Fractyl Health Reports Positive One-Year REVEAL-1 Open-Label Results Showing Sustained Post-GLP-1 Weight Maintenance After a Single Revita® Procedure

Rhea-AI Summary

Fractyl Health (Nasdaq:GUTS) reported positive one-year open-label REVEAL-1 results for its Revita® procedure in people with obesity discontinuing GLP-1 drugs.

Participants maintained ~78% of prior GLP-1-induced weight loss; mean total body weight change was 5.3% (n=15). HbA1c rose only 0.08%, with no procedure-related serious adverse events. One-year randomized REMAIN-1 Midpoint data are expected in Q3 2026 and six-month Pivotal Cohort data in early Q4 2026.

Positive

• Participants maintained ~78% of GLP-1-induced weight loss at one year after Revita
• Mean total body weight change of 5.3% at one year in efficacy set (n=15)
• 100% of REVEAL-1 patients kept at least 5% of GLP-1-induced weight loss
• Minimal HbA1c change of 0.08% at one year after GLP-1 discontinuation
• No procedure-related serious adverse events; mild AEs were transient and early
• Randomized REMAIN-1 Midpoint and Pivotal data readouts expected in Q3 and early Q4 2026

Negative

• One-year efficacy outcomes based on 15 participants; full analysis set n=22
• REVEAL-1 is an open-label cohort without a randomized control arm
• Study not powered to assess ablation length dose-response effects

News Market Reaction – GUTS

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$120.57M Market Cap

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In the Jun 4 session, GUTS declined 3.47%, reflecting a moderate negative market reaction. Argus tracked a trough of -21.3% from its starting point during tracking. Our momentum scanner triggered 5 alerts that day, indicating moderate trading interest and price volatility.

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Market Context

This announcement highlights one-year open-label REVEAL-1 data supporting Revita’s potential for pos...

Analysis

This announcement highlights one-year open-label REVEAL-1 data supporting Revita’s potential for post‑GLP‑1 weight maintenance, including sustained weight loss and minimal HbA1c change at one year. It builds on prior disclosures of fully enrolled pivotal REMAIN-1, anticipated Q4 2026 readouts and cash runway into early 2027. Investors may watch for larger, randomized results, regulatory feedback and progress on the parallel Rejuva gene therapy program as key next milestones.

Key Figures

Mean weight change: 5.3% total body weight Weight loss maintained: 78% of prior GLP-1 loss Continued weight loss: 33% of patients +5 more

8 metrics

Mean weight change 5.3% total body weight One year after Revita; efficacy set n=15

Weight loss maintained 78% of prior GLP-1 loss Proportion of GLP-1-induced weight loss retained at one year

Continued weight loss 33% of patients Patients still losing weight one year post-GLP-1 discontinuation

Efficacy population 15 participants (n=15) Patients with complete one-year efficacy data in REVEAL-1

Safety population 22 participants Patients with safety data through one year in REVEAL-1

HbA1c change 0.08% ± 0.08% Mean change one year after Revita; n=15

Serious adverse events 0 procedure-related No procedure-related serious adverse events observed

Mild adverse events 8 of 22 (36%) Mild, transient treatment-emergent AEs within first month

Historical Context

5 past events · Latest: Jun 01 (Positive)

Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Jun 01	Senior hire	Positive	+7.6%	Hired SVP to build market access and commercial strategy for Revita launch.
May 12	Q1 2026 earnings	Positive	+29.2%	Reported net income, reduced R&D, solid cash and reaffirmed 2026 data milestones.
May 11	Gene therapy trial	Positive	+1.9%	Received Dutch authorization for first-in-human RJVA-001 trial in type 2 diabetes.
May 05	Earnings date, conference	Neutral	-4.6%	Announced upcoming Q1 results call and conference presentation details.
Mar 24	FY 2025 results	Positive	+16.2%	Reported FY 2025 results and pivotal Revita progress with anticipated Q4 2026 data.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Recent fundamentally positive milestones in Revita and Rejuva have often been followed by positive one-day price reactions, though occasional neutral/newsflow items have seen downside.

Recent Company History

Over recent months, Fractyl has advanced both its Revita and Rejuva programs while shoring up its commercial and regulatory path. Q4 2025 and Q1 2026 updates highlighted pivotal REMAIN-1 progress, cash runway into early 2027, and supportive FDA feedback, with shares reacting positively to these milestones. Additional news on the Dutch authorization for RJVA-001 and a senior market access hire similarly saw constructive moves, framing today’s open-label Revita data within a steadily building clinical and strategic narrative.

Key Terms

glp-1, hba1c, mmrm, duodenum, +4 more

8 terms

glp-1 medical

"Participants retained ~78% of GLP-1 induced total body weight loss one year..."

GLP-1 (glucagon-like peptide-1) is a natural hormone in the body that helps regulate blood sugar levels and appetite. Its significance to investors lies in its role as the basis for a class of medications that address conditions like type 2 diabetes and obesity, which are large and growing markets. Advances or investments in GLP-1-based treatments can signal opportunities in healthcare innovation and potentially impact pharmaceutical companies’ growth.

hba1c medical

"Sustained glycemic control through one year: Minimal change in HbA1c levels was observed..."

A1c (HbA1c) is a blood test that measures how much sugar has stuck to red blood cells over the past two to three months, giving a single number that reflects average blood glucose control—think of it as a running average score for blood sugar. Investors watch A1c because it’s a common clinical measure used to judge whether diabetes drugs, devices or care programs work, influence regulatory approvals, treatment guidelines and market demand.

mmrm medical

"0.08% ± 0.08%; LS means ± SE from MMRM; n=15"

MMRM is a statistical method used in clinical trials to analyze repeated measurements from the same patients over time, accounting for natural differences between individuals and for missing visits without simply guessing missing values. Think of it like comparing students’ test-score trends across semesters while recognizing each student’s pattern rather than averaging everyone together; for investors, MMRM matters because it influences how robust and reliable reported treatment effects appear, which can affect regulatory interpretation and market reaction.

duodenum medical

"Revita targets the duodenum, a root contributor to metabolic disease..."

The duodenum is the first section of the small intestine immediately past the stomach, acting like the intake chamber where food mixes with digestive juices to begin nutrient absorption. For investors, it matters because many drugs, medical devices, imaging tests and surgical procedures target or affect this area; outcomes, safety and regulatory approvals tied to the duodenum can influence clinical success and commercial value. Think of it as the kitchen sink where digestion’s next steps get started.

endoscopic medical

"through a single endoscopic procedure that fits within routine GI practice"

Endoscopic describes medical procedures or the instruments used to look inside the body with a thin, flexible tube that carries a light and tiny camera, often inserted through a small incision or a natural opening. It matters to investors because these less invasive approaches typically mean shorter hospital stays, lower complication rates and growing demand for specialized devices and disposable parts, which can shift revenue toward outpatient care and new technologies; think of it like a plumber’s snake with a camera that lets doctors fix problems without tearing open a wall.

upper endoscopy medical

"tolerability profile observed to date in line with a routine upper endoscopy"

A medical procedure that uses a thin, flexible tube with a tiny camera passed through the mouth to look inside the esophagus, stomach and first part of the small intestine; doctors can also take tissue samples or perform minor treatments through the tube. Investors care because the number of these procedures, the devices and disposable tools used, and their role as diagnostic or trial endpoints can affect revenue streams, regulatory decisions and the perceived effectiveness of treatments — like a window showing whether therapies or products are working.

full analysis set medical

"An efficacy estimand in the full analysis set demonstrated similar results..."

The full analysis set is the group of clinical trial participants whose data are included in the main effectiveness analyses — typically everyone who was enrolled, received treatment, and provided at least some follow-up data. For investors, this matters because the size and composition of that group affect how credible and representative the reported results are; it’s like judging a product by reading all customer reviews rather than a few selected ones.

pivotal cohort medical

"REM AIN-1 Pivotal Cohort in early Q4 2026"

A pivotal cohort is the main group of patients in a clinical trial whose results regulators and companies treat as the decisive test of a treatment’s safety and effectiveness. Investors pay attention because outcomes from this group often determine whether a product can win approval or reach the market, similar to a final exam or spotlight performance that can make or break a company’s prospects.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Participants retained ~78% of GLP-1 induced total body weight loss one year after discontinuation and a single Revita procedure

5.3% mean weight change observed with Revita (n=15); published third-party studies after GLP-1 withdrawal alone have shown ~15% weight regain at similar time points

33% of patients continued to lose further weight one year after discontinuing a GLP-1

Next anticipated Revita® clinical data readouts are one-year randomized data from the REMAIN-1 Midpoint Cohort in Q3 2026 and topline six-month randomized data from the REMAIN-1 Pivotal Cohort in early Q4 2026

BURLINGTON, Mass., June 04, 2026 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) (the Company or Fractyl), a clinical-stage metabolic therapeutics company focused on pioneering novel approaches to treat obesity and type 2 diabetes (T2D), today announced positive one-year results from its open-label REVEAL-1 Cohort. The REVEAL-1 Cohort is an open-label study in individuals with obesity who have lost at least 15% of their total body weight on a GLP-1 medication and who either need or choose to discontinue GLP-1 therapy. The REVEAL-1 data show that patients who underwent a single Revita procedure maintained approximately 78% of their prior GLP-1-induced weight loss at one year, with 33% of patients continuing to lose weight one year after discontinuing a GLP-1. The new results highlight Revita’s potential to be a compelling procedural therapy for post-GLP-1 weight maintenance.

Key Findings:

• Hard-to-treat GLP-1 responder population: Participants lost ~24% total body weight (>50 lbs.) on GLP-1 drugs prior to enrollment (duration on GLP-1 therapy ranging from five months to five years.) Patients were enrolled who had lost at least 15% total body weight on GLP-1 medicines, with 17 of 22 participants having greater than 17.5% total body weight loss on GLP-1 drugs. Safety and complete efficacy data through one year are available for 22 and 15 participants, respectively.
• Sustained weight maintenance through one year: Participants maintained stable weight after a single Revita procedure, with a mean total body weight change of 5.3% ± 2.1% (LS means ± SE; n=15) at one year. An efficacy estimand in the full analysis set demonstrated similar results, with mean total body weight change of 5.8% ± 2.0% (LS means ± SE; n=22). Participants retained ~78% of their drug-induced weight loss at one year. 33% of participants continued to lose weight at one year. Published third-party studies^1,2 report ~15% weight regain by this time point after GLP-1 withdrawal alone (see Figure 1 below). Across this cohort, ablation length clustered narrowly around its median ablation length and the study therefore does not have power to detect an ablation length dose response.
• 100% of patients in the REVEAL-1 Cohort maintained at least 5% of GLP-1-induced weight loss through one year: This ≥5% threshold is the responder definition used as the second co-primary endpoint in the REMAIN-1 Pivotal Cohort, which evaluates a responder rate among the Revita treated participants at one year to assess the durability of the Revita procedure for weight maintenance after GLP-1 discontinuation.
• Sustained glycemic control through one year: Minimal change in HbA1c levels was observed after the Revita procedure (0.08% ± 0.08%; LS means ± SE from MMRM; n=15), compared to the ~0.4% increase in HbA1c seen post-GLP-1 discontinuation in the STEP-1 trial extension² of GLP-1 withdrawal. This suggests Revita may help stabilize cardiometabolic parameters gained on GLP-1 therapy after the drug is stopped.
• Excellent tolerability: No procedure-related serious adverse events and no new treatment emergent adverse events were observed. Mild treatment-emergent adverse events occurred in eight of 22 participants (36%), were transient, self-limited, and all occurred within the first month of treatment. No late device-related adverse events were observed, and all adverse events were consistent with prior Revita experience and similar to routine upper endoscopy findings.
• Reproducible procedure performance: As previously reported, average ablation length was approximately 16 cm (n=22), consistent with Revita European real-world experience and the ongoing REMAIN-1 Pivotal study, supporting the potential translatability of results and scalability of technique.
  
  

Figure 1: Total Body Weight Change Over Time Following GLP-1 Discontinuation and Revita Treatment. GLP-1 weight loss from weeks -52 to 0 are illustrative based on average weight loss and time on medication in REVEAL-1 subjects. Projected regain citation: Budini et al., eClinicalMedicine. 2026;93:103796. FAS = full analysis set, GLP-1 = glucagon-like peptide-1, TBW = total body weight.

“As a gastroenterologist, what's compelling here is the mechanism and the simplicity. Revita targets the duodenum, a root contributor to metabolic disease, through a single endoscopic procedure that fits within routine GI practice,” said Dr. Shailendra Singh, Director of Bariatric Endoscopy at West Virginia University. “Seeing patients sustain their weight loss a full year after one procedure, without staying on chronic medication, shows the potential for Revita to be a meaningfully different option than what we have today. And with a tolerability profile observed to date in line with a routine upper endoscopy, this is the kind of durable, procedure-based approach I could see fitting naturally into how we care for these patients.”
        
“GLP-1 medicines have transformed obesity care, but they were never designed to be taken forever, and the field's answer so far has been to keep patients on a drug indefinitely. Even the newest maintenance strategies ask people to switch from a weekly medication to a daily medication, live with ongoing side effects, and still regain some of the weight they worked so hard to lose. That is not the off-ramp patients are asking for,” said Harith Rajagopalan, M.D., Ph.D., Co-Founder and Chief Executive Officer of Fractyl. “With one-year REVEAL-1 data now showing durable weight maintenance after a single Revita procedure, and without any continued drug therapy, we believe Revita points to a fundamentally different path: a potentially one-time, root-cause approach to holding onto weight loss after GLP-1 discontinuation. We look forward to building on these open-label results with complementary one-year randomized data from our REMAIN-1 Midpoint Cohort in Q3 2026, followed by topline results from our REMAIN-1 Pivotal Cohort in early Q4 2026.”

About REVEAL-1

The REVEAL-1 Cohort (n=22) is an open-label study in individuals living with obesity who have lost at least 15% of their total body weight on a GLP-1 medication and who either need or choose to discontinue GLP-1 therapy. After stopping the GLP-1 based therapy, participants receive Revita treatment in an open-label setting and take part in a structured diet and lifestyle program. REVEAL-1 is designed to provide early, real-world insights on how Revita performs after GLP-1 discontinuation.

To date, 22 participants have been treated in the REVEAL-1 Cohort and are included in safety and efficacy analyses. Five participants withdrew or were lost to follow up and two participants experienced protocol deviations. The profile of the REVEAL-1 Cohort closely mirrors that of the REMAIN-1 Midpoint and Pivotal Cohorts, with an average age of 50 and a gender distribution of 86% women. All 22 participants had previously been treated with a GLP-1 therapy for durations ranging from approximately 5 months to 5 years, with a mean total body weight loss of 24% while on therapy and a mean body weight of 80 kg ± 3 kg (SEM) at the time of intervention.

About Revita

Revita is Fractyl Health’s lead product candidate, designed to remodel the duodenal lining via a one-time, minimally invasive endoscopic procedure intended to restore healthy nutrient sensing and signaling disrupted by chronic metabolic disease. Revita has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for weight maintenance in people with obesity who discontinue GLP-1 therapies. Revita is for investigational use only in the United States and is CE marked in the European Union and United Kingdom.

About Fractyl Health

Fractyl Health is a clinical-stage metabolic therapeutics company advancing two differentiated candidates designed to target the root causes of obesity and T2D: Revita, a procedural therapy in pivotal development for post-GLP-1 weight maintenance, and Rejuva, an AAV-based gene therapy platform with its lead candidate RJVA-001 entering first-in-human clinical studies. Fractyl’s goal is to advance metabolic disease treatment from chronic management toward prevention and reversal of disease. Fractyl is headquartered in Burlington, Massachusetts.

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 are forward-looking statements. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, without limitation, statements regarding: the promise and potential impact of our clinical trial data and product candidates, including Revita’s potential for maintaining weight loss after GLP-1 based therapy discontinuation and stabilize cardiometabolic parameters; the translatability of results and scalability of technique related to Revita; the design, initiation, timing and results of clinical enrollment and any clinical studies or readouts, including readouts from the REMAIN-1 Midpoint Cohort and the REMAIN-1 Pivotal Cohort; 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; our strategic and product development objectives and goals; 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 our 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 risks that are discussed more fully in our filings with the Securities and Exchange Commission (the SEC) including the “Risk Factors” section of our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the SEC on March 24, 2026, and other documents we subsequently file with or furnish to the SEC, including our Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, filed with the SEC on May 12, 2026. These forward-looking statements are based on management’s current estimates and expectations. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.

Contact

Brian Luque, Head of Investor Relations and Corporate Development
IR@fractyl.com, 951.206.1200

^{¹ Aronne et al. JAMA. 2024;331(1):38–48. doi:10.1001/jama.2023.24945
² Wilding et al. Diabetes Obes Metab. 2022 Aug;24(8):1553-1564}

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/cfe8a68b-c93d-4766-9f1b-58dea83109bf 

FAQ

What did Fractyl Health (NASDAQ:GUTS) announce about the REVEAL-1 Revita trial on June 4, 2026?

Fractyl Health announced positive one-year open-label REVEAL-1 results for its Revita procedure in patients stopping GLP-1 drugs. According to Fractyl, participants retained about 78% of GLP-1-induced weight loss and showed minimal HbA1c change, with no procedure-related serious adverse events.

How much weight did REVEAL-1 participants maintain one year after GLP-1 discontinuation with Revita?

Participants maintained roughly 78% of their prior GLP-1-induced total body weight loss one year after Revita. According to Fractyl, mean total body weight change was 5.3% (n=15), and 33% of patients continued losing weight a year after stopping GLP-1 therapy.

What were the HbA1c outcomes in Fractyl Health's REVEAL-1 Revita study after GLP-1 withdrawal?

HbA1c change was minimal at one year following Revita in REVEAL-1. According to Fractyl, mean HbA1c shifted by only 0.08% (n=15), compared with about a 0.4% increase reported after GLP-1 discontinuation in the STEP-1 trial extension.

What safety results were reported for the Revita procedure in Fractyl Health's REVEAL-1 cohort?

Revita showed a favorable safety profile over one year in REVEAL-1. According to Fractyl, there were no procedure-related serious adverse events; mild treatment-emergent events occurred in 36% of participants, were transient, self-limited, and appeared only within the first month.

How many patients were included in Fractyl Health's REVEAL-1 Revita one-year analysis?

Safety data were available for 22 participants and efficacy data for 15 at one year. According to Fractyl, these individuals had previously lost at least 15% total body weight on GLP-1 drugs before receiving a single Revita procedure after discontinuation.

What upcoming Revita clinical milestones did Fractyl Health (GUTS) guide for 2026?

Fractyl highlighted two key Revita data readouts planned for 2026. According to Fractyl, one-year randomized data from the REMAIN-1 Midpoint Cohort are expected in Q3 2026, and six-month topline randomized Pivotal Cohort data are anticipated in early Q4 2026.

How does weight regain in REVEAL-1 compare with published data after GLP-1 withdrawal alone?

REVEAL-1 showed lower mean weight regain than some published GLP-1 withdrawal data. According to Fractyl, Revita-treated participants had a 5.3% mean weight change, while third-party studies have reported roughly 15% weight regain at similar time points after stopping GLP-1 without Revita.