BioAge Labs has dosed the first participant in the Phase 1 clinical trial of BGE-102, according to the company. The trial marks the first-in-human study of this orally available, brain-penetrant small-molecule NLRP3 inhibitor, initially developed for obesity. BGE-102 belongs to a structurally novel class of compounds designed to inhibit the NLRP3 inflammasome, a driver of age-related inflammation linked to obesity and other diseases.
According to the company, BGE-102 demonstrated high potency compatible with once-daily oral dosing and has shown strong CNS penetration in preclinical studies. The compound also exhibited a favorable safety profile in GLP toxicology studies. In obesity models, BGE-102 as monotherapy achieved up to 15 percent dose-dependent weight loss, while combination with semaglutide produced approximately 25 percent weight reduction, the company said.
The randomized, double-blind, placebo-controlled Phase 1 trial is structured in two parts: single ascending doses followed by multiple ascending doses administered once daily over 14 days. The study aims to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics, including CNS penetration and inflammatory biomarker inhibition.
The company said that initial single ascending dose data are expected by the end of 2025. Following that, BioAge plans to advance BGE-102 into a proof-of-concept obesity study in 2026, with top-line results anticipated by year-end.
