STRIDES Halts Azelaprag Obesity Study

No transaminase elevations were observed in the tirzepatide only treatment group.

“Patient safety is our top priority in the conduct of our clinical studies,” said Kristen Fortney, PhD, CEO and co-founder of BioAge. “We made the difficult decision to discontinue the STRIDES Phase II study of azelaprag because it became clear that the emerging safety profile of the current doses tested is not consistent with our goal of a best-in-class oral obesity therapy. While this outcome is a significant disappointment, we remain encouraged by azelaprag’s promising preclinical and Ph1b efficacy profile. We remain committed to our focus on developing therapies for metabolic aging. In parallel to assessing the next steps for the azelaprag program, we will continue to advance our NLRP3 inhibitor program as well as additional research programs with novel mechanisms emerging from our platform.”

STRIDES is a randomized, double-blind, placebo-controlled Phase II clinical trial of azelaprag as monotherapy and in combination with tirzepatide that planned to enroll approximately 220 individuals with obesity aged 55 years and older . The trial was designed to evaluate the efficacy as measured by body weight reduction and other outcomes, safety, and tolerability of two oral doses of azelaprag (300 mg, once or twice daily) in combination with tirzepatide (5 mg subcutaneous injection once weekly). An azelaprag monotherapy arm was included to provide additional safety information.

Of 204 subjects enrolled in STRIDES , 11 subjects in the azelaprag treatment groups were observed to have transaminase elevations with no clinically significant symptoms. Dosing of all subjects will be discontinued, and no additional subjects will be enrolled. Clinical follow-up of enrolled subjects will continue off drug. The Company intends to further analyze available STRIDES clinical data from all enrolled subjects. The Company has notified all study investigators and regulatory authorities including the FDA  of the Company’s decision to discontinue enrollment.   The Company intends to share updated plans for azelaprag in Q1 2025.

BioAge continues to advance its pipeline of therapeutic candidates targeting the biology of aging to treat metabolic diseases. The Company's novel class of brain-penetrant NLRP3 inhibitors, which have demonstrated high potency and a novel binding site, are progressing toward IND submission, anticipated in the second half of 2025. The NLRP3 inhibitor program targets neuroinflammation, which is linked to both metabolic and neurodegenerative diseases. In addition, BioAge is advancing multiple targets derived from its proprietary discovery platform, which analyzes molecular data spanning over 50 years of human aging trajectories.