Logo 1 Logo 2

Clinical Trial Details

Trial ID: L4804
Source ID: NCT06118008
Associated Drug: Hs-20094 5mg
Title: A Study of HS-20094 in T2DM Participants
Acronym:
Status: RECRUITING
Study Results: NO
Results:
Conditions: Type 2 Diabetes
Interventions: DRUG: HS-20094 5mg|DRUG: HS-20094 10mg|DRUG: HS-20094 15mg|DRUG: HS-20094 20mg
Outcome Measures: Primary: Incidence of adverse event (AE), serious adverse event (SAE), AE leading to study discontinuation, AE severity and relation with study drug, A summary of AEs and SAEs, AE leading to study discontinuation, AE severity and relation with study drug will be reported in the reported adverse events module, From Baseline to Day 57.|The number of participants with changes of laboratory tests blood routine, urine routine, blood biochemistry, coagulation function, From Baseline to Day 57|The changes ECG examination assessed by PR, R-R, QRS and QTcF, 12-lead electrocardiogram (ECG) parameters, From Baseline to Day 57|The changes in Blood pressure, Vital signs, From Baseline to Day 57|Pulse rate, Vital signs, From Baseline to Day 57|Respiratory rate, Vital signs, From Baseline to Day 57|Temperature, Vital signs, From Baseline to Day 57 | Secondary: Pharmacokinetics (PK): Cmax of HS-20094, PK: Cmax of HS-20094, Baseline to Day 57|Pharmacokinetics (PK): Tmax of HS-20094, PK: Tmax of HS-20094, Baseline to Day 57|Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of HS-20094, PK: AUC of HS-20094, Baseline to Day 57|Pharmacodynamics (PD): HbA1c, PD: change of HbA1c, Baseline to Day 29
Sponsor/Collaborators: Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 96
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2023-05-30
Completion Date: 2024-02-01
Results First Posted:
Last Update Posted: 2023-11-07
Locations: Peking University First Hospital, Beijing, Beijing, China
URL: https://clinicaltrials.gov/show/NCT06118008