BioAge Labs has initiated a Phase 2 clinical trial, STRIDES, to assess the efficacy of azelaprag, a small molecule that mimics the effects of exercise in combination with tirzepatide for treating obesity in individuals aged 55 and above.
Azelaprag, an apelin receptor agonist, is designed to activate signaling pathways that promote metabolic benefits similar to physical activity. Preclinical studies have shown that azelaprag enhances muscle metabolism, reduces muscle loss, and maintains cardiorespiratory fitness.
The STRIDES trial aims to evaluate the weight loss potential of azelaprag when combined with tirzepatide, a GLP-1/GIP receptor agonist that suppresses appetite. The trial will enroll approximately 220 obese individuals and measure the efficacy, safety, and tolerability of azelaprag at two oral doses in combination with tirzepatide.
The primary endpoint is the mean percentage change in body weight at 24 weeks. Exploratory endpoints include body composition, blood sugar control, and patient-reported outcomes related to health and quality of life. Top-line results are expected in the fourth quarter of 2025.
The trial is being conducted in collaboration with Lilly’s Chorus clinical development organization, which provides tirzepatide. A second Phase 2 trial is planned to assess the combination of azelaprag with semaglutide.
These trials aim to demonstrate the potential of azelaprag as an orally administered small molecule that can enhance the weight loss efficacy of incretin drugs, offering a potential alternative to injectable treatments.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
