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BioAge Labs has made headlines with its decision to halt a Phase 2 clinical trial of azelaprag, an experimental obesity drug, due to safety concerns. The trial, called STRIDES, combined azelaprag with Eli Lilly’s popular drug tirzepatide (marketed as Zepbound). Researchers observed elevated liver enzyme levels—an indicator of potential organ damage—in participants who received azelaprag, either alone or in combination with Zepbound. In contrast, those treated with Zepbound alone showed no such issues. Despite the lack of noticeable symptoms linked to the enzyme spikes, the company decided to discontinue the trial and pause enrollment, leading to a dramatic 75% drop in its share price.
Azelaprag is based on apelin, a peptide released during exercise, and was designed to complement incretin drugs like tirzepatide by promoting weight loss while preserving muscle mass. Launched in July 2024, the trial aimed to test this approach in 220 participants over 55 with obesity. While early preclinical data seemed promising, BioAge’s CEO, Kristen Fortney, acknowledged the safety concerns made it clear that the doses tested did not align with their goal of developing a best-in-class obesity treatment.
The decision represents a setback for BioAge, which had raised significant capital earlier this year to fund its expansion into metabolic therapies after pivoting from age-related disease treatments. The company had ambitious plans for azelaprag, including a future trial with semaglutide (Novo Nordisk’s Wegovy) to compete in a growing market of weight loss drugs that aim to preserve lean muscle. While BioAge regroups, it plans to focus on advancing its pipeline, including programs targeting the central nervous system, with updates expected in late 2025.
