Hengrui ：HRS-7535 for Phase III Clinical Trial in Chronic Kidney Disease
On June 4 local time, the ClinicalTrials website showed that Hengrui Medicine registered a Phase III clinical trial of HRS-7535 for the treatment of chronic kidney disease (CKD) .
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase III study designed to demonstrate the superiority of HRS-7535 over placebo, on top of standard of care, in reducing the risk of renal adverse events and cardiovascular death in patients with chronic kidney disease (CKD). The trial plans to enroll 3,690 participants, with the primary endpoint being the time to first occurrence of any of the following renal composite endpoints.
HRS-7535 is an oral small-molecule GLP-1 receptor agonist independently developed by Hengrui Medicine. It is administered orally once daily, and its absorption is not affected by food or water intake, requiring no strict fasting conditions or waiting time after dosing, offering flexible and convenient administration.
In May 2024, Hengrui Medicine granted Kailera exclusive rights to develop, manufacture, and commercialize a portfolio of GLP-1 class innovative drugs, including HRS-7535, outside of Greater China. Kailera is currently conducting a global Phase II clinical trial of KAI-7535 (the codename outside Greater China) for the treatment of obesity, with data expected to be released in 2027.
In China, Hengrui Medicine has initiated multiple Phase III clinical studies for HRS-7535, covering indications including type 2 diabetes, obesity, hypertension, and chronic kidney disease.
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