On October 8, 2025, Fractyl Health announced potent new preclinical data from its second Rejuva platform candidate, RJVA‑002, a dual GIP/GLP‑1 gene therapy for obesity. The data were presented at the 2025 Cell & Gene Meeting and show that a single administration of RJVA‑002 produced approximately 30% weight loss in a diet‑induced obesity mouse model over five weeks. The weight loss trajectory had not yet plateaued, indicating sustained efficacy.
The study used male mice engineered to express a humanized GIP receptor and fed a 60% high‑fat diet to induce obesity. Mice received either vehicle, RJVA‑001 mid‑dose, RJVA‑002 mid‑dose, or RJVA‑002 high‑dose (n=7 per group). RJVA‑002 mid‑dose mice lost 18% of body weight (p<0.01) and high‑dose mice lost 29% (p<0.0001) by day 35, with no adverse effects observed.
These results demonstrate the platform’s ability to deliver durable, nutrient‑responsive hormone expression and support the potential of RJVA‑002 to match or exceed best‑in‑class chronic drug therapy for obesity. CEO Harith Rajagopalan said the data “further support our Smart GLP‑1 gene therapy platform approach and suggest that dual gut hormone expression has the potential to produce powerful metabolic effects.” The company plans to present additional data at an upcoming scientific congress.
RJVA‑002 expands the Rejuva platform from type‑2 diabetes to obesity, offering a one‑time intervention that could provide durable, well‑tolerated weight loss. With RJVA‑001 expected to enter first‑in‑human trials in 2026, the new preclinical data strengthen Fractyl’s portfolio and may accelerate the company’s path to market entry.
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