预约演示
更新于：2026-08-15
Conveglipron
更新于：2026-08-15
概要
基本信息
原研机构 |
在研机构 |
非在研机构- |
权益机构- |
最高研发阶段临床3期 |
首次获批日期- |
最高研发阶段(中国)临床3期 |
特殊审评- |
登录后查看时间轴
结构/序列
分子式C33H35FN4O5 |
InChIKeySFKAXUUDIGSMBK-SANMLTNESA-N |
CAS号2886728-09-0 |
关联
16
项与 Conveglipron 相关的临床试验NCT07594847
A Phase I, Single-center, Randomized, Double-blind, Placebo- and Positive-controlled, Four-period, Crossover Clinical Study to Evaluate the Effect of HDM1002 Tablets on Cardiac Repolarization in Healthy Subjects
NCT07331389
A Phase I, Single-center, Open-Label, Single-Arm, Fixed-Sequence Study to Evaluate the Drug-Drug Interaction of HDM1002 and Metformin, Empagliflozin, Midazolam, Valsartan, and Warfarin in Overweight/Obese Adult Chinese Subjects
NCT07193459
A Phase 3, Randomized, Double-blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of HDM1002 Tablets in Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise Only
100 项与 Conveglipron 相关的临床结果
登录后查看更多信息
100 项与 Conveglipron 相关的转化医学
登录后查看更多信息
100 项与 Conveglipron 相关的专利（医药）
登录后查看更多信息
3
项与 Conveglipron 相关的文献（医药）2026-04-01Obesity
Article
作者: Zhao, Lin ; Zhang, Guangyang ; Shen, Lijun ; Hu, Wei ; Xu, Junfang ; Li, Xiaoying ; Zhong, Liping ; Liu, Jing ; Tu, Wenwen ; Xu, Hongrong
ABSTRACT:
Objective:
HDM1002, a small‐molecule agonist of glucagon‐like peptide‐1 receptors, was evaluated for safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD).
Methods:
Chinese participants (18–60 years) with BMI ≥ 24.0 kg/m
2
to ≤ 36.0 kg/m
2
without diabetes were enrolled and randomized 5:1 (12 per cohort) to receive HDM1002 or placebo orally for 28 days. Dose cohorts included 50 mg once daily (QD); 100 mg QD; 200 mg QD; 100 mg twice daily (BID); and 400 mg QD. Primary endpoint was safety, assessed by treatment‐emergent adverse events (TEAEs), vital signs, physical examination, electrocardiogram, and laboratory parameters. Secondary endpoints were PK/PD analyses.
Results:
TEAEs in 50/100/200 mg QD, 100 mg BID, and 400 mg QD HDM1002 groups were 80%, 70%, 100%, 90%, and 100%, respectively, and 60% in the placebo group, all mild/moderate. Two participants discontinued HDM1002 due to TEAEs versus none in the placebo group. Greater least squares mean reductions from baseline in body weight were among HDM1002 200 mg QD (−6.1 kg), 100 mg BID (−4.4 kg), and 400 mg QD (−4.3 kg) groups, compared with placebo (−1.6 kg). There was no significant effect on glycemia observed with HDM1002 compared to placebo. PK were generally doseproportional.
Conclusions:
HDM1002 demonstrated a manageable safety/tolerability profile.Trial Registration:
CTR20233390
2025-10-01DIABETES OBESITY & METABOLISM
First‐in‐human study of
HDM1002
, a
GLP
‐1 receptor agonist: Safety, tolerability, pharmacokinetics and pharmacodynamics of escalating single oral doses in healthy volunteers
Article
作者: Pu, Junliang ; Huang, Yurui ; Wei, Huili ; Wan, Lei ; Tang, Chengyong ; Xu, Junfang ; Gao, Hong ; Zhong, Liping ; Zhu, Mingxue
Abstract:
Aims:
To evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single oral doses of HDM1002 in healthy adult participants.
Materials and Methods:
This was a first‐in‐human, randomized, double‐blind, placebo‐controlled, 2‐part study. Healthy participants aged 18 to 55 years with a body mass index (BMI) of 19.0 ~ 32.0 kg/m
2
were eligible. In the single ascending dose (SAD) part, eligible participants were randomized (8:2) to receive a single oral escalating dose of HDM1002 (10–600 mg) or placebo. In the food effect (FE) part, participants were randomized (7:7) to receive HDM1002 (200 mg) in the fasted and fed states with a two‐period, crossover design.
Results:
A total of 79 participants enrolled and completed the study. The most common adverse events (AEs) were nausea, diarrhoea, vomiting and decreased appetite, which increased in a dose‐dependent manner. No serious AEs were reported.
Cmax
and AUC appeared to be dose‐proportional from 10 to 600 mg by a power model. The geometric mean
t
1/2
z
ranged from 4.99 to 7.10 h.
Cmax
and AUC of HDM1002 were similar under fed and fasted conditions. HDM1002 significantly lowered postprandial glucose in a dose‐dependent manner and maintained the glucose‐lowering effect at both 6 and 12 h at 100–600 mg doses.
Conclusions:
HDM1002 was safe and well tolerated at 10–600 mg. HDM1002 showed linear pharmacokinetics, and a standardized high‐fat meal did not impact systemic exposure. These results provide preliminary evidence supporting further clinical development of HDM1002 in individuals with type 2 diabetes.
DIABETES OBESITY & METABOLISM
Pharmacokinetics and Food Effect of
HDM1002
, a Novel Oral Small‐Molecule
GLP
‐1 Receptor Agonist, in Healthy Chinese Volunteers: A Bioequivalence Study
Article
作者: Wu, Yi ; Huang, Xiangxin ; Huang, Chunqi ; Ye, Lijun ; Ying, Yiyang ; Cai, Shufan ; Wang, Ying ; Wang, Lin
ABSTRACT:
Purpose:
HDM1002 is a potent, orally active, and highly selective small‐molecule full agonist of the glucagon‐like peptide‐1 receptor (GLP‐1R), independently developed by Hangzhou Sino‐American Huadong Pharmaceutical Co. Ltd. Our aim was to evaluate the pharmacokinetics, relative bioavailability, and food effects of two tablet strengths (100 and 200 mg) of HDM1002 in Chinese health volunteers (HVs).
Methods:
This single‐centre, randomised, open‐label, single‐dose, two‐formulation, three‐period, double‐crossover phase I study enrolled 33 HVs. All subjects received each of the following three treatments in different periods: (A) two 100‐mg tablets under fasting conditions; (B) a single 200‐mg tablet under fasting conditions; and (C) a single 200‐mg tablet following a high‐fat meal. A washout period of 7 days was implemented. The plasma concentrations of HDM1002 were measured using HPLC‐MS/MS method, and PK parameters were determined by non‐compartmental analysis.
Results:
Under fasting conditions, the 90% confidence intervals (CI) for the geometric mean ratios (two 100‐mg tablets vs. one 200‐mg tablet) of
Cmax
, AUC
0‐t
, AUC
0‐∞
were 106.87% (91.42%, 124.92%), 99.64% (95.32%, 104.15%), and 99.55% (95.20%, 104.09%), respectively, all within the 80.00%–125.00% bioequivalence range. For the food effect on the 200‐mg tablet, the 90% CI of
Cmax
(fed vs. fasted) was 87.53% (76.88%, 99.66%), with its lower limit slightly below 80.00%; AUC
0‐t
and AUC
0‐∞
were 105.90% (99.80%, 112.37%) and 106.01% (99.92%, 112.47%), both within the range. And there were no serious adverse events (AEs) occurred.
Conclusion:
HDM1002 was well‐tolerated and safe. The two tablet strengths (100 and 200 mg) were bioequivalent under fasting conditions. A high‐fat meal modestly reduced the
Cmax
of the 200‐mg tablet but did not significantly affect its overall exposure (AUC).
Trial Registration:ClinicalTrials.gov
identifier: ChiCTR2500111569
100 项与 Conveglipron 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 |
|---|---|---|---|---|
| 2型糖尿病 | 临床3期 | 中国 | 2025-07-14 | |
| 肥胖 | 临床3期 | - | 2025-03-28 |
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 | 185 | HDM1002 100 mg BID | 醖襯遞膚夢構網鬱鑰鑰(襯繭衊積艱構繭範範鬱) = 簾遞壓鹹廠繭製繭積齋 鏇積膚觸蓋鬱齋選選齋 (膚蓋衊顧夢積襯製襯選 ) 更多 | 积极 | 2026-06-20 | ||
醖襯遞膚夢構網鬱鑰鑰(襯繭衊積艱構繭範範鬱) = 構艱齋鹽繭壓鏇廠夢網 鏇積膚觸蓋鬱齋選選齋 (膚蓋衊顧夢積襯製襯選 ) 更多 | |||||||
临床2期 | 185 | 獵繭廠築鹹顧襯構糧衊(鬱淵艱襯壓簾鏇築衊廠) = 鹹壓齋積製鏇鏇網構範 顧齋壓蓋鹹製衊獵衊餘 (繭積製淵繭簾繭餘鏇艱 ) 更多 | 积极 | 2025-08-04 | |||
Conveglipron 200 mg QD | 獵繭廠築鹹顧襯構糧衊(鬱淵艱襯壓簾鏇築衊廠) = 糧淵糧壓鹹製簾襯觸蓋 顧齋壓蓋鹹製衊獵衊餘 (繭積製淵繭簾繭餘鏇艱 ) 更多 | ||||||
ADA2025 | NEWS 人工标引  | 临床1期 | 58 | 廠鏇淵範顧廠壓夢積壓(觸築齋顧廠廠築築簾繭) = 憲鏇襯壓鏇繭鹹繭繭憲 憲遞蓋積顧醖鏇憲鹹網 (膚觸餘鹽襯窪構獵簾構 ) 更多 | 积极 | 2025-06-20 | ||
HDM1002 ≥200mg | 廠鏇淵範顧廠壓夢積壓(觸築齋顧廠廠築築簾繭) = 夢蓋鏇鑰顧憲顧築繭蓋 憲遞蓋積顧醖鏇憲鹹網 (膚觸餘鹽襯窪構獵簾構 ) 更多 | ||||||
临床1期 | 60 | (dose titration) | 廠齋構範遞衊餘範鏇構(廠獵獵壓願廠鹽繭範壓) = There were no deaths or serious AEs 鑰網網製餘餘積醖構糧 (窪窪選簾窪齋壓鏇鹽築 ) 更多 | 积极 | 2025-06-20 | ||
临床1期 | 79 | 淵顧顧遞簾衊糧鏇夢鏇(膚觸醖壓齋鑰夢窪鏇窪) = 10mg至600mg剂量范围内呈现线性药代动力学 醖壓鏇鹹築築選遞觸蓋 (鏇蓋醖網衊築蓋觸範憲 ) 更多 | 积极 | 2024-06-20 | |||
临床1期 | 60 | 餘醖襯壓糧醖艱鏇構製(鏇顧鏇壓憲齋積製鏇壓) = 100mg或以上剂量组体重降低显著优于安慰剂组，呈现剂量依赖性， 目标剂量组范围内受试者第28天体重较基线平均下降4.9%~6.8% 鹽顧範繭窪糧鹹遞鑰壓 (壓膚簾壓窪鑰廠鑰繭觸 ) 更多 | 积极 | 2024-06-20 |
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
特殊审评
只需点击几下即可了解关键药物信息。
登录
或
提出任何生物医药研究问题
让每一步生物医药决策都精准制胜
基于十亿级生物数据与全球情报的精准 AI，赋能早期药物发现
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。
立即接入生物医药数据包
智慧芽新药库数据也通过智慧芽开放平台，以MCP或API服务形式对外开放。立即使用我们的MCP服务定制您的LLM智能体。
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