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

Hengrui Pharma has reported impressive results from its Phase III clinical trial of HRS9531, a dual GLP-1/GIP receptor agonist for the treatment of obesity. The study, conducted in China, demonstrated significant weight loss in patients, positioning the drug as a potential competitor to established obesity treatments.

Trial Results and Clinical Efficacy

The Phase III trial, which included 567 Chinese patients who were overweight or obese, showed that HRS9531 elicited an average weight loss of 17.7% compared to placebo over 48 weeks. The study evaluated three different doses: 2 mg, 4 mg, and 6 mg, administered weekly via subcutaneous injection.

Key findings from the trial include:

• 88% of patients receiving HRS9531 achieved at least 5% weight loss
• 44.4% of participants reached at least 20% weight loss
• The highest dose (6 mg) resulted in a 19.2% mean weight loss in a prespecified supplementary analysis
• The placebo-adjusted weight loss was 16.3%

These results suggest that HRS9531 may be competitive with other obesity treatments on the market, such as Eli Lilly's Zepbound, which has shown a 20.9% reduction in body weight after 36 weeks in previous studies.

Safety Profile and Next Steps

The safety and tolerability of HRS9531 were reported to be consistent with other GLP-1 based treatments. Most treatment-emergent adverse events were mild to moderate and primarily gastrointestinal-related, aligning with the drug's mechanism of action.

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." The company is now accelerating efforts to advance the candidate and plans to submit a new drug application for chronic weight management in China.

Global Development and Partnerships

HRS9531 is being developed in collaboration with Massachusetts-based Kailera Therapeutics, which holds global development and commercialization rights outside of greater China. Kailera, which launched in October 2024 with $400 million in financing, plans to conduct global clinical trials to study both higher doses and longer treatment durations.

Ron Renaud, CEO of Kailera, commented on the results, saying, "We commend our colleagues at Hengrui for these impressive Phase 3 clinical results, building on the strong momentum behind HRS9531 (KAI-9531)." Kailera aims to expand on the drug's potential best-in-class status through its global clinical program.

The positive outcome of this trial marks a significant development in the obesity treatment landscape, particularly for the Chinese market. As Hengrui prepares for regulatory submission in China and Kailera advances global trials, HRS9531 could become a major player in the growing field of GLP-1/GIP receptor agonists for weight management.