BioAge Labs Begins Phase 1 Trial of Oral NLRP3 Inhibitor for Obesity
BioAge Labs has started human testing of BGE-102, an orally available NLRP3 inhibitor designed to cross the blood-brain barrier. The Phase 1 trial will evaluate safety, dosing, and biological activity, with early results expected by the end of 2025. The compound is initially being developed for obesity, after showing weight-loss effects in preclinical studies both alone and in combination with GLP-1 receptor agonists.
Image credit: BioAge Labs, BGE-102 Monotherapy
BGE-102 is described as structurally distinct from other NLRP3 inhibitors and targets a different binding site on the inflammasome. NLRP3 is a key driver of chronic inflammation linked to metabolic and neuroinflammatory diseases, and BioAge has developed a family of chemically novel inhibitors designed to address these conditions, with BGE-102 being their lead program.
Image credit: BioAge Labs, BGE-102 & semaglutide combination
Preclinical research reported up to 15% weight loss with BGE-102 alone, and about 25% when combined with semaglutide. The compound showed no adverse findings in toxicology studies and demonstrated brain penetration, supporting its potential application in obesity by modulating neuroinflammation that disrupts appetite regulation, as well as systemic inflammation tied to cardiovascular risk.
The randomized, double-blind, placebo-controlled Phase 1 trial will test both single and multiple ascending doses in healthy volunteers. The study includes pharmacokinetic profiling through blood sampling, assessment of central nervous system penetration via cerebrospinal fluid, and pharmacodynamic testing with an ex vivo assay measuring IL-1β inhibition.
The trial follows BioAge’s completion of IND-enabling studies earlier in 2025, part of a broader pipeline update reported in its Q2 financials. BioAge also continues to advance collaborations with Novartis and Eli Lilly in aging-related drug discovery.
BioAge Labs is a clinical-stage biopharmaceutical company developing therapies that target the biology of aging to treat obesity and metabolic diseases. Its computational discovery platform integrates longitudinal human aging data with proprietary multi-omics datasets from large cohorts to identify molecular drivers of lifespan and healthspan. Current programs include the oral, brain-penetrant NLRP3 inhibitor BGE-102 and multiple APJ agonists. The company is backed by investors including Andreessen Horowitz, AME Cloud Ventures, PEAR Ventures, Felicis Ventures, and Caffeinated Capital.
BioAge expects single ascending dose data by the end of 2025, with plans for a proof-of-concept obesity study in 2026. Top-line data from that study are anticipated by the end of 2026.
Topics: Clinical Trials
