Article(id=1292126496672477276, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292126409196064779, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2026.02.024, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1766332800000, receivedDateStr=2025-12-22, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785996563356, onlineDateStr=2026-08-06, pubDate=1769529600000, pubDateStr=2026-01-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785996563356, onlineIssueDateStr=2026-08-06, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785996563356, creator=13701087609, updateTime=1785996563356, updator=13701087609, issue=Issue{id=1292126409196064779, tenantId=1146029695717560320, journalId=1246415772164075586, year='2026', volume='42', issue='2', pageStart='151', pageEnd='300', issueExtLink='null', onlineDate='null', pubDate='1769529600000', pubDateStr='2026-01-28', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785996542500, creator='13701087609', updateTime=1786014671444, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1292202447569707674, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292126409196064779, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1292202447569707675, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292126409196064779, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=297, endPage=300, ext={EN=ArticleExt(id=1292126496936718430, articleId=1292126496672477276, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Evaluation consideration for clinical research and development for adolescent weight management, columnId=1292126496848638045, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Regulatory Science Column, runingTitle=null, highlight=null, articleAbstract=

Currently, there are no approved adolescent weight management drugs in China, and there is a significant unmet medical need for adolescent weight management. With glucagon like peptide-1 receptor agonists (GLP-1 RA) design becoming a hot topic in the research and development of adolescent obesity, the number of communication and applications for clinical application in China has gradually increased. Combined with relevant problems encountered in the evaluation, we discussed the design and evaluation consideration for clinical trials of adolescent weight management, so as to improve the research and development and provide references for researchers.

, authors=Yuan-hong LI, Tian ZHAO, Yu-ying QI, Jie ZHANG, authorsList=Yuan-hong LI, Tian ZHAO, Yu-ying QI, Jie ZHANG, authorCompany=null, correspAuthors=Jie ZHANG, 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=1292126497762996320, articleId=1292126496672477276, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=青少年体重管理临床研发审评考虑, columnId=1292126497112879199, journalTitle=中国临床药理学杂志, columnName=药物监管科学专栏, runingTitle=null, highlight=null, articleAbstract=

中国目前尚无青少年体重管理药物获批,青少年体重管理存在重大未满足的医疗需求。随着胰高血糖素样肽-1受体激动剂(GLP-1 RA)类药物成为青少年体重管理领域的研发热点,国内青少年体重管理适应症的沟通交流和临床申报也逐渐增多。结合审评过程中对相关问题的审评思考,本文综述了青少年体重管理临床试验的一般性设计和审评考虑,期望为企业研发人员在青少年体重管理临床试验设计方面提供参考,从而提高研发效率,使患者早日获益。

, authors=李远红, 赵田, 綦钰莹, 张杰, authorsList=李远红, 赵田, 綦钰莹, 张杰, authorCompany=null, correspAuthors=张杰, authorNote=

李远红(1980-),女,审评员,主要从事内分泌系统药物临床审评工作

, correspAuthorsNote=
张杰,高级审评员 Tel: (010)80995699 E-mail:
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李远红(1980-),女,审评员,主要从事内分泌系统药物临床审评工作

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李远红(1980-),女,审评员,主要从事内分泌系统药物临床审评工作

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青少年体重管理临床研发审评考虑
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李远红 , 赵田 , 綦钰莹 , 张杰
中国临床药理学杂志 | 药物监管科学专栏 2026,42(2): 297-300
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中国临床药理学杂志 |药物监管科学专栏 2026 , 42 (2) : 297 -300
青少年体重管理临床研发审评考虑
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李远红, 赵田, 綦钰莹, 张杰
作者信息
  • 国家药品监督管理局 药品审评中心,北京 100076
通讯作者:
张杰,高级审评员 Tel: (010)80995699 E-mail:
作者简介:

李远红(1980-),女,审评员,主要从事内分泌系统药物临床审评工作

Evaluation consideration for clinical research and development for adolescent weight management
Yuan-hong LI, Tian ZHAO, Yu-ying QI, Jie ZHANG
Affiliations
  • Center for Drug Evaluation, National Medical Products Administration, Beijing 100076, China
出版时间: 2026-01-28 doi: 10.13699/j.cnki.1001-6821.2026.02.024
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中国目前尚无青少年体重管理药物获批,青少年体重管理存在重大未满足的医疗需求。随着胰高血糖素样肽-1受体激动剂(GLP-1 RA)类药物成为青少年体重管理领域的研发热点,国内青少年体重管理适应症的沟通交流和临床申报也逐渐增多。结合审评过程中对相关问题的审评思考,本文综述了青少年体重管理临床试验的一般性设计和审评考虑,期望为企业研发人员在青少年体重管理临床试验设计方面提供参考,从而提高研发效率,使患者早日获益。

青少年  /  体重管理  /  胰高血糖素样肽-1受体激动剂  /  临床研发  /  审评考虑

Currently, there are no approved adolescent weight management drugs in China, and there is a significant unmet medical need for adolescent weight management. With glucagon like peptide-1 receptor agonists (GLP-1 RA) design becoming a hot topic in the research and development of adolescent obesity, the number of communication and applications for clinical application in China has gradually increased. Combined with relevant problems encountered in the evaluation, we discussed the design and evaluation consideration for clinical trials of adolescent weight management, so as to improve the research and development and provide references for researchers.

adolescent  /  weight management  /  glucagon-like peptide-1 receptor agonists  /  clinical research development  /  evaluation consideration
李远红, 赵田, 綦钰莹, 张杰. 青少年体重管理临床研发审评考虑. 中国临床药理学杂志, 2026 , 42 (2) : 297 -300 . DOI: 10.13699/j.cnki.1001-6821.2026.02.024
Yuan-hong LI, Tian ZHAO, Yu-ying QI, Jie ZHANG. Evaluation consideration for clinical research and development for adolescent weight management[J]. Chinese Journal of Clinical Pharmacology, 2026 , 42 (2) : 297 -300 . DOI: 10.13699/j.cnki.1001-6821.2026.02.024

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doi: 10.13699/j.cnki.1001-6821.2026.02.024
  • 接收时间:2025-12-22
  • 首发时间:2026-08-06
  • 出版时间:2026-01-28
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  • 收稿日期:2025-12-22
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    国家药品监督管理局 药品审评中心,北京 100076

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张杰,高级审评员 Tel: (010)80995699 E-mail:
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2种不同金属材料的力学参数

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Percentage of
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Genus
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Number of
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Percentage of total
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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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