Hengrui Pharmaceuticals and Kailera Therapeutics have announced positive topline results from the Phase III OUTSTAND-1 trial of their oral small-molecule GLP-1 receptor agonist, HRS-7535 (KAI-7535), for type 2 diabetes (T2D). The study met its primary endpoint, with the 90 mg dose achieving a reduction in HbA1c of 1.68% from baseline at 32 weeks, compared to a 0.06% reduction for placebo. All three dose groups (30 mg, 60 mg, 90 mg) demonstrated significant efficacy, with over 85% of patients in the 90 mg group achieving an HbA1c level below 7.0%.

Beyond glycaemic control, the therapy also showed positive trends in weight reduction, systolic blood pressure, lipid profiles, and urinary albumin-to-creatinine ratio (UACR). The safety profile was consistent with the GLP-1 class, with most adverse events being mild-to-moderate gastrointestinal issues. Hengrui plans to submit a new drug application (NDA) in its China homeland for the T2D indication. A separate Phase III trial in overweight or obesity (HARBOR-1) is ongoing in China, with data expected in 2026, while Kailera is conducting a global Phase II obesity trial.

According to PharmCube's NextBiopharm® database, HRS-7535 is one of only six small-molecule GLP-1 receptor agonists currently in Phase III, with Eli Lilly's orforglipron being the only launched product in this space. Click here to request a free trial for NextBiopharm®.