Aardvark Therapeutics announced on Mar. 24 that it has paused two mid-stage clinical trials for its obesity drug ARD-201 following the detection of cardiac safety signals in patients. The company said the decision affects both the Phase 2 POWER trial, which tests ARD-201's ability to maintain weight loss in patients who have lost significant weight on GLP-1 therapies, and the Phase 2 STRENGTH study, which combines ARD-201 with an unspecified GLP-1 drug.
The suspension comes as Aardvark continues to investigate heart-related observations seen in previous studies of its lead compound. The company did not specify when these trials might resume but stated it would provide further guidance during the second quarter.
Analysts at William Blair acknowledged risks associated with Aardvark’s programs, referencing both the obesity studies and a recently suspended trial of ARD-101 for Prader-Willi syndrome. "We acknowledge the risks associated with Aardvark’s current programs," William Blair analysts told investors. Despite these setbacks, they said Aardvark remains “an intriguing investment opportunity” due to its current trading value.
ARD-201 is based on ARD-101 and works by targeting taste receptors in the intestine to increase satiety hormones such as GLP-1. It also includes a dipeptidyl peptidase-4 inhibitor to extend gut hormone activity. In late February, Aardvark detected heart signals in healthy volunteers given higher-than-recommended doses of ARD-101; although described as reversible events, this led to a halt in enrollment and dosing for another study out of caution.
On Monday, Aardvark revealed more details about these cardiac findings: two patients showed echocardiographic anomalies suggesting reduced heart efficiency while taking high doses of ARD-101 without prior dose escalation—twice what was planned for other studies. These safety assessments are ongoing as part of routine requirements ahead of a planned approval application.
Aardvark is working with the Food and Drug Administration regarding next steps for ARD-101 and plans to provide updates later this year.
