• In Phase 3 trial in obesity/overweight in China, HRS-7535 achieved a mean weight loss of up to 10.9% at Week 44 and a mean weight loss of up to 11.1% at Week 50 
  • Kailera currently conducting global Phase 2 trial of KAI-7535 in obesity to further optimize KAI-7535's clinical profile for the treatment of obesity
  • In second Phase 3 trial in type 2 diabetes in China, HRS-7535 lowered HbA1c by an average of 1.50% to 1.68% across doses
  • Liver safety findings in both Phase 3 trials consistent with data generated to date; no liver safety signals observed


WALTHAM, Mass., July 07, 2026 (GLOBE NEWSWIRE) -- Kailera Therapeutics, Inc. (Kailera), a clinical-stage biotechnology company focused on elevating the next era of obesity care, today announced positive topline data from two additional Phase 3 clinical trials of oral small molecule GLP-1 receptor agonist HRS-7535 (also known as KAI-7535) conducted by Hengrui Pharma: the Phase 3 HARBOR-1 trial (NCT06904105) in adults living with obesity/overweight in China and the Phase 3 OUTSTAND-2 trial (NCT06589765) in adults with type 2 diabetes (T2D) in China.

Kailera is concurrently advancing KAI-7535 in a global Phase 2 clinical trial in people living with obesity or overweight. The trial initiated in April 2026, with data expected in 2027.