预约演示
更新于：2026-08-04
BGM-0504
更新于：2026-08-04
概要
基本信息
药物类型 合成多肽 |
别名 BGM 0504、BGM-0504、BGM0504 |
作用方式 激动剂 |
作用机制 GIPR激动剂(胃抑素受体激动剂)、GLP-1R激动剂(胰高血糖素样肽-1激动剂) |
治疗领域 |
非在研适应症- |
非在研机构- |
最高研发阶段申请上市 |
首次获批日期- |
最高研发阶段(中国)申请上市 |
特殊审评- |
登录后查看时间轴
关联
20
项与 BGM-0504 相关的临床试验NCT07743983
A Randomized, Open-Label, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety, and Diabetes Remission of BGM0504 Injection Compared With Semaglutide Injection in Early-Stage Chinese Type 2 Diabetes Mellitus Patients With Obesity and Inadequate Glycemic and Weight Control Despite Diet and Exercise Intervention（BRIGHT-1）
CTR20262562
BGM0504注射液多剂量笔和单剂量笔在超重/肥胖试验参与者中的单中心、单剂量、随机、开放、单周期、平行的生物等效性研究
NCT07658560
A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of BGM0504 Tablets in Overweight or Obese Participants Without Diabetes
100 项与 BGM-0504 相关的临床结果
登录后查看更多信息
100 项与 BGM-0504 相关的转化医学
登录后查看更多信息
100 项与 BGM-0504 相关的专利（医药）
登录后查看更多信息
2
项与 BGM-0504 相关的文献（医药）2025-04-01DIABETES OBESITY & METABOLISM
The safety, tolerability, pharmacokinetics and pharmacodynamics of an optimized dual
GLP
‐1/
GIP
receptor agonist (
BGM0504
) in healthy volunteers: A dose‐escalation Phase I study
Article
作者: Long, Shuxian ; Yuan, Jiandong ; Zou, Wenhong ; Chen, Jion ; Wen, Weibo ; Ding, Haifeng ; Guan, Runfang ; Huang, Yu ; Yang, Mei ; Li, Ruixia ; Xie, Daosheng ; Fan, Yuxin ; Yu, Chongjing ; Dong, Lichun ; He, Jianchang
Abstract:
Objective:
Previous experiments have demonstrated that BGM0504, a GLP‐1R/GIPR dual agonist drug by molecular dynamics‐guided optimization, had enhanced agonistic activity compared to tirzepatide. This study aims to investigate its safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) in Chinese healthy volunteers.
Methods:
A randomized, double‐blind, placebo‐controlled and dose‐escalation Phase I study was conducted as follows: a single dose (2.5 mg) and once‐weekly administration for 2 weeks to reach target doses (5, 10 and 15 mg) by titration.
Results:
A total of 40 volunteers received at least one dose of BGM0504 or placebo. The PK profile of BGM0504 was investigated over a wide dose range and supported once‐weekly administration. It was observed that
Cmax
and AUC of BGM0504 were linearly proportional to the dose from 2.5–15 mg. The change in body weight (%) from baseline in BGM0504 groups was greater than that in the placebo group, with −3.24%, −6.26%, −7.09% and − 8.30% in 2.5, 5, 10 and 15 mg groups, respectively, indicating a certain dose correlation. Meanwhile, the potential roles of BGM0504 in glycaemic control were also observed. The most frequent adverse events reported were gastrointestinal (vomiting, nausea, decreased appetite, diarrhoea and abdominal distension).
Conclusion:
BGM0504 was generally safe and well tolerated with favourable PK profile and potential role in weight loss was also confirmed. These findings support subsequent development of BGM0504 for type 2 diabetes mellitus (T2DM) and obesity.
DIABETES OBESITY & METABOLISM
Evaluation of the Safety, Efficacy and Pharmacokinetics of
BGM0504
in Chinese Adults With Type 2 Diabetes: A Multicentre, Randomised, Controlled and Double‐Blind Phase
II
Trial
Article
作者: Xie, Daosheng ; Jiang, Xiaohui ; Huang, Yangqing ; Ji, Linong ; Ding, Haifeng ; Yuan, Xuemei ; Zhang, Haibin ; Cao, Zhao ; Yuan, Jiandong ; Jin, Ping
ABSTRACT:
Aim:
This study aimed to evaluate its safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy in Chinese adults with T2DM and to preliminarily compare its efficacy and safety with semaglutide through multiple subcutaneous injections.
Materials and Methods:
In this multicentre, randomised, placebo‐controlled and semaglutide‐positive‐controlled trial, 64 Chinese adults with T2DM were randomly assigned to BGM0504 5 mg (
n
= 12), 10 mg (
n
= 12), 15 mg (
n
= 12), placebo (
n
= 12) or semaglutide 1 mg (
n
= 16). All participants received their assigned dose once weekly for 12 weeks. The primary endpoint was the change in HbA1c from baseline, and secondary endpoints included fasting plasma glucose (FPG), 2‐h plasma glucose (2 h PG) and body weight. Safety was assessed through adverse events, laboratory tests and vital signs.
Results:
At Week 12, the mean changes in HbA1c from baseline were −1.72% for the 5 mg dose, −1.94% for the 10 mg dose, −2.48% for the 15 mg dose, −1.43% for 1 mg semaglutide and 0.28% for placebo, with the treatment differences versus placebo (LSM) ranging from −1.82% to −2.56% (all
p
< 0.05). The proportion of participants achieving HbA1c < 6.5% or < 7.0% increased in a dose‐dependent manner. BGM0504 also shows a signal for lowering FPG, 2 h PG and body weight (all
p
< 0.05), with the 15 mg dose showing superior weight reduction to semaglutide. Pharmacokinetics analysis confirmed a linear exposure–response relationship. All doses were well tolerated, with mostly mild adverse events.
Conclusion:
BGM0504 shows a signal reduction for HbA1c, FPG, 2 h PG and body weight in Chinese adults with T2DM. The 12‐week treatment with BGM0504 was safe and well‐tolerated, with the 15 mg dose showing the most substantial effects.
927
项与 BGM-0504 相关的新闻（医药）2026-08-03
2026-08-03
100 项与 BGM-0504 相关的药物交易
登录后查看更多信息
研发状态
10 条进展最快的记录, 后查看更多信息
登录
| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 肥胖 | 申请上市 | 中国 | 2026-06-11 | |
| 2型糖尿病 | 临床3期 | 中国 | 2024-11-29 | |
| 糖尿病前期 | 临床2期 | 中国 | 2026-06-30 |
登录后查看更多信息
临床结果
临床结果
适应症
分期
评价
查看全部结果
临床2期 | 64 | 餘鹹夢構範鹽積積夢網(糧繭襯齋鏇選窪淵膚醖) = 淵遞鏇醖廠膚蓋鬱憲範 範顧齋襯憲蓋積膚廠壓 (簾積憲齋膚鹹積淵夢鹽 ) 更多 | 积极 | 2025-06-20 | |||
餘鹹夢構範鹽積積夢網(糧繭襯齋鏇選窪淵膚醖) = 範願積蓋膚願壓醖製醖 範顧齋襯憲蓋積膚廠壓 (簾積憲齋膚鹹積淵夢鹽 ) 更多 | |||||||
临床2期 | 120 | (5mg) | 齋窪範鏇壓窪壓觸鑰顧(構膚窪鹽願製願獵簾淵) = 淵壓襯築膚鏇糧糧餘鹹 糧構夢繭窪淵網衊鬱顧 (餘積獵壓鏇糧餘淵鑰願 ) 更多 | 积极 | 2024-10-14 | ||
(10mg) | 齋窪範鏇壓窪壓觸鑰顧(構膚窪鹽願製願獵簾淵) = 艱遞壓艱製窪鑰鏇憲壓 糧構夢繭窪淵網衊鬱顧 (餘積獵壓鏇糧餘淵鑰願 ) 更多 | ||||||
NEWS 人工标引  | 临床2期 | 64 | 襯憲鑰製壓憲衊鏇壓餘(齋願夢鹽膚鏇衊鹽簾範) = 構鹹衊衊衊壓築鬱願積 獵築衊製壓淵衊製衊夢 (艱壓觸鏇積鬱遞鑰顧憲 ) 达到 更多 | 积极 | 2024-08-26 | ||
襯憲鑰製壓憲衊鏇壓餘(齋願夢鹽膚鏇衊鹽簾範) = 淵廠壓夢蓋醖遞繭願齋 獵築衊製壓淵衊製衊夢 (艱壓觸鏇積鬱遞鑰顧憲 ) 达到 更多 | |||||||
临床2期 | - | 衊顧製蓋衊積築願範築(壓積選積艱築淵範鬱餘) = 各剂量组受试者HbA1c、空腹血糖、餐后2h血糖等指标均较基线有显著降低。 壓蓋簾鹽餘艱餘艱衊糧 (蓋膚網襯網觸鹽願繭獵 ) 更多 | 积极 | 2024-07-09 | |||
临床1期 | 40 | 衊淵襯糧鹹窪憲簾製齋(鹹衊鏇憲窪襯廠遞淵選) = gastrointestinal adverse events like decreased appetite, nausea, abdominal distension, vomiting, and diarrhea were most common, all mild to moderate. 鏇遞夢製積獵廠醖遞醖 (觸鑰簾艱顧壓齋願構齋 ) 更多 | 积极 | 2024-06-21 |
登录后查看更多信息
转化医学
使用我们的转化医学数据加速您的研究。
登录
或
药物交易
使用我们的药物交易数据加速您的研究。
登录
或
核心专利
使用我们的核心专利数据促进您的研究。
登录
或
临床分析
紧跟全球注册中心的最新临床试验。
登录
或
批准
利用最新的监管批准信息加速您的研究。
登录
或
生物类似药
生物类似药在不同国家/地区的竞争态势。请注意临床1/2期并入临床2期，临床2/3期并入临床3期
登录
或
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
芽仔
全新生物医药AI Agent 覆盖科研全链路，让突破性发现快人一步
立即开始免费试用!
智慧芽新药情报库是智慧芽专为生命科学人士构建的基于AI的创新药情报平台，助您全方位提升您的研发与决策效率。
立即开始数据试用!
智慧芽新药库数据也通过智慧芽数据服务平台，以API或者数据包形式对外开放，助您更加充分利用智慧芽新药情报信息。
生物序列数据库
生物药研发创新
免费使用
化学结构数据库
小分子化药研发创新
免费使用