NCT05795517

Study of HSK31679 in Subjects With Hypercholesterolemia With Nonalcoholic Fatty Liver Disease（NAFLD）

A Phase 2 ,Multicentre, Randomised, Double Blind Double Simulation, Placebo and Positive Controlled Study to Evaluate the Efficacy and Safety of HSK31679 in Patients With Hypercholesterolemia With Non-alcoholic Fatty Liver Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 210 (actual)
• Sponsor: Haisco Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the efficacy and safety of HSK31679 tablets compared with placebo in reducing low-density lipoprotein cholesterol (LDL-C) and MRI-PDFF after 12 weeks of treatment in patients with hypercholesterolemia and non-alcoholic fatty liver disease (NAFLD).

Conditions

• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	HSK31679 low dose	HSK31679 low dose and placebo of HSK31679 ，QD，oral，Day1 to week 12
DRUG	HSK31679 medium dose	HSK31679 medium dose and placebo of HSK31679 ，QD，oral，Day1 to week 12
DRUG	HSK31679 high dose	HSK31679 high dose and placebo of HSK31679 ，QD，oral，Day1 to week 12
DRUG	Placebo	placebo ，QD，oral，Day1 to week 12
DRUG	Ezetimibe 10mg	Ezetimibe 10mg+placebo of HSK31679 ，QD，oral，Day1 to week 12

Timeline

• Start date: 2023-04-26
• Primary completion: 2024-02-20
• Completion: 2024-03-01
• First posted: 2023-04-03
• Last updated: 2024-04-09

Locations

1 site across 1 country: China