NCT06059326

Multiple-dose Study to Evaluate the Safety,Tolerability, Pharmacokinetics and Pharmacodynamics of HSK7653 in T2DM

A Multicenter, Randomized, Double-blind, Placebo Control, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HSK7653 in Type 2 Diabetes Mellitus Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Haisco Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety, tolerability and pharmacokinetic (PK)/pharmacodynamic (PD) characteristics of HSK7653 tablets in Type 2 Diabetes Mellitus Patients.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	HSK7653 10 mg	Tablet, HSK7653 10 mg Q2W, 12 weeks
DRUG	HSK7653 25 mg	Tablet, HSK7653 25 mg Q2W, 12 weeks
DRUG	HSK7653 50 mg	Tablet, HSK7653 50 mg Q2W, 12 weeks
DRUG	Placebo	Tablet, 0 mg Q2W, 12 weeks

Timeline

• Start date: 2019-01-22
• Primary completion: 2019-11-05
• Completion: 2019-11-05
• First posted: 2023-09-28
• Last updated: 2023-09-28

Locations

1 site across 1 country: China