Hengrui Pharma Announces Positive Topline Results from China Phase 3 Type 2 Diabetes Study (OUTSTAND-1) of Oral Small-Molecule GLP-1 Receptor Agonist HRS-7535
On May 27, 2026, Hengrui Pharma and Kailera Therapeutics, Inc. (Kailera) jointly announce positive topline results from the Phase 3 clinical trial (OUTSTAND-1) of the oral small-molecule GLP-1 receptor agonist HRS-7535 (known as KAI-7535 outside Greater China) in 284 adult patients with type 2 diabetes in China. At 32 weeks, primary endpoint data show that the three dose groups (30 mg, 60 mg, 90 mg) of HRS-7535 achieve HbA1c reductions of 1.40%–1.68%<sup>i</sup>; the key secondary endpoint, the proportion of patients achieving HbA1c <7.0%, reaches 83.5%–89.6%.
Hengrui Pharma plans to submit a new drug application for HRS-7535 for the treatment of type 2 diabetes in China. Meanwhile, the Phase 3 trial (HARBOR-1) of the same product for overweight or obesity indications is ongoing in China, with data to be disclosed in 2026. Kailera is currently conducting a global Phase 2 clinical trial of KAI-7535 for obesity.
HRS-7535 demonstrates a favorable safety and tolerability profile. Most treatment-emergent adverse events are mild to moderate, primarily gastrointestinal adverse events. No grade 3 hypoglycemic events are reported. No liver safety signals are observed. Consistent with the known safety profile of GLP-1 receptor agonists, no new risk signals are identified.
Hengrui Pharma plans to share key data from the OUTSTAND-1 clinical trial at an upcoming scientific conference. Leveraging its forward-looking strategy in the metabolic disease area, Hengrui Pharma has built a leading and differentiated GLP-1 asset portfolio and a robust next-generation innovative pipeline, committed to comprehensively addressing significant unmet clinical needs in obesity and broader therapeutic areas.
