Jiangsu Hengrui Pharmaceuticals and Kailera Therapeutics have announced positive topline data from the 8mg dose of Hengrui Pharma’s Phase 2 clinical trial (HRS9531-203) of HRS9531, a GLP-1/GIP receptor dual agonist, in individuals living with obesity or overweight. HRS9531 is a novel injectable GLP-1/GIP receptor dual agonist formulated as an injectable peptide in clinical development for the treatment of obesity and type 2 diabetes.
The clinical trial results showed that a once-weekly subcutaneous injection of the 8mg dose of HRS9531 demonstrated a statistically significant 21.1% (p<0.0001) placebo-adjusted mean weight loss (22.8% mean change from baseline) at week 36, with no plateau in weight loss. Additionally, 59% of HRS9531-treated participants achieved a weight loss of ≥20%.
The trial results demonstrated a favourable safety profile. Most adverse events (AEs) were mild and consistent with the profile reported for the injectable GLP-1/GIP receptor dual agonist class. The gastrointestinal-related AEs occurred primarily during dose titration.
“These compelling clinical results give us even greater confidence in the significant impact HRS9531 could have for the treatment of obesity and related conditions,” said Ron Renaud, President & Chief Executive Officer, Kailera Therapeutics. “We are focused on building our clinical and manufacturing teams and infrastructure to advance HRS9531 as KAI-9531 into a global Phase 3 program. With our partner Hengrui, we believe that KAI-9531 is a leading next-generation treatment for chronic weight management with the potential to provide meaningful outcomes for many people.”
These data build on the HRS9531 Phase 2 clinical results (HRS9531-201) - presented in June 2024 at the American Diabetes Association (ADA) Scientific Sessions - that showed HRS9531 was well-tolerated and demonstrated dose-dependent, placebo-adjusted mean weight loss across four doses administered weekly by subcutaneous injection, with maximum placebo-adjusted mean weight loss of 16.7% (p<0.0001) at the 6mg dose at 24 weeks. In both clinical trials, patients receiving 6 mg or 8 mg of HRS9531 benefited from a dose titration schedule that included 12 weeks of treatment at the target dose.
Hengrui intends to share these Phase 2 clinical trial data evaluating the 8mg dose of HRS9531 at an upcoming scientific conference.
The HRS9531-203 clinical trial is a multicentre, randomised, double-blind, placebo-parallel-controlled, Phase 2 trial (NCT06054698) conducted by Hengrui Pharma in China to evaluate the efficacy and safety of the 8 mg dose of HRS9531 injection in adults (ages 18-65) with overweight or obesity (BMI 24-40 kg/m2) without type 2 diabetes. The study enrolled 61 participants with 49 participants receiving HRS9531.
The primary endpoint of the trial is percentage change from baseline in body weight after 36 weeks of treatment. Participants were randomised (4:1) to receive once-weekly subcutaneous injections of HRS9531 or placebo titrating up to the target dose of 8mg over a 24-week period and then maintaining that dose for 12 weeks.
The HRS9531-201 clinical trial was a multi-centre, randomised, double-blind, placebo-parallel controlled Phase 2 clinical study (NCT05881837) conducted by Hengrui Pharma in China to evaluate the efficacy and safety of HRS9531 injection in adults (aged 18-65) with obesity (BMI of 28–40 kg/m2) without type 2 diabetes. The study enrolled 249 participants with 240 completing the 24-week double-blind treatment period.
The primary objective was to evaluate the efficacy and dose-response relationship of HRS9531 injection vs. placebo in reducing body weight after 24 weeks of treatment, with a minimum of 12 weeks at top dose. Participants were randomised (4:1) to receive once-weekly subcutaneous injections of HRS9531 or placebo across four dose cohorts (1.0mg, 3.0mg, 4.5mg and 6.0mg) for 24 weeks.
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