ARD-201 / Aardvark Therap - LARVOL DELTA

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 (GlobeNewswire) - "Data in the validated diet-induced obesity (DIO) mouse model (a conventional model recognized for its strong translational relevance in the field of glucagon-like peptide-1 receptor agonists (GLP-1RAs)) demonstrated potential applications for ARD-201, including for the attenuation of weight gain after withdrawal from GLP-1RA therapies, as a monotherapy for weight loss without GLP-1RA therapy, as well as for weight loss in combination with GLP-1RA therapy. Details of the study will be submitted for peer review publication."

Preclinical • Obesity

Driven by these new preclinical insights, Aardvark is advancing ARD-201 into two Phase 2 trials: (GlobeNewswire) - "Phase 2 POWER Trial (Prevention Of WEight Regain): Expected to initiate in 2H 2025, this trial will evaluate ARD-201’s potential to prevent weight regain in subjects who discontinue GLP-1RA therapy after achieving substantial prior weight loss (~15%), reducing the burden of chronic injectable use...Phase 2 STRENGTH Trial (Sitagliptin and TAS2R for weight Reduction with Exercise, Nutrition, and GLP-1RA Trial and Hunger assessment): Planned for initiation in 1H 2026, this trial will explore placebo-adjusted weight loss of ARD-201 alone and the additive effects of ARD-201 combined with GLP-1RA therapy."

New P2 trial • Obesity

Aardvark Therapeutics Reports Full Year 2024 Financial Results and Provides Business Highlights (GlobeNewswire) - "Initiation of the Phase 2 HONOR trial of ARD-101 for the treatment of hyperphagia associated with acquired hypothalamic obesity is expected in the second half of 2025. Initiation of the Phase 2 EMPOWER trial of ARD-201 for the treatment of obesity and obesity-related conditions as a fixed-dose combination of ARD-101 with a dipeptidyl peptidase-4 (DPP-4) inhibitor is expected in the second half of 2025. Topline data from the Phase 3 HERO trial for the treatment of hyperphagia associated with PWS is expected in early 2026."

New P2 trial • P3 data: top line • Obesity • Prader–Willi syndrome