Dorzagliatin

Generic Name: Dorzagliatin

Drug Type: Small Molecule

Chemical Formula: C_₂₂H_₂₇ClN_₄O_₅

CAS Number: 1191995-00-2

Unique Ingredient Identifier: X59W6980E8

Background: Dorzagliatin is under investigation in clinical trial NCT03173391 (Long-term Efficacy and Safety of HMS5552 in T2DM).

Clinical Trials

Glucokinase Activator in Monogenic Diabetes

Phase 2

Not yet recruiting

Conditions: Diabetes Mellitus
Monogenic Diabetes

Interventions: Drug: Dorzagliatin
Drug: matched placebo

First Posted Date: 2025-05-16

Last Posted Date: 2025-05-16

Lead Sponsor: Chinese University of Hong Kong

Target Recruit Count: 44

Registration Number: NCT06976658

Locations: 🇭🇰
3M, Diabetes and Endocrine Research Center, Hong Kong, Hong Kong

Chronic Dorzagliatin on Insulin and Incretin Function in Intermediate Hyperglycemia and Type 2 Diabetes

Not Applicable

Not yet recruiting

Conditions: Diabetes Mellitus
Prediabetes / Type 2 Diabetes

Interventions: Drug: Dorzagliatin

First Posted Date: 2024-11-04

Last Posted Date: 2025-03-04

Lead Sponsor: Elaine Chow

Target Recruit Count: 30

Registration Number: NCT06671340

Locations: 🇭🇰
Phase 1 Clinical Trial Centre, Hong Kong, Hong Kong

A Post-Marketing Safety Study of Dorzagliatin in Patients With Type 2 Diabetes

Phase 4

Recruiting

Conditions: Type2diabetes

Interventions: Drug: Dorzagliatin tablets

First Posted Date: 2024-02-16

Last Posted Date: 2024-02-16

Lead Sponsor: Hua Medicine Limited

Target Recruit Count: 2000

Registration Number: NCT06263348

Locations: 🇨🇳
China-Japan Friendship Hospital, Beijing, Beijing, China

Effect of Dorzagliatin on Renal Function Outcomes in People With Type 2 Diabetes: a Multicentric, Prospective, Randomized Study.

Not Applicable

Not yet recruiting

Conditions: Diabetic Nephropathy Type 2

Interventions: Drug: Dorzagliatin
Drug: Gliclazide

First Posted Date: 2024-01-24

Last Posted Date: 2024-01-24

Lead Sponsor: Yan Bi

Target Recruit Count: 106

Registration Number: NCT06222476

Locations: 🇨🇳
Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University, Nanjing, Jiangsu, China

Dorzagliatin and 1st Phase Insulin and Beta-cell Glucose Sensitivity in IGT and NGT

Phase 1

Conditions: Glucose Intolerance

Interventions: Drug: Placebo
Drug: Dorzagliatin

First Posted Date: 2022-07-21

Last Posted Date: 2022-07-25

Lead Sponsor: Chinese University of Hong Kong

Target Recruit Count: 20

Registration Number: NCT05468229

Effects of Modulators of Gluconeogenesis, Glycogenolysis and Glucokinase Activity

Phase 3

Active, not recruiting

Conditions: Type 2 Diabetes

Interventions: Drug: Insulin Glargine
Drug: Metformin
Drug: Dorzagliatin

First Posted Date: 2021-10-28

Last Posted Date: 2025-05-01

Lead Sponsor: University of Alabama at Birmingham

Target Recruit Count: 100

Registration Number: NCT05098470

Locations: 🇺🇸
Rita Basu, Birmingham, Alabama, United States
🇺🇸
University of Virginia, Charlottesville, Virginia, United States

Effects of Dorzagliatin on 1st Phase Insulin and Beta-cell Glucose Sensitivity in T2D and Monogenic Diabetes

Phase 2

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Dorzagliatin
Drug: placebo

First Posted Date: 2020-08-28

Last Posted Date: 2022-07-22

Lead Sponsor: Chinese University of Hong Kong

Target Recruit Count: 18

Registration Number: NCT04531631

Locations: 🇭🇰
The Chinese University of Hong Kong, Hong Kong, Hong Kong

A Clinical Study to Access the Pharmacokinetics of HMS5552 in Hepatic Impaired Subjects and Healthy Volunteers

Phase 1

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: HMS5552

First Posted Date: 2020-06-11

Last Posted Date: 2022-11-29

Lead Sponsor: Hua Medicine Limited

Target Recruit Count: 25

Registration Number: NCT04426708

Locations: 🇨🇳
West China Hospital of Sichuan University, Chengdu, Sichuan, China

A Clinical Study to Access the Pharmacokinetics of HMS5552 in Renal Impaired Subjects and Healthy Volunteers

Phase 1

Completed

Conditions: Type 2 Diabetes Mellitus

Interventions: Drug: HMS5552

First Posted Date: 2020-03-27

Last Posted Date: 2020-03-27

Lead Sponsor: Hua Medicine Limited

Target Recruit Count: 17

Registration Number: NCT04324424

Locations: 🇨🇳
West China Hospital of Sichuan University, Chengdu, Sichuan, China

The Progress of Diabetes Mellitus After HMS5552 Treatment in Type 2 Diabetes Mellitus

Conditions: Type2 Diabetes Mellitus

Interventions: Drug: HMS5552

First Posted Date: 2019-09-17

Last Posted Date: 2021-08-26

Lead Sponsor: Majianhua

Target Recruit Count: 24

Registration Number: NCT04091854

Locations: 🇨🇳
Nanjing First hospital, Nanjing, Jiangsu, China

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