Jiangsu Hengrui Pharmaceuticals and Kailera Therapeutics have reported positive topline data from Hengrui’s Phase II obesity trial, considering an 8mg dose of the companies’ GLP-1/GIP receptor dual agonist HRS9531.
The multi-centre, randomised, double-blind, placebo-parallel-controlled, Phase II trial (NCT06054698) took place in China. It included 61 patients randomised in a 4:1 ratio, amounting to 49 patients receiving HRS9531. Doses were administered subcutaneously once a week and were titrated up to the target 8mg over a 24-week period. The 8mg dose was then maintained for 12 weeks.
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Results met the primary endpoint: percentage change from baseline in body weight after 36 weeks of treatment. Patients receiving HRS9531 demonstrated a statistically significant 22.8% mean change from baseline (21.1% placebo adjusted) at week 36, with no plateau observed in weight loss.
This could position the candidate as the best in class for subcutaneous obesity treatments, offering results above the approximate 21% change shown by Eli Lilly’s triple agonist, retatrutide.
The study also showed that 59% of patients who received HRS9531 achieved a weight loss of 20% or more.
Hengrui and Kailera reported that HRS9531 demonstrated a favourable safety profile, noting that most adverse events (AEs) were mild and consistent with the profile reported for the injectable GLP-1/GIP receptor dual agonist class. Most gastrointestinal-related AEs occurred during dose titration.
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By GlobalDataRon Renaud, president and CEO at Kailera Therapeutics, commented: “These compelling clinical results give us even greater confidence in the significant impact HRS9531 could have for the treatment of obesity and related conditions.”
“We are focused on building our clinical and manufacturing teams and infrastructure to advance HRS9531 as KAI-9531 into a global Phase III programme. 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.”
Hengrui’s most recent data builds on Phase II clinical results presented in June 2024 at the American Diabetes Association (ADA) Scientific Sessions. These demonstrated that HRS9531 was well tolerated across four doses, with a maximum placebo-adjusted mean weight loss of 16.7% at the 6mg dose at 24 weeks.
Hengrui has ongoing Phase III clinical trials for its GLP-1/GIP product in China, including in the oral space, examining the use of HRS9531 in the treatment of obesity and type 2 diabetes.
GlobalData recently reported that the GLP-1R market experienced significant growth in 2023, generating $37.2bn in sales, led by industry giants Novo Nordisk and Eli Lilly. However, analysts expect the picture is set to shift over the next decade, pointing to the 323 active GLP-1Rs currently in the pipeline.
It expects several newer players to successfully position themselves to enter the obesity treatment market, noting that, while Novo Nordisk and Eli Lilly still dominate, the scene could look vastly different by the end of the decade.
Considering which companies could be ones to watch, Jasper Morley, pharma analyst at GlobalData, said: “Based on their market capitalisation, Viking Therapeutics ($5.2bn), Structure Therapeutics ($1.8bn) and Altimmune ($642m) are small-cap to mid-cap companies that are significantly dwarfed by Eli Lilly and Novo Nordisk. All three US-based companies have no approved products to date. However, by 2030, GlobalData forecasts them to be ranked among the top ten companies by GLP-1R sales.”
GlobalData is the parent company of Clinical Trials Arena.
