Hengrui Pharma and Kailera Therapeutics Announce Additional Data from Phase 3 Obesity Trial in China of Dual Glp-1/Gip Receptor Agonist Hrs9531

Hengrui Pharma (Hengrui) and Kailera Therapeutics, Inc. (Kailera) announced the presentation of additional data from Hengrui's Phase 3 clinical trial1 (GEMINI-1) of a once-weekly subcutaneous injection of HRS9531, a novel dual GLP-1/GIP receptor agonist, in individuals living with obesity or overweight in China (NCT06396429) at ObesityWeek®? 2025, the annual meeting of The Obesity Society (TOS). The trial met both co-primary endpoints, including superior weight loss with HRS9531 (2 mg, 4 mg, and 6 mg) and greater percentage of participants achieving body weight reductions of at least 5% compared to placebo at 48 weeks.

Hengrui submitted a marketing authorization application to the National Medical Products Administration (NMPA) in China for chronic weight management of HRS9531 in adults, which has recently been accepted. Kailera plans to begin global Phase 3 trials of HRS9531 as KAI-9531 evaluating multiple doses, including 8 mg and 10 mg, and longer treatment durations by year-end 2025. Treatment with HRS9531 resulted in robust improvement in cardiometabolic risk factors including blood pressure, lipids, measures of insulin resistance and hsCRP (high sensitivity C reactive protein).

Safety and Tolerability Summary: The trial results demonstrated a safety and tolerability profile consistent with GLP-1-based treatments and the previously reported HRS9531 Phase 2 clinical data. Most treatment-emergent adverse events (TEAEs) were mild to moderate and were gastrointestinal-related. Permanent treatment discontinuation rates due to TEAEs were very low with 0.7% (1 participant, 2 mg), 0.7% (1 participants, 4 mg), 1.4% (2 participants, 6 mg) and 0% (placebo).

In previously reported Phase 2 clinical trial2 (NCT06054698) results evaluating the 8 mg dose of HRS9531, participants taking HRS9531 achieved a mean weight loss of 23.6% (21.7% placebo-adjusted)I at week 36, with no plateau in weight loss and a favorable safety profile consistent with otherGLP-1-based treatments. Kailera's global Phase 3 program is evaluating multiple maintenance doses, including 8 mg and10 mg, and at least 52 weeks of maintenance dosing. The company plans to initiate this program by year-end 2025.