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Article(id=1292130431739122680, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292130366320562708, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2026.07.023, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1765900800000, receivedDateStr=2025-12-17, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785997501548, onlineDateStr=2026-08-06, pubDate=1776355200000, pubDateStr=2026-04-17, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785997501548, onlineIssueDateStr=2026-08-06, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785997501548, creator=13701087609, updateTime=1785997501548, updator=13701087609, issue=Issue{id=1292130366320562708, tenantId=1146029695717560320, journalId=1246415772164075586, year='2026', volume='42', issue='7', pageStart='901', pageEnd='1050', issueExtLink='null', onlineDate='null', pubDate='1776355200000', pubDateStr='2026-04-17', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785997485952, creator='13701087609', updateTime=1786014433453, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1292201449350516861, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292130366320562708, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1292201449350516862, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292130366320562708, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1041, endPage=1045, ext={EN=ArticleExt(id=1292130432309548025, articleId=1292130431739122680, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Evidence-based analysis of the current status of clinical trials for obesity and overweight drugs in China and abroad, columnId=1291704889697137247, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Special Column of Clinical Trials Administration, runingTitle=null, highlight=null, articleAbstract=
Objective

To analyze the strengths and weaknesses of China’s R&D in obesity/overweight drug clinical trials by comparing domestic and international trial characteristics, and put forward suggestions based on national conditions.

Methods

Clinical trial data of drugs for overweight/obesity were retrieved from ClinicalTrials.gov (CT.gov) and the China Drug Clinical Trial Registration and Information Disclosure Platform (Registration Platform), and divided into a domestic trial group and an international trial group. A bibliometric method was used for comparative analysis from the dimensions of drug type, dosage form, trial design, number of trials, age, gender, and sample size.

Results

Domestically, chemical drugs dominated (77.57%, 211 cases/271 cases), while international trail chemical drugs (51.30%, 256 cases/499 cases) and biological products (48.30%, 241 cases/499 cases) developed balancedly. Domestic trials focused on tablets (46.32%, 126 cases/271 cases) and injections (47.06%, 128 cases/271 cases), whereas international trials were dominated by injections (57.52%, 287 cases/499 cases) (P<0.001). Domestic randomization rate (92.25%, 250 cases/271 cases) was much higher than overseas (79.56%, 397 cases/499 cases), but blinding application was lower (44.65%, 121 cases/271 cases vs. 65.33%, 326 cases/499 cases). Few domestic trials included children (1.11%, 3 cases/271 cases), with only 3 female-specific studies.

Conclusion

Global obesity/overweight drug trials are mainly in China and the US, but China lags behind with unbalanced structure and insufficient population representativeness. China should improve R&D level through policy incentives and international cooperation based on clinical needs.

, authors=Fei LIU1, Qi-qiong DING2, Hui-qing YAO3, Xi-qian XIE3, Hai-juan Zhao3, Juan WANG3, Yue-xiong ZHANG4, Lei CAI5, Zhen-yu ZHAO1, authorsList=Fei LIU, Qi-qiong DING, Hui-qing YAO, Xi-qian XIE, Hai-juan Zhao, Juan WANG, Yue-xiong ZHANG, Lei CAI, Zhen-yu ZHAO, authorCompany=null, correspAuthors=Zhen-yu ZHAO, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1292130433056134138, articleId=1292130431739122680, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=基于循证的国内外肥胖与超重药物临床试验现状分析, columnId=1291704889869103713, journalTitle=中国临床药理学杂志, columnName=临床试验管理专栏, runingTitle=null, highlight=null, articleAbstract=
目的

通过对比国内外肥胖和超重药物临床试验特征，分析我国在该领域研发的优势与不足，并结合国情提出建议。

方法

检索美国临床试验注册中心（CT.gov）及中国药物临床试验登记与信息公示平台（登记平台）超重/肥胖药物临床试验数据，分为国内本土试验组和国外本土试验组。采用文献计量学方法，从药物类型、剂型、设计、试验数量、年龄、性别、样本量等维度进行对比分析。

结果

药物类型上，国内以化学药物（77.57%，211项/271项）为主，国外化学药物（51.30%，256项/499项）和生物制品（48.30%，241项/499项）均衡发展；剂型上，国内以片剂（46.32%，126项/271项）和注射剂（47.06%，128项/271项）为主，国外以注射剂（57.52%，287项/499项）为主，国内外剂型分布的差异有统计学意义（P<0.001）。试验设计上，国内随机化（92.25%，250项/271项）远高于国外（79.56%，397项/499项）；盲法应用（44.65%，121项/271项）低于国外（65.33%，326项/499项）。纳入人群上，国内极少纳入儿童（1.11%，3项/271项），且仅有3项女性专项研究。

结论

全球肥胖/超重药物临床试验主要集中在中美2国，但中国与美国存在差距：结构发展不均衡，纳入人群代表性不足。中国应以临床需求为源头，通过政策鼓励和加强国际合作，全面提升中国药物研发水平。

, authors=刘飞1, 丁琪琼2, 姚慧卿3, 谢茜倩3, 赵海娟3, 王娟3, 张越雄4, 蔡磊5, 赵振宇1, authorsList=刘飞, 丁琪琼, 姚慧卿, 谢茜倩, 赵海娟, 王娟, 张越雄, 蔡磊, 赵振宇, authorCompany=null, correspAuthors=赵振宇, authorNote=

刘飞（1989-），女，助理研究员，主要从事临床试验相关的研究和工作

, correspAuthorsNote=
赵振宇，主任药师，博士生导师 Tel: （022）59562083 E-mail:
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基于循证的国内外肥胖与超重药物临床试验现状分析
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刘飞 1 , 丁琪琼 2 , 姚慧卿 3 , 谢茜倩 3 , 赵海娟 3 , 王娟 3 , 张越雄 4 , 蔡磊 5 , 赵振宇 1
中国临床药理学杂志 | 临床试验管理专栏 2026,42(7): 1041-1045
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中国临床药理学杂志 |临床试验管理专栏 2026 , 42 (7) : 1041 -1045
基于循证的国内外肥胖与超重药物临床试验现状分析
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刘飞1, 丁琪琼2, 姚慧卿3, 谢茜倩3, 赵海娟3, 王娟3, 张越雄4, 蔡磊5, 赵振宇1
作者信息
  • 1.天津医科大学朱宪彝纪念医院、天津市内分泌研究所、国家卫健委激素与发育重点实验室、天津市代谢性疾病重点实验室，天津 300134
  • 2.北京协和医院 临床药理研究中心，北京 100730
  • 3.北京医院（国家老年医学中心）临床试验研究中心，老年疾病国家临床医学研究中心，国家卫生健康委老年医学重点实验室，中国医学科学院老年医学研究院
  • 4.天津市蓟州区人民医院，天津 301900
  • 5天津大学中心医院/天津市第三中心医院，天津 300170
通讯作者:
赵振宇，主任药师，博士生导师 Tel: （022）59562083 E-mail:
作者简介:

刘飞（1989-），女，助理研究员，主要从事临床试验相关的研究和工作

Evidence-based analysis of the current status of clinical trials for obesity and overweight drugs in China and abroad
Fei LIU1, Qi-qiong DING2, Hui-qing YAO3, Xi-qian XIE3, Hai-juan Zhao3, Juan WANG3, Yue-xiong ZHANG4, Lei CAI5, Zhen-yu ZHAO1
Affiliations
  • 1.NHC Key Lab of Hormones and Development and Tianjin Key Lab of Metabolic Diseases, Tianjin Medical University Chu Hsien-I Memorial Hospital & Institute of Endocrinology, Tianjin 300134, China
  • 2.Clinical Pharmacology Research Center, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, 100730, China
  • 3.Clinical Trial Center, Beijing Hospital, National Center for Gerontology; National Clinical Research Center for Gerontology; The Key Laboratory of Geriatrics of NHC; Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, P.R. China
  • 4.Tianjin Jizhou District People′s Hospital, Tianjin 301900, China
  • 5.Central Hospital, Tianjin University /Tianjin Third Central Hospital, Tianjin 300170, China
出版时间: 2026-04-17 doi: 10.13699/j.cnki.1001-6821.2026.07.023
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摘要
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目的

通过对比国内外肥胖和超重药物临床试验特征，分析我国在该领域研发的优势与不足，并结合国情提出建议。

方法

检索美国临床试验注册中心（CT.gov）及中国药物临床试验登记与信息公示平台（登记平台）超重/肥胖药物临床试验数据，分为国内本土试验组和国外本土试验组。采用文献计量学方法，从药物类型、剂型、设计、试验数量、年龄、性别、样本量等维度进行对比分析。

结果

药物类型上，国内以化学药物（77.57%，211项/271项）为主，国外化学药物（51.30%，256项/499项）和生物制品（48.30%，241项/499项）均衡发展；剂型上，国内以片剂（46.32%，126项/271项）和注射剂（47.06%，128项/271项）为主，国外以注射剂（57.52%，287项/499项）为主，国内外剂型分布的差异有统计学意义（P<0.001）。试验设计上，国内随机化（92.25%，250项/271项）远高于国外（79.56%，397项/499项）；盲法应用（44.65%，121项/271项）低于国外（65.33%，326项/499项）。纳入人群上，国内极少纳入儿童（1.11%，3项/271项），且仅有3项女性专项研究。

结论

全球肥胖/超重药物临床试验主要集中在中美2国，但中国与美国存在差距：结构发展不均衡，纳入人群代表性不足。中国应以临床需求为源头，通过政策鼓励和加强国际合作，全面提升中国药物研发水平。

超重  /  肥胖  /  减重  /  药物临床试验  /  临床试验注册登记
Objective

To analyze the strengths and weaknesses of China’s R&D in obesity/overweight drug clinical trials by comparing domestic and international trial characteristics, and put forward suggestions based on national conditions.

Methods

Clinical trial data of drugs for overweight/obesity were retrieved from ClinicalTrials.gov (CT.gov) and the China Drug Clinical Trial Registration and Information Disclosure Platform (Registration Platform), and divided into a domestic trial group and an international trial group. A bibliometric method was used for comparative analysis from the dimensions of drug type, dosage form, trial design, number of trials, age, gender, and sample size.

Results

Domestically, chemical drugs dominated (77.57%, 211 cases/271 cases), while international trail chemical drugs (51.30%, 256 cases/499 cases) and biological products (48.30%, 241 cases/499 cases) developed balancedly. Domestic trials focused on tablets (46.32%, 126 cases/271 cases) and injections (47.06%, 128 cases/271 cases), whereas international trials were dominated by injections (57.52%, 287 cases/499 cases) (P<0.001). Domestic randomization rate (92.25%, 250 cases/271 cases) was much higher than overseas (79.56%, 397 cases/499 cases), but blinding application was lower (44.65%, 121 cases/271 cases vs. 65.33%, 326 cases/499 cases). Few domestic trials included children (1.11%, 3 cases/271 cases), with only 3 female-specific studies.

Conclusion

Global obesity/overweight drug trials are mainly in China and the US, but China lags behind with unbalanced structure and insufficient population representativeness. China should improve R&D level through policy incentives and international cooperation based on clinical needs.

overweight  /  obesity  /  weight loss  /  pharmaceutical clinical trials  /  clinical trial registration
刘飞, 丁琪琼, 姚慧卿, 谢茜倩, 赵海娟, 王娟, 张越雄, 蔡磊, 赵振宇. 基于循证的国内外肥胖与超重药物临床试验现状分析. 中国临床药理学杂志, 2026 , 42 (7) : 1041 -1045 . DOI: 10.13699/j.cnki.1001-6821.2026.07.023
Fei LIU, Qi-qiong DING, Hui-qing YAO, Xi-qian XIE, Hai-juan Zhao, Juan WANG, Yue-xiong ZHANG, Lei CAI, Zhen-yu ZHAO. Evidence-based analysis of the current status of clinical trials for obesity and overweight drugs in China and abroad[J]. Chinese Journal of Clinical Pharmacology, 2026 , 42 (7) : 1041 -1045 . DOI: 10.13699/j.cnki.1001-6821.2026.07.023
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  • 天津市医学重点学科建设基金资助项目(TJYXZDXK-3-007B)
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2026年第42卷第7期
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doi: 10.13699/j.cnki.1001-6821.2026.07.023
  • 接收时间：2025-12-17
  • 首发时间：2026-08-06
  • 出版时间：2026-04-17
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  • 收稿日期：2025-12-17
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天津市医学重点学科建设基金资助项目(TJYXZDXK-3-007B)
作者信息
    1.天津医科大学朱宪彝纪念医院、天津市内分泌研究所、国家卫健委激素与发育重点实验室、天津市代谢性疾病重点实验室，天津 300134
    2.北京协和医院 临床药理研究中心，北京 100730
    3.北京医院（国家老年医学中心）临床试验研究中心，老年疾病国家临床医学研究中心，国家卫生健康委老年医学重点实验室，中国医学科学院老年医学研究院
    4.天津市蓟州区人民医院，天津 301900
    5天津大学中心医院/天津市第三中心医院，天津 300170

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赵振宇，主任药师，博士生导师 Tel: （022）59562083 E-mail:
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2种不同金属材料的力学参数
科
Family		 属数
Number of
genus		 种数
Number of
species		 占总种数比例
Percentage of
total species (%)		 属
Genus		 种数
Number of
species		 占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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