BioAge Labs, a clinical-stage biotechnology company developing therapies for metabolic diseases by targeting the biology of human aging, announced that the first participant has been dosed in its Phase 1 clinical trial of BGE-102, a structurally novel, orally available small-molecule NLRP3 inhibitor with high potency and brain penetration. BGE-102 is initially being developed for the treatment of obesity.

BGE-102 represents a new class of NLRP3 inhibitors with a unique binding mechanism distinct from other programs in development. NLRP3 is a key driver of age-related inflammation implicated in obesity, cardiovascular disease, and neurodegenerative conditions. Preclinical studies have demonstrated that BGE-102 achieves once-daily oral potency with strong CNS penetration. In obesity models, monotherapy produced dose-dependent weight loss of up to 15%, comparable to semaglutide, while combination with semaglutide resulted in approximately 25% weight loss. The compound was also well tolerated in GLP toxicology studies with no adverse findings.

The randomized, double-blind, placebo-controlled Phase 1 study is designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BGE-102 in healthy participants. The trial includes a single ascending dose phase and a multiple ascending dose phase with once-daily dosing over 14 days. Investigators will assess BGE-102’s pharmacokinetic profile through blood sampling, evaluate CNS penetration via cerebrospinal fluid sampling, and measure pharmacodynamic effects by examining inhibition of key inflammatory signals such as IL-1β.

“Dosing the first participant in the BGE-102 Phase 1 trial is a significant milestone in our mission to target the biology of aging,” said Kristen Fortney, PhD, CEO and co-founder of BioAge. “By inhibiting NLRP3-driven inflammation, BGE-102 has the potential to complement existing therapies like GLP-1s, delivering enhanced weight loss with the convenience of once-daily oral dosing. Its exceptional brain penetration uniquely positions it to address neuroinflammation in obesity and related conditions.”

Initial data from the single ascending dose portion of the study is expected by year-end 2025, with additional data from the multiple ascending dose portion to follow in 2026. BioAge plans to advance BGE-102 into a proof-of-concept obesity study in 2026, with top-line results anticipated by the end of that year.