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 encouraging topline results from a Phase III clinical trial of their dual GLP-1/GIP receptor agonist, HRS9531, for the treatment of obesity and overweight in Chinese patients.

Significant Weight Loss Achieved

The late-stage study, conducted in Shanghai with 567 participants, demonstrated that HRS9531 elicited an average weight loss of 17.7% compared to placebo over 48 weeks. The trial met its primary endpoint, showing superior weight loss across three different doses (2 mg, 4 mg, and 6 mg) in comparison to placebo.

Key findings from the study include:

• 88% of patients receiving HRS9531 achieved at least 5% weight loss
• 44.4% of participants experienced 20% or greater 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."

Regulatory and Global Development Plans

Following these positive results, Hengrui is accelerating its efforts to advance HRS9531. The company plans to submit a new drug application for chronic weight management in China. Meanwhile, Kailera Therapeutics is preparing to conduct global clinical trials to study both higher doses and longer treatment durations.

Full data from the Phase III trial will be presented at an upcoming scientific meeting, providing the medical community with a more comprehensive understanding of the drug's efficacy and safety profile.

Kailera Therapeutics: A Novel Approach to Drug Development

This successful Phase III readout marks a significant milestone for Kailera Therapeutics, which launched in October 2024 with $400 million in financing. The company's innovative strategy involves acquiring global development and commercialization rights for promising molecules from Hengrui, focusing on markets outside of greater China.

In addition to HRS9531 (known as KAI-9531 outside China), Kailera's portfolio includes:

• 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

All of these compounds are being developed to address the growing global obesity epidemic, showcasing the company's commitment to innovative approaches in metabolic disease treatment.