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

Hengrui Pharma has reported impressive results from a Phase III trial of its dual GLP-1/GIP receptor agonist, HRS9531, 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, involving 567 Chinese patients who were overweight or obese, showed that HRS9531 achieved a mean weight loss of up to 17.7% after 48 weeks of treatment. When adjusted for placebo, this figure stood at 16.3%. Notably, the highest dose of 6 mg resulted in a 19.2% weight reduction in a prespecified supplementary analysis.

The drug's efficacy was further underscored by the fact that 88% of patients receiving HRS9531 achieved at least 5% weight loss, while 44.4% reached or exceeded 20% weight loss. These results indicate that HRS9531 could potentially rival Eli Lilly's Zepbound, which has been associated with a 20.9% reduction in body weight after 36 weeks.

Safety Profile and Dosing

The safety and tolerability of HRS9531 were reported to be consistent with other GLP-1 based treatments. Most treatment-emergent adverse events were described as mild to moderate and primarily gastrointestinal-related. The trial evaluated weekly subcutaneous doses of 2 mg, 4 mg, and 6 mg, with the 6 mg dose showing the most pronounced effects.

Strategic Implications and Future Plans

Hengrui Pharma is now preparing to submit a new drug application for HRS9531 in China for chronic weight management. This move could potentially introduce a new homegrown drug to China's obesity market, following the recent approval of Innovent's dual GCG/GLP-1 medication, mazdutide.

Simultaneously, Kailera Therapeutics, Hengrui's U.S.-based partner, is planning to conduct global clinical trials to investigate higher doses and longer treatment durations of the drug, known as KAI-9531 outside of China. This collaborative effort aims to expand on the drug's potential and explore its efficacy in diverse patient populations.

Hong Chen, Head of the Metabolism Department at Hengrui, expressed optimism about the drug's potential, stating, "This is a huge step forward in providing innovative solutions to meet the needs of people living with obesity." The company plans to present the full data from the Phase III trial at an upcoming scientific meeting, which will likely provide more detailed insights into the drug's performance across different patient subgroups and dosage levels.