Kailera Therapeutics Reports Positive Phase 3 Results for HRS-7535
Kailera Therapeutics announced positive topline results from two Phase 3 clinical trials conducted by its partner, Hengrui Pharma, evaluating the oral small molecule candidate HRS-7535, also known as KAI-7535. In the HARBOR-1 trial for obesity, the candidate achieved a mean weight loss of up to 10.9% at week 44 and 11.1% at week 50. In the OUTSTAND-2 trial for type 2 diabetes, the once-daily drug met its primary endpoint of non-inferiority to dapagliflozin, reducing blood sugar levels by up to 1.68% at week 32. Kailera is concurrently evaluating KAI-7535 in an ongoing global Phase 2 trial for obesity, with results expected in 2027. "The HRS-7535 Phase 3 results highlight the promise of oral small molecules as a treatment option for people living with obesity, with the potential to combine clinically meaningful weight loss with convenience, scalability, and accessibility," said Scott Wasserman, chief medical officer, Kailera.
