BI-3006337(BI-3006337) - 药物靶点：FGF21R x GLP-1R_在研适应症：代谢功能障碍相关脂肪性肝炎，代谢功能障碍相关的脂肪肝病，肥胖_专利_临床

概要

基本信息

药物类型

Fc融合蛋白

别名

BI 3006337、BI-3006337

靶点

FGF21R x GLP-1R

作用方式

激动剂

作用机制

FGF21R激动剂、GLP-1R激动剂(胰高血糖素样肽-1激动剂)

治疗领域

消化系统疾病内分泌与代谢疾病

在研适应症

代谢功能障碍相关脂肪性肝炎代谢功能障碍相关的脂肪肝病肥胖

非在研适应症-

原研机构

Boehringer Ingelheim GmbH

在研机构

Boehringer Ingelheim GmbHYuhan Corp.

非在研机构-

权益机构-

最高研发阶段临床1期

首次获批日期-

最高研发阶段(中国)-

特殊审评-

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关联

5

项与 BI-3006337 相关的临床试验

NCT06310005

/ Completed临床1期

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Rising Subcutaneous Doses and Multiple Subcutaneous Doses Over 6 Weeks of BI 3006337 in Healthy Male Japanese Subjects (Single-blind, Randomised Within Dose Groups, Placebo-controlled, Parallel Group Design)

The main objectives of this trial are to investigate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of BI 3006337 in healthy male subjects following s.c. administration of single rising doses and multiple doses over 6 weeks.

开始日期2024-04-19

申办/合作机构

Boehringer Ingelheim GmbH

JPRN-jRCT2031230638

/ Not yet recruiting临床1期

Safety, tolerability, pharmacokinetics, and pharmacodynamics of single rising subcutaneous doses and multiple subcutaneous doses over 6 weeks of BI 3006337 in healthy male Japanese subjects (single-blind, randomised within dose groups, placebo-controlled, parallel group design)

开始日期2024-02-16

申办/合作机构

Boehringer Ingelheim GmbH

NCT05970640

/ Completed临床1期

Phase Ib Trial to Assess Safety and Tolerability of Multiple Subcutaneous Doses of BI 3006337 in Patients With Overweight or Obesity and Hepatic Steatosis

This study is open to adults with overweight or obesity who also have fatty liver disease. The purpose of this study is to find the highest dose of BI 3006337 that people with overweight or obesity and with fatty liver disease can tolerate.
Participants are divided into 4 groups of equal size randomly, which means by chance. Different doses of BI 3006337 are given to participants in each group. Participants in each group receive an injection of either BI 3006337 or placebo once a week. Placebo injections look like BI 3006337 injections but do not contain any medicine.
Participants are in the study for about 4 months. During this time, they visit the study site 18 times. Three of the visits include overnight stays at the study site. The doctors check the health of the participants and note any health problems that could have been caused by BI 3006337.

开始日期2023-08-14

申办/合作机构

Boehringer Ingelheim GmbH

100 项与 BI-3006337 相关的临床结果

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100 项与 BI-3006337 相关的转化医学

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100 项与 BI-3006337 相关的专利（医药）

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100 项与 BI-3006337 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
代谢功能障碍相关脂肪性肝炎	临床1期	日本	Boehringer Ingelheim GmbH	2024-02-16
代谢功能障碍相关的脂肪肝病	临床1期	美国	Boehringer Ingelheim GmbH	2023-08-14
肥胖	临床1期	美国	Boehringer Ingelheim GmbH	2023-08-14

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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05076422 (EASL2026)	临床1期	脂肪肝	143	BI 3006337	鏇蓋簾鏇憲鑰鏇網顧鹽(範淵衊鏇膚夢範淵鏇艱) = 壓艱衊鹹醖襯選觸廠觸淵築選觸觸鏇願醖廠淵 (獵鹹顧選鏇蓋選壓鏇網 )	积极	2026-05-27
				BI 3006337 150 mg	鏇蓋簾鏇憲鑰鏇網顧鹽(範淵衊鏇膚夢範淵鏇艱) = 簾淵簾窪憲鑰繭齋鏇蓋淵築選觸觸鏇願醖廠淵 (獵鹹顧選鏇蓋選壓鏇網 )
NCT06310005 (CTgov)	临床1期	-	36	Placebo (Placebo (SRD))	獵鏇蓋鹹鹽糧襯觸蓋獵 = 憲網壓壓衊膚憲鑰廠醖艱廠艱膚獵獵範範簾襯 (構繭鬱壓蓋衊構艱壓夢, 醖鏇願願鏇鏇網膚襯觸 ~ 網網構廠廠鏇齋膚餘淵) 更多	-	2025-12-22
				Placebo (Placebo (MD))	獵鏇蓋鹹鹽糧襯觸蓋獵 = 鹹醖選獵積構顧繭獵顧艱廠艱膚獵獵範範簾襯 (構繭鬱壓蓋衊構艱壓夢, 網膚鏇構鑰選鑰衊鏇壓 ~ 鏇鹹選繭壓齋鹹繭膚艱) 更多
NCT05970640 (CTgov)	临床1期	肥胖 \| 代谢功能障碍相关的脂肪肝病	64	BI 3006337 (BI 3006337 50 mg)	襯淵簾網憲糧積醖簾選 = 蓋蓋願膚繭廠醖繭遞衊獵範艱構餘醖築觸遞鏇 (壓夢齋製襯淵憲夢壓選, 顧憲遞製遞夢壓醖鬱觸 ~ 廠構醖遞觸餘襯蓋願選) 更多	-	2025-12-05
				BI 3006337 (BI 3006337 100 mg)	襯淵簾網憲糧積醖簾選 = 簾構築簾襯糧醖鑰網鹽獵範艱構餘醖築觸遞鏇 (壓夢齋製襯淵憲夢壓選, 製窪膚網積醖餘顧鹽衊 ~ 鹽獵糧鏇觸膚構鑰構鏇) 更多