BioAge plots clinical trial of NLRP3 inhibitor this year

Company targets obesity after IND-enabling studies demonstrate positive weight loss results both standalone and in combination with GLP-1s.

Longevity biotech BioAge Labs has announced the completion of investigational new drug (IND)-enabling studies for BGE-102, the company’s novel small-molecule NLRP3 inhibitor, as it advances toward clinical development. BGE-102 is designed as an orally available, brain-penetrant compound with high potency, and it is being developed initially for the treatment of obesity.

BioAge now plans to submit an IND application in mid-2025 and expects to begin a Phase 1 clinical trial shortly thereafter. The trial will include both single ascending dose and multiple ascending dose components, with first data expected by the end of the year. A Phase 1b proof-of-concept study in obese patients is anticipated to follow in the second half of 2026, contingent upon successful results from the initial clinical stage.

Following last year’s discontinuation of a Phase 2 clinical trial of its initial lead program azelaprag on safety grounds, BioAge has refocused its efforts on other promising avenues, including NLRP3 inhibition. The NLRP3 inflammasome is a key contributor to chronic inflammation linked with aging, cellular stress, and metabolic overload, and plays a central role in promoting the inflammation that characterizes many age-related diseases, including obesity.

Through internal analysis of human aging cohorts, BioAge identified reduced NLRP3 activity as a correlate of increased longevity. In obesity specifically, activation of NLRP3 has been implicated in disrupting appetite regulation via neuroinflammation and exacerbating systemic inflammation, a risk factor for cardiovascular disease.

In preclinical models, BioAge said that BGE-102 has shown the ability to induce significant, dose-dependent weight loss comparable to the GLP-1 receptor agonist semaglutide. The treatment effect, driven primarily by reduced food intake, was maintained across a 28-day dosing period and accompanied by improvements in insulin sensitivity. When used in combination with semaglutide, BGE-102 provided additive benefits, with the combination leading to over 20 percent weight reduction. The results suggest that BGE-102 could serve as both a standalone therapy and a complementary agent to existing GLP-1 based treatments.

“By inhibiting the NLRP3 inflammasome, BGE-102 targets a core pathway that links metabolism, inflammation, and aging,” said BioAge co-founder and CEO Dr Kristen Fortney. “Its potential potency, brain penetration, and pharmacokinetics suggest the possibility for once-daily dosing position BGE-102 as a convenient oral therapy for obesity—either alone or alongside GLP-1 receptor agonists—and may unlock additional opportunities in diseases driven by NLRP3-mediated inflammation.”

Photographs courtesy of BioAge Labs.