early clinical data suggesting that Revita may offer a durable metabolic reset to help patients maintain their weight loss after GLP-1 therapy. I’m encouraged by these initial findings, and if they are confirmed in larger studies with longer follow-up, Revita has the potential to become a transformative option for patients at risk of weight regain."
Upcoming Data Milestones
Fractyl anticipates several key milestones for Revita in 2025:
- Additional REVEAL-1 patient follow-up data expected in Q2 2025
- Full REMAIN-1 pivotal study enrollment anticipated in summer 2025
- Midpoint analysis of REMAIN-1 pivotal study expected in Q3 2025
Revita is currently being studied under an open Investigational Device Exemption (IDE) in the U.S. and holds FDA Breakthrough Device designation for weight maintenance in patients discontinuing GLP-1 therapy. The Company aims to position Revita as the first approved intervention specifically for post-GLP-1 weight maintenance.
About Fractyl Health
Fractyl Health is a metabolic therapeutics company focused on pioneering new approaches to the treatment of metabolic diseases, including obesity and T2D. Despite advances in treatment over the last 50 years, obesity and T2D continue to be rapidly growing drivers of morbidity and mortality in the 21st century. Fractyl Health’s goal is to transform metabolic disease treatment from chronic symptomatic management to durable disease-modifying therapies that target the organ-level root causes of disease. Fractyl Health is based in Burlington, MA. For more information, visit www.fractyl.com.
About Revita®
Fractyl Health’s lead product candidate, Revita, is based on the company’s insights surrounding the potential role of the gut in obesity. Revita is designed to remodel the duodenal lining via hydrothermal ablation (i.e. duodenal mucosal resurfacing) to reverse damage to intestinal nutrient sensing and signaling mechanisms caused by chronic high-fat and high-sugar diets that are a root cause of metabolic disease. In the U.S., Revita is for investigational use only under U.S. law. Revita has U.S. FDA Breakthrough Device designation in weight maintenance for people with obesity who discontinue GLP-1 based drugs. A pivotal study of Revita in patients with obesity after discontinuation of GLP-1 based drugs, called REMAIN-1, was initiated in the third quarter of 2024 and is currently enrolling.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding the promise and potential impact of our preclinical or clinical trial data, the design, initiation, timing and results of clinical enrollment and any clinical studies or readouts, communications with regulators, the potential launch or commercialization of any of our product candidates or products, the potential treatment population or benefits for any of our product candidates or products, and our strategic and product development objectives and goals, including with respect to enabling long-term control over obesity and type 2 diabetes without the burden of chronic therapies, and the timing of any of the foregoing. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause the Company’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the Company’s limited operating history; the incurrence of significant net losses and the fact that the Company expects to continue to incur significant net losses for the foreseeable future; the Company’s need for substantial additional financing; the Company’s ability to continue as a going concern; the restrictive and financial covenants in the Company’s credit agreement; the lengthy and unpredictable regulatory approval process for the Company’s product candidates; uncertainty regarding its clinical studies; the fact that the Company’s product candidates may cause serious adverse events or undesirable side effects or have other properties that may cause it to suspend or discontinue clinical studies, delay or prevent regulatory development, prevent their regulatory approval, limit the commercial profile, or result in significant negative consequences; the Company’s reliance on third parties to conduct certain aspects of the Company’s preclinical studies and clinical studies; the Company’s reliance on third parties for the manufacture of sub-assembly components for Revita, and its ongoing clinical studies; the regulatory approval process of the FDA, comparable foreign regulatory authorities and lengthy, time-consuming and inherently unpredictable, and even if we complete the necessary clinical studies, we cannot predict when, or if, we will obtain regulatory approval or certification for any of our product candidates, and any such regulatory approval or certification may be for a more narrow indication than we seek; and the potential launch or commercialization of any of Company’s product candidates or products and our strategic and product development objectives and goals, and the other factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on March 3, 2025 and in our other filings with the SEC. These forward-looking statements are based on management’s current estimates and expectations. While the Company may elect to update such forward-looking statements at some point in the future, the Company disclaims any obligation to do so, even if subsequent events cause its views to change.
Contacts
Media Contact
Jessica Cotrone, Head of Corporate Communications
jcotrone@fractyl.com, 978.760.5622
Investor Contact
Brian Luque, Head of Investor Relations and Corporate Development
IR@fractyl.com, 951.206.1200
1 Aronne LJ, Sattar N, Horn DB, et al. Continued Treatment with Tirzepatide for Maintenance of Weight Reduction in Adults with Obesity. Jama 2023;331(1):38–48.
FAQ
What are the early results of Fractyl Health's REVEAL-1 study for GUTS stock?
When will Fractyl Health (GUTS) release the REMAIN-1 pivotal study results?
What is the FDA status of Fractyl Health's Revita procedure?
How many patients have been treated with Revita in Fractyl Health's clinical studies?
