Hengrui Medicine Discloses Positive Topline Results from the Second Pivotal Phase III Type 2 Diabetes Study (OUTSTAND-2) in China for its Oral Small Molecule GLP-1 Receptor Agonist HRS-7535 – ByDrug

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This study included 810 adult participants with type 2 diabetes, with a mean HbA1c of 8.60% at baseline. a. Under the primary estimated targetⁱ, all HRS-7535 dose groups showed statistical significance compared to the control group (p < 0.0001). Primary estimated target analysis resultsⁱ showed that at week 32, the HbA1c reduction from baseline was 1.58%, 1.50%, 1.68%, and 1.28% in the HRS-7535 30 mg, 60 mg, and 90 mg dose groups and the dapagliflozin 10 mg group, respectively. All HRS-7535 dose groups achieved the primary endpoint, demonstrating superior glycemic efficacy compared to dapagliflozin. Furthermore, at week 32 of treatment, the rates of achieving HbA1c ≤ 6.5% were 41.4% in the HRS-7535 30 mg, 60 mg, and 90 mg dose groups, and 16.1% in the dapagliflozin 10 mg group, respectively. HRS-7535 demonstrated potent glucose-lowering effects while also providing multiple metabolic and target organ protection benefits. At week 32 of treatment, body weight, systolic blood pressure, lipid profile, and urine albumin/creatinine ratio (UACR) all showed positive improvements, fully demonstrating its multidimensional clinical value beyond simple glucose-lowering. HRS-7535 demonstrated good safety and tolerability in OUTSAND-2. Most adverse events during treatment were mild to moderate, mainly gastrointestinal. No grade 3 hypoglycemic events were reported. Consistent with previous studies of HRS-7535 and the known safety profile of GLP-1 receptor agonists, no new risk signals were observed. ⁱ The primary estimation target employs a hypothetical strategy: following the occurrence of the comorbid event, it is assumed that the subject adheres to the treatment protocol, and related data are excluded from the analysis. OUTSTAND-2 study results showed that HRS-7535 met all primary endpoints, demonstrating superior glucose-lowering efficacy compared to dapagliflozin. In adult patients with type 2 diabetes whose blood glucose levels were not adequately controlled after metformin treatment, HRS-7535 reduced HbA1c by 1.50%–1.68% across all dose groups (1.28% reduction in the dapagliflozin group). HRS-7535 showed improvements in multiple high-risk factors for cardiovascular and renal disease, including weight, blood pressure, blood lipids, and proteinuria. Safety profile was consistent with known characteristics of GLP-1 receptor agonists, with no new risk signals observed. Hengrui Medicine plans to submit a marketing application for HRS-7535 for the treatment of type 2 diabetes in China this year. On June 18,2026, Hengrui Medicine and Kailera Therapeutics (Kailera) jointly announced. . . The oral small-molecule GLP-1 receptor agonist HRS-7535 (known as KAI-7535 outside Greater China) achieved positive topline results in a Phase III clinical trial (OUTSTAND-2) in 810 adult subjects with type 2 diabetes in China. 1 The primary endpoint data at 32 weeks showed that the HbA1c reduction in the HRS-7535 dose group was 1.50%–1.68%i. Based on the positive topline results from the OUTSTAND-1 and OUTSTAND-2 studies, Hengrui Medicine plans to submit a marketing application for HRS-7535 for the treatment of type 2 diabetes in China this year. The Phase III clinical trial (HARBOR-1) of HRS-7535 for overweight or obesity in China is ongoing, and relevant data will be disclosed in 2026. Kailera is currently conducting a global Phase II clinical trial of KAI-7535 for obesity. The OUTSTAND-2 clinical trial (protocol number: HRS-7535-302) is a multicenter, randomized, double-blind, dapagliflozin-controlled phase III clinical trial conducted by Hengrui Medicine in China (Clinical Trial Registration No. : NCT06589765). It aims to evaluate the efficacy and safety of HRS-7535 in adult (18-75 years old) patients with type 2 diabetes whose glycemia is inadequate after metformin treatment. The study enrolled 810 participants, who were randomized in a 1: 1: 1: 1 ratio to receive once-daily oral HRS-7535 30 mg, 60 mg, or 90 mg, or dapagliflozin 10 mg. The primary endpoint was the change in HbA1c relative to baseline at week 32 of treatment. The core treatment period was 32 weeks, after which all participants entered an extension treatment period to week 52. Based on its forward-looking strategy in the field of metabolic diseases, Hengrui Medicine has established a leading and differentiated GLP-1 asset portfolio and a rich next-generation innovation pipeline, committed to comprehensively meeting significant unmet clinical needs in obesity and broader areas. HRS-7535 is an oral small-molecule glucagon-like peptide-1 (GLP-1) receptor agonist independently developed by Hengrui Medicine. It is administered orally once daily, and its absorption is unaffected by food or water intake, requiring no strict fasting conditions or waiting time after administration, making it flexible and convenient. Currently, in addition to the OUTSTAND series trials, HRS-7535 is also undergoing multiple Phase II-III clinical trials in China, covering multiple indications including weight management (HARBOR series trials) and chronic kidney disease (RENEW-CKD trial). May 2024Hengrui Medicine has granted Kailera exclusive rights to develop, manufacture, and commercialize its portfolio of GLP-1 innovative drugs, including HRS-7535, outside of Greater China. Kailera is currently conducting a global Phase II clinical trial of KAI-7535 (code name outside Greater China) for the treatment of obesity, with data expected to be released in 2027.