Weekly Rundown: GLP-1 gene therapy enters first human trial FDA leadership changes, pharma deals, clinical trials, and more led the news this week. Written byDDN editorial team

https://www.drugdiscoverynews.com/weekly-rundown-glp-1-gene-therapy-enters-first-human-trial-17175 Fractyl Health received clinical trial authorization in the Netherlands this week to begin a first-in-human study of RJVA-001. The therapy takes a fundamentally different approach to GLP-1 treatment: Rather than delivering the hormone systemically through chronic injectable or oral drugs, RJVA-001 is designed as a one-time, endoscopically delivered infusion directly into the pancreas, where it reprograms beta cells to produce GLP-1 naturally in response to meals. The goal is physiologic hormone signaling at low circulating levels, potentially sidestepping the nausea, tolerability issues, and chronic dosing burden that cause many patients to discontinue existing GLP-1 therapies. The Phase 1/2 study will enroll adults with inadequately controlled type 2 diabetes who are already on GLP-1 receptor agonists and multiple oral agents, with first patient dosing and preliminary data expected in the second half of 2026. Fractyl also has a clinical trial application pending in Australia. For drug developers watching the GLP-1 space, RJVA-001 represents an early but notable test of whether gene therapy can move from managing metabolic disease to potentially treating it once. – Andrea Corona