Aardvark Therapeutics Announces ARD-201 Preclinical Obesity Data Showing Significant Weight Loss as a Monotherapy, Enhancement of GLP-1RA Therapy in Combination, and Effective Maintenance Following Discontinuation of GLP-1RA Therapy

Core Insights - Aardvark Therapeutics announced positive preclinical data for ARD-201, indicating its potential for treating metabolic obesity and related conditions, particularly in weight maintenance after GLP-1RA therapy withdrawal [1][5][7] Company Overview - Aardvark Therapeutics is a clinical-stage biopharmaceutical company focused on developing small-molecule therapeutics aimed at treating metabolic diseases and hunger-related conditions [9] - The lead compound, ARD-101, is in Phase 3 clinical development for hyperphagia associated with Prader-Willi Syndrome, while ARD-201 is a fixed-dose combination of ARD-101 and a DPP-4 inhibitor [9] Preclinical Study Findings - In a validated diet-induced obesity mouse model, ARD-201 demonstrated a significant weight loss of approximately 19% after 30 days of treatment [2][5] - ARD-201 showed improved weight maintenance compared to negative controls and similar results to high-dose tirzepatide, a benchmark GLP-1RA therapy [2][5] - The combination of ARD-201 with low-dose tirzepatide resulted in continued weight loss compared to high-dose tirzepatide alone [5] Future Clinical Trials - Aardvark plans to initiate two Phase 2 clinical trials: the POWER trial focusing on weight rebound prevention after GLP-1RA therapy discontinuation, and the STRENGTH trial assessing weight loss as a monotherapy and in combination with GLP-1RA [6][10] - The POWER trial is expected to start in the second half of 2025, while the STRENGTH trial is planned for the first half of 2026 [10] Mechanism of Action - ARD-201 combines a DPP-4 inhibitor with ARD-101, targeting taste receptors in the gut to enhance satiety and reduce hunger by stimulating the release of signaling molecules like GLP-1 [7][9]