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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
210
HSK31679 low dose and placebo of HSK31679 ,QD,oral,Day1 to week 12
HSK31679 medium dose and placebo of HSK31679 ,QD,oral,Day1 to week 12
HSK31679 high dose and placebo of HSK31679 ,QD,oral,Day1 to week 12
Beijing Tsinghua Changgung Hospital, Tsinghua University
Beijing, China
Percentage change in LDL-C from baseline at 12 week;
Percentage change in fasting low-density lipoprotein cholesterol (LDL-C) from baseline after 12 weeks of treatment;
Time frame: Baseline and Week 12
Percentage change in MRI-PDFF from baseline at 12 week;
Percentage change of MRI-PDFF(change in liver fat content by nuclear magnetic resonance - Proton Density Fat Fraction) from baseline after 12 weeks of treatment;
Time frame: Baseline and Week 12
Percentage change in fasting LDL-C from baseline;
Percentage change in fasting low-density lipoprotein cholesterol (LDL-C) from baseline after 2, 4, and 8 weeks of treatment;
Time frame: Week2,4,8
The proportion of patients with MRI-PDFF decreased by > 30%
After 12 weeks of treatment, the proportion of patients with MRI-PDFF decreased by \> 30%;
Time frame: Baseline and Week 12
Proportion of patients with LDL-C<3.34mmol/L(<130mg/dL)
After 12 weeks of treatment, the proportion of patients with LDL-C\<3.34mmol/L(\<130mg/dL)
Time frame: Baseline and Week 12
Percentage change of fasting TG from baseline;
After 2, 4, 8, 12 weeks of treatment, Percentage change of fasting triglycerides (TG), from baseline;
Time frame: Week2,4,8,12
Percentage change of fasting TC from baseline;
After 2, 4, 8, 12 weeks of treatment, Percentage change of fasting total cholesterol (TC) from baseline;
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placebo ,QD,oral,Day1 to week 12
Ezetimibe 10mg+placebo of HSK31679 ,QD,oral,Day1 to week 12
Time frame: Week2,4,8,12
Percentage change of fasting HDL-C from baseline;
After 2, 4, 8, 12 weeks of treatment, Percentage change of fasting high-density lipoprotein cholesterol (HDL-C) from baseline;
Time frame: Week2,4,8,12
Percentage change in body weight from baseline
Percentage change in body weight from baseline after 12 weeks of treatment.
Time frame: Baseline and Week 12
AUC0-τ of HSK31679 (All subjects)
Time frame: up to 2,4,7 weeks
Cmax of HSK31679 (All subjects)
Time frame: up to 2,4,7 weeks