Aardvark Unveils Promising ARD-201 Data For Obesity And Weight Maintenance

(RTTNews) - Aardvark Therapeutics (AARD) reported positive preclinical results for ARD-201 in a diet-induced obesity (DIO) mouse model, indicating potential as an oral treatment for weight loss and weight maintenance.

The therapy showed promise as a standalone option, in combination with GLP-1 receptor agonists (GLP-1RAs), and for sustaining weight after GLP-1RA withdrawal.

In the study, ARD-201 monotherapy delivered ~19% weight loss in 30 days. In weight maintenance testing after high-dose tirzepatide, ARD-201 alone matched high-dose therapy's effectiveness, while combining ARD-201 with low-dose tirzepatide achieved further weight loss.

Aardvark will launch two Phase 2 studies: the POWER trial (2H 2025) to prevent weight regain post-GLP-1RA discontinuation, and the STRENGTH trial (1H 2026) to assess ARD-201 alone and in combination with GLP-1RAs for weight loss quality and muscle preservation. These replace the previously planned EMPOWER trial.

Executives and independent experts said the data reinforce ARD-201's potential to fill gaps in obesity care by providing an oral, complementary approach that supports long-term results.

ARD-201 combines a DPP-4 inhibitor with ARD-101, a gut-restricted TAS2R agonist that triggers satiety hormones like GLP-1 and CCK, while preventing their breakdown, enhancing fullness and reducing hunger. ARD-101 is also in a Phase 3 trial for hyperphagia in Prader-Willi Syndrome.

Tuesday AARD closed at $10.04, down 9.96%, and is unchanged in after-hours trading on the NasdaqGS.