Hengrui Pharma and Kailera Therapeutics have reported positive topline data from the former’s Phase III trial (HRS9531-301) of subcutaneous injections of HRS9531 once per week in those with obesity or who are overweight in China.
The HRS9531-301 study targeted adults with obesity or who were overweight and had a minimum of one weight-related comorbidity, excluding those with diabetes.
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Subjects were randomly assigned and given HRS9531 at doses of 2mg, 4mg, 6mg, or a placebo for a 48-week period. Out of the 567 enrolees, 531 completed the study.
The double-blind, randomised, placebo-controlled multi-centre trial has met its primary endpoints.
Participants who received the dual glucagon-like peptide-1/glucose-dependent insulinotropic polypeptide (GLP-1/GIP) receptor agonist, HRS9531, at these doses experienced significantly more weight loss than those who took a placebo during the 48-week timeframe.
The 567 individuals in the trial had a mean baseline body weight of 93kg. The primary analysis showed that those treated with HRS9531 achieved a mean weight loss of up to 17.7%, with the placebo-adjusted figure being 16.3%.
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By GlobalDataIn addition, the trial showed that up to 88% of those treated with HRS9531 lost at least 5% of their body weight, and 44.4% achieved a weight reduction of at least 20%.
A pre-specified supplementary analysis showed a mean weight loss of up to 19.2%, with a placebo-adjusted figure of 17.7%.
The safety profile of HRS9531 was favourable, aligning with GLP-1-based therapies and consistent with previous Phase II clinical data.
Hengrui is now preparing to submit a new drug application in China for chronic weight management while Kailera is set to expand the therapy, as KAI-9531, into worldwide trials.
Kailera Therapeutics CEO and president Ron Renaud said: “We commend our colleagues at Hengrui for these impressive Phase III clinical results, building on the strong momentum behind HRS9531 (KAI-9531).
“As Kailera prepares to advance KAI-9531 into a global clinical programme, we look forward to evaluating both higher doses and longer duration of treatment to expand on KAI-9531’s best-in-class potential.”
HRS9531 is under development to treat type 2 diabetes and conditions related to obesity.
Earlier this year, both companies reported encouraging topline data from a Phase II obesity trial involving an 8mg dose of HRS9531.
