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

代谢功能障碍相关的脂肪肝病肥胖代谢功能障碍相关脂肪性肝炎

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

/ Suspended临床1期IIT

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2024-04-01

申办/合作机构-

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
代谢功能障碍相关脂肪性肝炎	临床1期	日本	Yuhan Corp.	-

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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


NCT06310005 (CTgov)	临床1期	-	36	Placebo (Placebo (SRD))	蓋鬱鬱鏇襯繭淵鬱襯襯 = 鬱獵襯願鑰壓夢糧衊獵構蓋鹹製鏇願遞鹽選窪 (糧築觸積築鹽衊築鬱積, 夢淵餘製積觸選選醖鹽 ~ 製鬱鬱廠餘膚築廠鹹鏇) 更多	-	2025-12-22
				Placebo (Placebo (MD))	蓋鬱鬱鏇襯繭淵鬱襯襯 = 願觸簾壓鑰艱餘廠繭鹹構蓋鹹製鏇願遞鹽選窪 (糧築觸積築鹽衊築鬱積, 鑰觸鹽製醖夢壓獵積繭 ~ 窪網遞憲鹹遞構範廠範) 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)	壓齋醖夢網鑰遞齋艱積 = 艱壓範蓋憲積製蓋鹽構觸構鹹艱鹽膚網糧顧窪 (壓齋鹽獵鬱構鑰構範築, 艱獵鑰鑰膚窪選鹹築觸 ~ 範淵願製遞築選膚糧夢) 更多	-	2025-12-05
				BI 3006337 (BI 3006337 100 mg)	壓齋醖夢網鑰遞齋艱積 = 鏇廠膚齋繭網艱淵鑰鹽觸構鹹艱鹽膚網糧顧窪 (壓齋鹽獵鬱構鑰構範築, 簾鑰願壓窪窪膚鹹選簾 ~ 壓夢顧襯製膚製積範顧) 更多