Hengrui Pharma has tied its injectable GLP-1/GIP receptor dual agonist to a mean weight loss of almost 18% at 48 weeks, leading the biotech to push for approval in China “as soon as possible.”
The phase 3 trial in China evaluated 2-mg, 4-mg and 6-mg weekly subcutaneous doses of the candidate, dubbed HRS9531, or placebo across 531 adults with obesity or overweight, but without diabetes. Patients achieved a mean weight loss of up to 17.7%—16.3% when adjusted for placebo—rising to 19.2% for the highest, 6-mg, dose in a prespecified supplementary analysis.
The late-stage readout suggests that HRS9531 can hold its own against Eli Lilly’s blockbuster GLP-1/GIP agonist Zepbound, which has been tied to a (PDF) 20.9% reduction in body weight after 36 weeks.
About 88% of patients who received HRS9531 achieved at least 5% weight loss, and 44.4% achieved at least 20% weight loss, according to Hengrui, which said the study hit its primary endpoints.
Most treatment-emergent adverse events were mild to moderate and gastrointestinal-related, the company added.
Hengrui’s candidate posted a more impressive 22.8% mean weight loss at the same 36-week mark in a phase 2 study at the start of the year, although this was at a higher 8-mg dose than was included in the phase 3 trial.
The company's U.S.-based partner Kailera Therapeutics said in this morning's release that the company would investigate the drug’s potential at higher doses in global trials.
“We commend our colleagues at Hengrui for these impressive phase 3 clinical results, building on the strong momentum behind HRS9531 (KAI-9531),” Kailera CEO Ron Renaud said. “As Kailera prepares to advance KAI-9531 into a global clinical program, we look forward to evaluating both higher doses and longer duration of treatment to expand on KAI-9531's best-in-class potential.”
Hengrui, meanwhile, has its sights set on taking HRS953 to regulators in its home territory of China. If successful, the drug would become the latest homegrown drug to enter China’s obesity market, after Innovent’s dual GCG/GLP-1 med mazdutide secured approval last month.
“The positive data from the HRS9531-301 study demonstrated meaningful, sustained weight loss,” Hong Chen, Head of Metabolism Department I of Hengrui, said in this morning’s release.
“With an affirmed safety and tolerability profile, we strongly believe in its potential to help more people living with obesity reach their individual weight loss goals,” they added. “Based on these robust and encouraging clinical results, we are accelerating our efforts to advance this highly promising candidate.”