BioAge Begins Dosing in Phase 2 Trial of Azelaprag and Tirzepatide for Obesity

BioAge Labs, Inc., a clinical-stage biopharmaceutical company, has announced that it has dosed the first patient in the STRIDES Phase 2 clinical trial. This trial is evaluating the efficacy of BioAge’s lead product candidate, azelaprag, in combination with tirzepatide, for treating obesity in adults aged 55 and older.

Azelaprag is an orally administered small molecule that acts as an agonist of the apelin receptor APJ. Apelin, a molecule induced by exercise, targets the APJ receptor to deliver many of the metabolic benefits associated with physical activity. A Phase 1b clinical trial in older volunteers undergoing 10 days of bed rest showed that azelaprag improved muscle metabolism, reduced muscle atrophy, and maintained levels of resting energy expenditure and cardiorespiratory fitness. Azelaprag has demonstrated good tolerance across more than 240 subjects in seven Phase 1 clinical trials. In mouse models of obesity, azelaprag effectively increased the weight loss achieved with incretin drugs while restoring healthy body composition and physical function.

Kristen Fortney, PhD, CEO and co-founder of BioAge, expressed optimism about combining azelaprag with tirzepatide, a GLP-1/GIP receptor agonist that reduces food intake. “We believe combining azelaprag, an exercise mimetic, with tirzepatide, a GLP-1/GIP receptor agonist that decreases food intake, could provide a powerful pharmacological parallel to the exercise and diet interventions that form the foundation of obesity management,” Fortney stated. She emphasized that the STRIDES trial aims to demonstrate the added benefit of activating apelin signaling with azelaprag in achieving higher weight loss in patients on incretins. Additionally, the trial may highlight the potential for azelaprag to match the efficacy of injectable weight loss drugs when combined with incretins in an all-oral regimen.

The STRIDES trial is a randomized, double-blind, placebo-controlled Phase 2 clinical trial that will involve approximately 220 obese individuals aged 55 years and older. It aims to evaluate the efficacy, safety, and tolerability of two oral doses of azelaprag (300 mg once or twice daily) combined with tirzepatide (5 mg subcutaneous injection once weekly). The primary endpoint is the mean percent change in body weight at 24 weeks. Additional exploratory endpoints include body composition, glycemic control, obesity-related biomarkers, and patient-reported outcomes related to health and quality of life. Top-line results from the trial are expected in the fourth quarter of 2025.

BioAge Labs is conducting the trial in collaboration with Eli Lilly and Company's Chorus clinical development organization, with Lilly providing tirzepatide for the trial.

In addition to the STRIDES trial, BioAge has planned a second Phase 2 clinical trial that will evaluate azelaprag in combination with semaglutide (Wegovy) with an anticipated initiation in the first half of 2025. Together, these trials aim to support BioAge’s goal of developing an all-oral combination product for treating obesity.

BioAge Labs is a clinical-stage biopharmaceutical company focused on developing therapeutic products for metabolic diseases by targeting the biological processes of human aging. Their lead product candidate, azelaprag, has shown promise in promoting metabolism and preventing muscle atrophy. The company is also working on orally available small molecule brain-penetrant NLRP3 inhibitors for treating neuroinflammatory diseases. BioAge’s research is based on novel insights from their discovery platform, which utilizes human longevity data to explore key pathways in metabolic aging.