Obesity in adults aged 55 and older is the focus of BioAge Labs’s STRIDES Phase 2 clinical trial, where the first patient has been dosed to evaluate BioAge’s lead product candidate azelaprag in combination with tirzepatide. Azelaprag is an orally available small molecule agonist of the apelin receptor APJ. Apelin is an exercise-induced signaling molecule (exerkine) that acts on APJ to mediate many of the metabolic benefits of physical activity.
In a Phase 1b clinical trial in healthy older volunteers on 10 days of bed rest, azelaprag was observed to improve muscle metabolism, decrease muscle atrophy, and preserve measures of resting energy expenditure and cardiorespiratory fitness. Azelaprag has been well tolerated in more than 240 subjects across seven Phase 1 clinical trials to date. In mouse models of obesity, the addition of azelaprag approximately doubled the weight loss achieved with incretin drugs (GLP-1 receptor agonists) while restoring healthy body composition and physical function.
Combining Azelaprag and Tirzepatide Shows Promise for Obesity Management in STRIDES Trial
“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,” said Kristen Fortney, PhD, CEO and co-founder of BioAge. “The STRIDES trial aims to demonstrate that activating apelin signaling with azelaprag is a potent complementary mechanism that can deliver increased weight loss efficacy in patients on incretins. In addition, this trial will provide a direct read-through to azelaprag’s potential as an orally available small molecule to achieve efficacy on par with injectable weight loss drugs when combined with incretins in an all-oral regimen.”
STRIDES is a randomized, double-blind, placebo-controlled Phase 2 clinical trial of azelaprag in combination with tirzepatide that will enroll approximately 220 obese individuals aged 55 years and older. The trial will evaluate the efficacy, 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). The primary endpoint is 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 are anticipated in the fourth quarter of 2025.
STRIDES is being conducted in collaboration with Eli Lilly and Company’s (Lilly) Chorus clinical development organization. Lilly is providing tirzepatide for the trial. A second planned Phase 2 clinical trial will assess azelaprag in combination with semaglutide (Wegovy®) with initiation expected in the first half of 2025. Together, the trials will seek to support BioAge’s therapeutic goal of developing an all-oral combination product for obesity. This comprehensive approach aims to provide an effective and convenient treatment option for patients struggling with obesity, particularly those who may benefit from a non-surgical, pharmacological solution.
Advancing Obesity Treatment: BioAge Explores Synergistic Potential of Azelaprag and Tirzepatide
By exploring the synergistic potential of azelaprag and tirzepatide, BioAge aims to advance the field of obesity treatment. The STRIDES trial represents a significant step towards addressing the complex challenge of obesity, which affects millions of individuals worldwide. With the ultimate goal of improving patient outcomes and quality of life, BioAge is committed to developing innovative therapies that harness the latest scientific insights into human aging and metabolic health.
As the trial progresses, BioAge anticipates gathering valuable data that will inform future research and development efforts. The company’s collaboration with Eli Lilly and other partners underscores the importance of strategic alliances in accelerating the development of groundbreaking treatments. The results of the STRIDES trial and the subsequent Phase 2 study with semaglutide will be closely watched by the medical community, patients, and stakeholders eager for new advancements in the fight against obesity.
In summary, BioAge’s STRIDES Phase 2 clinical trial is poised to explore the combined effects of azelaprag and tirzepatide in treating obesity, offering hope for a more effective and accessible therapeutic option for individuals battling this chronic condition. The success of this trial could pave the way for further innovations in obesity management, contributing to better health outcomes for patients worldwide.
Resource: Business Wire, July 29, 2024
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