Analysis of Characteristics in Chinese-Registered Clinical Trials for Weight-Loss Medications
10.3870/j.issn.1004-0781.2025.09.023
- VernacularTitle:我国体质量控制类药物注册临床试验现状分析
- Author:
Bo QIU
1
;
Runxuan DU
;
Haotian YANG
;
Haojing SONG
;
Xue SUN
;
Congyang DING
;
Wanjun BAI
;
Zhanjun DONG
Author Information
1. 河北省人民医院药学部,石家庄 050051;河北省临床药学重点实验室,石家庄 050051
- Publication Type:Journal Article
- Keywords:
Weight-loss medication;
Drug clinical trials;
Information analysis;
Registration and information disclosure platform
- From:
Herald of Medicine
2025;44(9):1516-1520
- CountryChina
- Language:Chinese
-
Abstract:
Objective To investigate the status and developmental trends of clinical trials for weight control drugs in China,and to provide data support for sponsors,researchers,and regulatory authorities.Methods The drug clinical trial registration and information platform of the National Medical Products Administration was utilized to search for registered clinical trials of weight control drugs from November 2012 to June 2024.The search employed"overweight","obesity",and"weight loss"as keywords.The information collected included project registration time,drug name,dosage form,drug classification,indications,trial staging,study progress,design type,lead unit,and sponsor.Microsoft Office Excel software was employed for data entry,organization,and extraction.Results A total of 95 registered clinical trials of weight control drugs were identified,comprising 40 domestic multicenter trials,47 domestic single-center trials,and 8 international multicenter trials.Regarding trial phasing,46(48.4％)were phase Ⅰ clinical trials,17(17.9％)were phase Ⅱ clinical trials,19(20.0％)were phase Ⅲ clinical trials,and 13(13.7％)were bioequivalence trials.The drug categorization encompassed 22 chemical drugs,20 biological products,and 1 traditional Chinese medicine/natural drug.Concerning drug dosage forms,there were 32 items of injectable dosage forms,8 items of tablets,2 items of capsules,and 1 item of chewable tablets.Conclusions Registered clinical trials for weight-loss medications in China are predominantly concentrated in regions with developed medical resources.Injectable biologics constitute most test drugs,with most drugs in the early stages of research and development.The examination of the safety and efficacy of these drugs remains to be substantiated,and it is anticipated that a considerable period will elapse before their approval and market introduction.
