Hengrui's Dual GLP-1/GIP Agonist Shows Promising Results in Phase III Obesity Trial

Hengrui Pharma, in collaboration with Massachusetts-based Kailera Therapeutics, has announced impressive topline results from a Phase III trial of their dual GLP-1/GIP receptor agonist, HRS9531, for the treatment of obesity. The study, conducted in Shanghai, China, demonstrated significant weight loss in patients, positioning the drug as a potential breakthrough in obesity management.

Phase III Trial Results

The trial, involving 567 Chinese patients who are overweight or have obesity, showed that HRS9531 elicited an average weight loss of 17.7% compared to placebo over 48 weeks. The study met its primary endpoint, with the drug demonstrating superior weight loss across three different doses: 2 mg, 4 mg, and 6 mg.

Key findings from the trial include:

• 88% of patients receiving HRS9531 achieved at least 5% weight loss
• 44.4% of participants reached 20% weight loss
• The safety and tolerability profile was consistent with GLP-1 based treatments and previously reported Phase II data

Hong Chen, head of the metabolism department at Hengrui, stated, "This is a huge step forward in providing innovative solutions to meet the needs of people living with obesity."

Next Steps and Global Development

Following these positive results, Hengrui is planning to submit a new drug application for HRS9531 in chronic weight management in China. Meanwhile, Kailera Therapeutics is preparing to conduct global clinical trials, focusing on both higher doses and longer treatment durations.

The collaboration between Hengrui and Kailera represents a novel strategy in drug development. Kailera, which launched in October 2024 with $400 million in financing, acquired global development and commercialization rights for HRS9531 (known as KAI-9531 outside of China) and three other Hengrui molecules for markets outside of greater China.

Expanding Obesity Treatment Portfolio

In addition to HRS9531/KAI-9531, Kailera's portfolio includes several other promising candidates for obesity treatment:

• KAI-4729: An injectable GLP-1/GIP/glucagon receptor triple-agonist
• KAI-7535: A clinical-stage oral small molecule GLP-1 receptor agonist
• An oral formulation of KAI-9531

These developments highlight the growing focus on multi-targeted approaches in obesity treatment, with pharmaceutical companies exploring various combinations of receptor agonists to achieve optimal weight loss outcomes.