BioAge Labs has dosed the first participant in QUELL-CV, a randomized, double-blind, placebo-controlled, dose-ranging Phase 2 proof-of-concept trial evaluating BGE-102 in approximately 160 adults at elevated cardiovascular risk.
The 12-week trial will test three once-daily oral doses (30 mg, 60 mg, 90 mg) versus placebo with a primary endpoint of percent change in high-sensitivity C-reactive protein (hsCRP) and additional endpoints including the proportion achieving hsCRP normalization (<2 mg/L) and other inflammatory, cardiometabolic and imaging biomarkers.
BGE-102 is an orally available, brain-penetrant small-molecule NLRP3 inhibitor being developed with cardiovascular risk reduction as the lead indication.
According to the company, a Phase 1 SAD/MAD trial in healthy volunteers and participants with obesity and elevated inflammation showed median hsCRP reductions of 86% at selected doses, favorable pharmacokinetics and a tolerable safety profile. The company claims BGE-102 demonstrated potential best-in-class hsCRP reductions in Phase 1 and plans a Phase 1b/2a diabetic macular edema study in mid-2026, with QUELL-CV topline data anticipated in the second half of 2026.
