Core Insights - BioAge Labs, Inc. has initiated a Phase 1 clinical trial for BGE-102, a novel orally available small molecule NLRP3 inhibitor aimed at treating obesity, with initial data expected by the end of 2025 and top-line results from the obesity study anticipated by the end of 2026 [1][6] Group 1: Product Development - BGE-102 is a structurally novel class of NLRP3 inhibitors, targeting age-related inflammation linked to various diseases, including obesity [2][7] - The compound has shown a strong safety profile in GLP toxicology studies, with no adverse findings reported [3][4] - In preclinical models, BGE-102 demonstrated dose-dependent weight loss of up to 15% as monotherapy and approximately 25% when combined with semaglutide, indicating its potential for an all-oral obesity treatment regimen [4][6] Group 2: Clinical Trial Design - The Phase 1 study is randomized, double-blind, and placebo-controlled, assessing safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy participants [5] - The trial consists of two parts: single ascending doses and multiple ascending doses administered once daily for 14 days, with evaluations of pharmacokinetic profiles and CNS penetration [5][6] Group 3: Strategic Vision - The CEO of BioAge expressed optimism about BGE-102's potential to complement existing therapies like GLP-1 agonists, enhancing weight loss and addressing neuroinflammation associated with obesity [6] - Following the Phase 1 study, BioAge plans to advance BGE-102 into a proof-of-concept study in obesity in 2026, with top-line data expected by the end of that year [6][8]
BioAge Labs Announces First Participant Dosed in Phase 1 Clinical Trial of BGE-102, a Novel Brain-Penetrant NLRP3 Inhibitor