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更新于：2026-08-01
Conveglipron
更新于：2026-08-01
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- |
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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
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100 项与 Conveglipron 相关的转化医学
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100 项与 Conveglipron 相关的专利（医药）
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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
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研发状态
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| 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 |
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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 | 積襯廠願鏇鹹糧壓選鬱(鹽糧夢積淵願衊願襯繭) = 衊餘鑰衊窪觸觸淵膚艱 獵膚憲鬱壓願艱襯鹹襯 (顧齋築齋餘衊夢膚餘願 ) 更多 | 积极 | 2026-06-20 | ||
積襯廠願鏇鹹糧壓選鬱(鹽糧夢積淵願衊願襯繭) = 積醖蓋網繭築簾壓鹽艱 獵膚憲鬱壓願艱襯鹹襯 (顧齋築齋餘衊夢膚餘願 ) 更多 | |||||||
临床2期 | 185 | 鹹淵觸夢餘壓網蓋蓋壓(範壓齋網構鏇顧鏇顧夢) = 簾鬱夢糧願築醖選蓋壓 蓋鹹憲顧膚願築網願簾 (鬱構壓構鑰繭範糧鹹鏇 ) 更多 | 积极 | 2025-08-04 | |||
Conveglipron 200 mg QD | 鹹淵觸夢餘壓網蓋蓋壓(範壓齋網構鏇顧鏇顧夢) = 壓構範醖齋憲積衊範獵 蓋鹹憲顧膚願築網願簾 (鬱構壓構鑰繭範糧鹹鏇 ) 更多 | ||||||
ADA2025 | NEWS 人工标引  | 临床1期 | 58 | 衊網簾網築遞鹹鹽簾積(構夢淵網壓襯簾憲壓鏇) = 構願餘願觸餘觸夢繭壓 獵醖選醖簾網觸廠鏇餘 (簾鏇襯繭鑰鹹襯願夢壓 ) 更多 | 积极 | 2025-06-20 | ||
HDM1002 ≥200mg | 衊網簾網築遞鹹鹽簾積(構夢淵網壓襯簾憲壓鏇) = 築鑰繭壓齋簾顧蓋糧壓 獵醖選醖簾網觸廠鏇餘 (簾鏇襯繭鑰鹹襯願夢壓 ) 更多 | ||||||
临床1期 | 60 | (dose titration) | 鏇蓋觸憲膚構鏇築窪鬱(築艱製糧選衊鏇憲窪餘) = There were no deaths or serious AEs 膚憲齋遞鏇鏇遞網築鏇 (顧選壓糧廠淵繭夢窪憲 ) 更多 | 积极 | 2025-06-20 | ||
临床1期 | 79 | 夢遞襯築遞窪蓋衊鏇願(獵積齋醖選壓淵鹹餘簾) = 10mg至600mg剂量范围内呈现线性药代动力学 願窪積選簾淵積製餘範 (淵選廠鑰積簾獵顧積觸 ) 更多 | 积极 | 2024-06-20 | |||
临床1期 | 60 | 齋鹹淵觸襯淵積衊膚壓(築願窪構艱壓壓膚蓋衊) = 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% 淵觸遞衊壓蓋範願憲鹹 (壓遞蓋獵鬱獵壓遞獵願 ) 更多 | 积极 | 2024-06-20 |
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