AI Biotech BioAge Initiates STRIDES Phase 2 Clinical Trial for Obesity Treatment
BioAge Labs, Inc. has announced the dosing of the first patient in the STRIDES Phase 2 clinical trial. This study aims to evaluate the efficacy of azelaprag, an oral small molecule apelin receptor agonist, combined with tirzepatide for treating obesity in adults aged 55 and older.
Conducted in collaboration with Eli Lilly and Company’s Chorus clinical development organization, the trial will assess weight loss, safety, and tolerability over 24 weeks.
BioAge Labs, based in Richmond, California, is a clinical-stage biotechnology company dedicated to developing therapeutics targeting the molecular causes of aging to extend healthy human lifespan. Their proprietary platform integrates extensive omics data and machine learning to identify and exploit key longevity pathways. BioAge focuses on creating treatments for metabolic diseases such as obesity and neuroinflammation, with lead candidates including azelaprag for obesity and NLRP3 inhibitors for neuroinflammatory conditions
Azelaprag functions by mimicking the biological effects of exercise. As an agonist of the apelin receptor APJ, it triggers metabolic benefits typically induced by physical activity. Previous studies have shown that azelaprag can improve muscle metabolism, reduce muscle atrophy, and maintain energy expenditure and cardiorespiratory fitness during periods of inactivity. Additionally, in preclinical models, azelaprag enhanced weight loss achieved with incretin drugs and improved body composition and physical function.
Kristen Fortney, PhD, CEO and co-founder of BioAge, emphasized the potential of combining azelaprag with tirzepatide, a GLP-1/GIP receptor agonist that reduces food intake. She noted that this combination could offer a pharmacological parallel to exercise and diet interventions, enhancing weight loss outcomes for patients on incretin therapies.
The STRIDES trial is a randomized, double-blind, placebo-controlled study involving approximately 220 obese individuals aged 55 and older. Participants will receive either a placebo or one of two doses of azelaprag (300 mg once or twice daily) alongside tirzepatide (5 mg weekly subcutaneous injection). The primary endpoint is the mean percent change in body weight at 24 weeks, with secondary exploratory endpoints including body composition, glycemic control, obesity-related biomarkers, and patient-reported health and quality of life outcomes. Results are expected in the fourth quarter of 2025.
Looking ahead, BioAge plans a second Phase 2 clinical trial to investigate azelaprag in combination with semaglutide (Wegovy®), with an anticipated start in early 2025. These trials aim to support the development of an all-oral combination therapy for obesity.
Topics: Clinical Trials
