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速递|甘李药业基础胰岛素/GLP-1RA固定比例复方长效周制剂中国 II 期临床完成首例给药

Core Viewpoint - The article discusses the development and clinical trial progress of GZR102, a fixed-dose combination long-acting weekly injection of basal insulin and GLP-1 receptor agonist, by Gan Li Pharmaceutical, aimed at improving treatment for type 2 diabetes mellitus (T2DM) patients [2][4]. Group 1: Product Development - Gan Li Pharmaceutical has initiated the first dosing of GZR102 in a Phase II clinical trial for adult T2DM patients in China [2]. - The trial compares the efficacy, safety, and tolerability of GZR102 administered weekly versus GZR18 administered biweekly, with a target enrollment of 90 patients [4]. - GZR102 aims to simplify T2DM treatment pathways while significantly reducing blood sugar levels and minimizing weight gain and hypoglycemia risks associated with basal insulin alone [4]. Group 2: Clinical Trial Details - The primary endpoint of the study is the change in glycated hemoglobin (HbA1c) from baseline after 24 weeks [4]. - The innovative formulation of GZR102 maximizes the synergistic effects of its two components, potentially enhancing glycemic control while reducing the daily insulin dosage [5]. Group 3: Market Potential - GZR102 represents a novel product in the diabetes combination therapy space, with no similar fixed-dose combination long-acting weekly injections currently available globally [4]. - The product's entry into Phase II clinical trials positions it as a potential preferred option in the diabetes treatment market in China, further enriching Gan Li Pharmaceutical's product portfolio [4].