Jiangsu Hengrui Pharmaceuticals and Kailera Therapeutics have announced positive topline data from a Phase 2 clinical trial of HRS9531, a GLP-1/GIP receptor dual agonist, for the treatment of obesity and overweight. The trial, conducted by Hengrui Pharma in China, evaluated the efficacy and safety of an 8 mg dose of HRS9531 in adults without type 2 diabetes.
The results of the HRS9531-203 trial (NCT06054698) demonstrated that a once-weekly subcutaneous injection of the 8 mg dose of HRS9531 led to a statistically significant 21.1% (p<0.0001) placebo-adjusted mean weight loss at week 36. This translated to a 22.8% mean change from baseline, with no plateau observed in weight loss. Furthermore, 59% of participants treated with HRS9531 achieved a weight loss of 20% or more.
Safety and Tolerability
The trial also revealed a favorable safety profile for HRS9531, with most adverse events (AEs) being mild and consistent with those reported for the injectable GLP-1/GIP receptor dual agonist class. Gastrointestinal-related AEs were primarily observed during dose titration.
Future Development
"These compelling clinical results give us even greater confidence in the significant impact HRS9531 could have for the treatment of obesity and related conditions," said Ron Renaud, President & Chief Executive Officer, Kailera Therapeutics. Kailera is focused on advancing HRS9531, known as KAI-9531 outside of Greater China, into a global Phase 3 program. Hengrui Pharma is also conducting Phase 3 clinical trials of HRS9531 in obesity and type 2 diabetes within China.
Trial Design
The HRS9531-203 trial was a multicenter, randomized, double-blind, placebo-parallel-controlled Phase 2 study. It enrolled 61 participants aged 18-65 with overweight or obesity (BMI 24-40 kg/m2) but without type 2 diabetes. Participants were randomized (4:1) to receive once-weekly subcutaneous injections of HRS9531 or placebo, with doses titrated up to the target of 8 mg over 24 weeks, followed by a 12-week maintenance period. The primary endpoint was the percentage change from baseline in body weight after 36 weeks of treatment.
HRS9531 Background
HRS9531 is a novel injectable GLP-1/GIP receptor dual agonist in clinical development for treating obesity and type 2 diabetes. To date, over 650 patients have been dosed with HRS9531 across multiple Phase 1 and Phase 2 clinical trials in China. Kailera Therapeutics is developing HRS9531 globally (excluding Greater China) as KAI-9531.
