体重控制药物临床试验的现状分析

Current Analysis of Clinical Trials of Weight Control Drugs

目的:分析中国在2018至2023年间的体重控制药物临床试验的研究现况和发展趋势,为体重控制药物临床试验研究方向提供参考。方法:检索并收集我国药物临床研究注册与信息公开平台上注册的体重控制药物临床试验的详细信息。对体重控制药物临床试验发展趋势、注册特点、作用机制及主导单位的地理位置进行了分析。结果:2023年体重控制药物临床试验注册数量达到了近年来的最高点。临床Ⅰ期、Ⅱ期和Ⅲ期临床试验占87.9%(51/58),试验设计以平行、随机化和双盲试验为主。在作用靶点方面,胰高血糖素样肽-1(Glucagon-likepeptide-1,GLP-1)受体激动剂单靶点试验数量居首(27/58)。药物临床试验主导单位主要分布在北京市(27/58)、上海市(6/58)和长沙市(5/58)。结论:体重控制药物的临床试验数量呈现出上升趋势,特别是在基于GLP-1受体激动剂的单靶点及多靶点联合治疗领域的临床试验发展尤为迅猛。

Objective:This study analyzes the research status and trends of weight control drug clinical trials in China from 2018 to 2023,and provides guidance for future research.Methods:Detailed information on registered weight control drug clinical trials in Chi-na was retrieved and collected from the Chinese Clinical Trial Registry and the Information Disclosure Platform for Drug Clinical Stud-ies.Analysis was conducted on the trends in weight control drug clinical trials,registration characteristics,mechanisms of action,and geographical locations of leading institutions.Results:The number of registered weight control drug clinical trials reached its highest point in 2023.PhaseⅠ,Ⅱ,andⅢclinical trials accounted for 87.9%(51/58)of the trials,with parallel,randomized,and double-blind designs being predominant.In terms of target mechanisms,glucagon-like peptide-1(GLP-1)receptor agonists ranked first in the number of single-target trials(27/58).Leading institutions conducting drug clinical trials were primarily located in Beijing(27/58),Shanghai(6/58),and Changsha(5/58).Conclusion:The number of weight control drug clinical trials is showing an upward trend,par-ticularly in the development of clinical trials focusing on single and combination therapies targeting GLP-1 receptor agonists.