{"id":960605,"date":"2026-05-11T07:04:09","date_gmt":"2026-05-11T11:04:09","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/fractyl-health-authorized-to-initiate-first-in-human-trial-of-rjva-001-in-the-netherlands-first-gene-therapy-candidate-to-enter-clinical-development-for-type-2-diabetes\/"},"modified":"2026-05-11T07:04:09","modified_gmt":"2026-05-11T11:04:09","slug":"fractyl-health-authorized-to-initiate-first-in-human-trial-of-rjva-001-in-the-netherlands-first-gene-therapy-candidate-to-enter-clinical-development-for-type-2-diabetes","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/fractyl-health-authorized-to-initiate-first-in-human-trial-of-rjva-001-in-the-netherlands-first-gene-therapy-candidate-to-enter-clinical-development-for-type-2-diabetes\/","title":{"rendered":"Fractyl Health Authorized to Initiate First-in-Human Trial of RJVA-001 in the Netherlands: First Gene Therapy Candidate to Enter Clinical Development for Type 2 Diabetes"},"content":{"rendered":"
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\n Authorization advances Fractyl Health to a dual clinical-stage company, with Revita<\/em>
\n
\n \u00ae<\/em>
\n <\/sup>
\n in pivotal development for post-GLP-1 weight maintenance and Rejuva<\/em>
\n
\n \u00ae<\/em>
\n <\/sup>
\n entering first-in-human studies for type 2 diabetes<\/em>\n <\/p>\n

\n First-in-human dosing and preliminary data expected in the second half of 2026, subject to site activation<\/em>\n <\/p>\n

\n Rejuva<\/em>
\n \u00ae<\/sup>
\n clinical development funded within existing cash runway into early 2027, beyond anticipated REMAIN-1 Pivotal data readout; no change to capital plans<\/em>\n <\/p>\n

BURLINGTON, Mass., May 11, 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 that it has received Clinical Trial Application authorization in the Netherlands to initiate the Phase 1\/2 first-in-human study of RJVA-001, the first clinical candidate from the Company\u2019s Rejuva\u00ae<\/sup> Smart GLP-1\u2122 gene therapy platform. With this authorization, Fractyl believes RJVA-001 is the first adeno-associated virus (AAV)-based gene therapy candidate to enter clinical development for T2D, and Fractyl now advances to a dual clinical-stage company, with Revita\u00ae<\/sup> in pivotal development for post-GLP-1 weight maintenance and Rejuva entering first-in-human studies for T2D in the Netherlands. Pending site activation, Fractyl expects to dose the first patient with RJVA-001 and report preliminary data in the second half of 2026.<\/p>\n

RJVA-001 is a one-time, beta-cell\u2013targeted gene therapy designed to enable nutrient-responsive, physiologic GLP-1 expression within the pancreas, potentially avoiding the high circulating drug levels that contribute to side effects seen with systemic GLP-1 therapy. RJVA-001 is delivered via a minimally invasive endoscopic ultrasound-guided infusion directly into the pancreas, where it harnesses a proprietary, engineered version of the human insulin promoter and trafficking signals to drive nutrient-triggered secretion of GLP-1 from transduced pancreatic beta cells.<\/p>\n

“GLP-1 medicines have changed what is possible in obesity and type 2 diabetes, but they require chronic, high-dose systemic exposure that many patients cannot or do not sustain. RJVA-001 takes a different path: a potential one-time, pancreas-targeted gene therapy designed to enable the body to produce GLP-1 in response to meals: physiology, not pharmacology,\u201d said Harith Rajagopalan, MD PhD, Co-Founder and CEO of Fractyl Health. \u201cWith this authorization, RJVA-001 becomes the first AAV gene therapy candidate to enter clinical development for type 2 diabetes. We are funding Rejuva’s clinical development within our existing cash runway, beyond the anticipated REMAIN-1 Pivotal readout, with no change to our capital plans. We expect to dose the first patient and report initial data in the second half of 2026.”<\/p>\n

\u201cFor decades, we have managed T2D as a chronic, progressive disease that inevitably worsens over time. With this authorization, we are preparing to test, for the first time in humans, whether a one-time, pancreas-targeted gene therapy delivered via a routine endoscopic procedure could provide durable metabolic control by enabling physiologic, nutrient-responsive GLP-1 expression at the source of disease,\u201d said Professor Jacques Bergman, M.D., Ph.D., Professor of Gastrointestinal Endoscopy and Deputy Chair, Department of Gastroenterology & Hepatology at Amsterdam UMC, and a Principal Investigator of the RJVA-001 first-in-human study. \u201cPatients who remain inadequately controlled despite maximally tolerated GLP-1 receptor agonists (GLP-1RAs) and multiple oral agents represent a population with significant unmet need. If successful, RJVA-001 could transform how we think about T2D, from a chronic disease you manage every day to one that could potentially be treated once.\u201d<\/p>\n

\n About the RJVA-001 First-in-Human Study<\/strong>\n <\/p>\n

The Phase 1\/2 study is an open-label, multicenter, single-ascending-dose, first-in-human trial evaluating the safety, tolerability, and preliminary efficacy of RJVA-001 in adults with inadequately controlled T2D despite use of multiple glucose-lowering agents, including GLP-1RAs. Fractyl also plans to conduct the study at sites in Australia, where a clinical trial application has been submitted and regulatory feedback is expected in the third quarter of 2026.<\/p>\n

Participants will undergo a standardized medication run-in and GLP-1 washout before receiving RJVA-001 delivered via endoscopic ultrasound-guided intrapancreatic infusion. Three escalating dose cohorts (3 participants each) will be followed by an optional expansion cohort of up to 20 additional participants treated at the selected optimal dose. Participants will be monitored for 12 months for safety, glucose control, immune response, and GLP-1 expression, and enrolled in a long-term follow-up study for up to 5 years.<\/p>\n

\n Key inclusion criteria:<\/strong>\n <\/p>\n