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Hengrui and Kailera Present Phase 2 Data for Dual GLP-1/GIP Agonist and Oral GLP-1 Therapies at ADA 2025

2 months ago3 min read

Key Insights

  • Jiangsu Hengrui Pharmaceuticals and Kailera Therapeutics will present six abstracts at the American Diabetes Association 85th Scientific Sessions showcasing clinical progress of their metabolic disease portfolio.

  • The presentations include Phase 2 data for injectable dual GLP-1/GIP receptor agonist HRS9531 (KAI-9531) in type 2 diabetes and obesity, with trials extending up to 52 weeks.

  • Clinical results will also cover oral small molecule GLP-1 receptor agonist HRS-7535 (KAI-7535) and an oral formulation of the dual agonist HRS9531.

Jiangsu Hengrui Pharmaceuticals and Kailera Therapeutics announced they will present six clinical abstracts at the 85th Scientific Sessions of the American Diabetes Association (ADA), taking place June 20-23, 2025, in Chicago. The presentations will showcase the breadth of their metabolic disease portfolio, featuring data from several clinical-stage injectable and oral therapies targeting type 2 diabetes and obesity.

Phase 2 Results for Dual GLP-1/GIP Receptor Agonist

The companies' most advanced program, HRS9531 (developed as KAI-9531 outside of Greater China), will be featured in multiple presentations. This injectable GLP-1/GIP receptor dual agonist has demonstrated positive results in Phase 2 trials in obesity and type 2 diabetes in China.
A key oral presentation scheduled for Friday, June 20, at 5:45-6:00 p.m. CT will detail the Phase 2 clinical trial of HRS9531 in participants with type 2 diabetes up to 32 weeks. The abstract, titled "Efficacy and Safety of a Novel Dual GLP-1/GIP Receptor Agonist in Participants with Type 2 Diabetes Mellitus Up to 32 Weeks," represents one of the most comprehensive datasets for the compound.
Additional poster presentations will cover extended treatment periods, including a Phase 2 clinical trial of HRS9531 in adults with obesity without diabetes up to 52 weeks. Another poster will present data on a high-dose (8 mg) formulation of HRS9531 in Chinese overweight or obese adults without diabetes.

Oral Formulation Development

The companies are also advancing an oral formulation of HRS9531, with Phase 1 data to be presented on the safety, tolerability, pharmacokinetics, and pharmacodynamics of HRS9531 tablet in healthy participants. This oral peptide approach represents a significant advancement in delivery mechanisms for dual receptor agonists.

Oral Small Molecule GLP-1 Receptor Agonist

The portfolio includes HRS-7535 (KAI-7535), an oral small molecule GLP-1 receptor agonist. Two poster presentations will detail Phase 2 clinical trial results for HRS-7535 in adults with type 2 diabetes inadequately controlled by metformin, as well as efficacy and safety data in Chinese obese adults without diabetes.

Company Portfolios and Development Strategy

Hengrui Pharma operates with a global R&D team that includes 14 R&D centers and more than 5,500 professionals. The company's therapeutic areas of focus include oncology, metabolic and cardiovascular diseases, immunological and respiratory diseases, and neuroscience. To date, Hengrui has commercialized 23 new molecular entity drugs and 4 other innovative drugs in China.
Kailera Therapeutics is developing a broad, advanced, and differentiated portfolio of clinical-stage injectable and oral therapies for the treatment of obesity and related conditions. The company is advancing a diversified pipeline leveraging several mechanisms and routes of delivery, including oral administration, with a mission to develop next-generation weight management therapies.
All abstracts will be published online in the journal Diabetes® and presentations will be accessible on the Scientific Publications section of the Kailera website following the congress.
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