Fractyl Health received Clinical Trial Application authorization in the Netherlands on May 11, 2026 to initiate a Phase 1/2 first-in-human study of RJVA-001, the lead clinical candidate from its Rejuva Smart GLP-1 gene therapy platform.
According to the company, RJVA-001 is an adeno-associated virus based, beta-cell targeted, one-time gene therapy designed to enable nutrient-responsive, physiologic GLP-1 expression within the pancreas and to avoid the high circulating drug levels associated with systemic GLP-1 therapy; it is delivered via a minimally invasive endoscopic ultrasound-guided intrapancreatic infusion.
The open-label, multicenter, single-ascending-dose trial will enroll adults aged 35–70 with type 2 diabetes inadequately controlled despite multiple glucose-lowering agents, including GLP-1 receptor agonists; the protocol includes three escalating dose cohorts of three participants each followed by an optional expansion cohort of up to 20 participants, with 12 months of on-study safety and efficacy monitoring and up to five years of long-term follow-up.
Fractyl expects first-in-human dosing and preliminary data in the second half of 2026, subject to site activation, and plans to seek additional sites in Australia. The company says Rejuva clinical development is funded within its existing cash runway into early 2027 and notes that no Investigational New Drug application has been filed with the U.S. Food and Drug Administration.
