Following a single subcutaneous 240 mg dose, WVE-007 (INHBE GalNAc-siRNA) improved body composition at three months compared to baseline, with a 9.4% reduction in visceral fat (p=0.02), a 4.5% reduction in total body fat (3.5 lbs; p=0.07), and a 3.2% increase in lean mass (4.0 lbs; p=0.01), with no statistically significant changes in the placebo group
Sustained and robust suppression of serum Activin E supports expectations for continued improvements in body composition, further fat loss, and preserved muscle, with once or twice-yearly dosing
Generally safe and well tolerated with only mild treatment related adverse events and no clinically meaningful changes in clinical laboratory measurements, including lipid profiles or liver function tests
Planning underway for Phase 2 trials evaluating WVE-007 both as a monotherapy and an add-on therapy to incretins in populations with higher BMI and related co-morbidities, and as maintenance post-incretin treatment
Further clinical data updates expected in 1Q 2026, including six-month follow-up from the 240 mg single-dose cohort and three-month follow-up from 400 mg single-dose cohort
Investor conference call and webcast at 8:30 a.m. ET today
CAMBRIDGE, Mass., Dec. 08, 2025 (GLOBE NEWSWIRE) -- Wave Life Sciences Ltd. (NASDAQ:WVE), a clinical-stage biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health, today announced positive interim data from the lowest therapeutic cohort of the ongoing first-in-human INLIGHT trial evaluating WVE-007, an investigational INHBE GalNAc-siRNA using Wave's proprietary SpiNA design, for the treatment of obesity. In this interim assessment, a single 240 mg dose of WVE-007 led to an improvement in body composition characterized by reductions in total and visceral fat mass at three months and an increase in lean mass. There was also a favorable safety profile as well as durable reductions in serum Activin E that support potential once or twice-yearly dosing.
These results add to a growing body of data supporting the silencing of INHBE and its downstream protein product (Activin E) as a therapeutic approach to obesity with strong evidence from human genetics. Individuals who have a protective loss-of-function variant in one copy of the INHBE gene have a healthier body composition and cardiometabolic profile, including less visceral fat and lower risk of developing type 2 diabetes and cardiovascular disease. Importantly, visceral fat on its own is closely associated with many diseases, including cardiometabolic disorders.