速递|全球首个!礼来双靶点GLP-1药物Brenipatide启动抑郁症 III 期临床

Core Viewpoint - Eli Lilly has initiated a Phase III clinical trial for Brenipatide, a dual GLP-1 and GIP receptor agonist, in adult depression patients, marking a significant expansion of GLP-1 drug applications beyond metabolic diseases into central nervous system disorders [4][5]. Group 1: Clinical Development - The RENEW-MDD-1 study aims to evaluate the efficacy and safety of Brenipatide as an adjunct therapy compared to placebo in delaying disease relapse in adults with depression, with approximately 1,000 participants globally, including 90 from China [4]. - Brenipatide is the first GLP-1 class product to enter Phase III clinical trials for depression, indicating a pioneering step in this therapeutic area [5]. Group 2: Market Context - Eli Lilly's commercial success with its core product, Tirzepatide, which achieved sales of $24.8 billion in the first three quarters of 2025, growing 125% year-over-year, supports the potential for Brenipatide's cross-indication expansion [6]. - The company is strategically broadening the potential value of the GLP-1/GIP mechanism, exploring applications in addiction, mental health, and inflammation-related diseases, beyond just glucose control and weight loss [6]. Group 3: Broader Implications - The entry of Brenipatide into the depression treatment space signifies a critical transition for GLP-1 drugs, potentially reshaping their disease landscape and offering a new biological pathway for depression treatment [7]. - If the clinical trial demonstrates clinical value in relapse prevention, it could represent a pivotal shift for GLP-1 drugs from metabolic-focused therapies to a more versatile platform molecule [7].