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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HSK31679 low dose | Experimental |
| |
| HSK31679 medium dose | Experimental |
| |
| HSK31679 high dose | Experimental |
| |
| Placebo | Placebo Comparator |
| |
| Ezetimibe | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HSK31679 low dose | Drug | HSK31679 low dose and placebo of HSK31679 ,QD,oral,Day1 to week 12 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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; | 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; | Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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; | Week2,4,8 |
| The proportion of patients with MRI-PDFF decreased by > 30% |
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Inclusion Criteria:
Exclusion Criteria:
Did not discontinue any lipid-regulating therapy or any drug or supplement that may affect lipid levels 6 weeks before randomization or is expected to do so during the study period.
Homozygous familial hypercholesterolemia (HoFH) was diagnosed by genetic or clinical criteria.
Dyslipidemia caused by other diseases or drugs, such as rheumatoid arthritis, nephrotic syndrome, Cushing's syndrome, hypothyroidism, renal failure, systemic lupus erythematosus, glycogen accumulation, myeloma, lipodystrophy, acute porphyria, polycystic ovarian syndrome, etc
Before screening, LDL-C plasma exchange was performed within 12 months.
In the past, PCSK9 inhibitors, Lomitapide and Mipomersen were used for treatment.
uncontrolled hypertension had systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg at screening/baseline.
type 1 diabetes, or newly diagnosed type 2 diabetes within 1 month, or poorly controlled type 2 diabetes, or who could not maintain the same hypoglycemic regimen during the study.
Stroke or transient ischemic attack (TIA), acute coronary syndrome, stable angina attack, severe deep vein thrombosis, or pulmonary embolism occurred in the 12 months prior to screening.
Major surgery (including but not limited to: coronary or other revascularization, coronary artery bypass surgery, and transplantation) within 12 months prior to screening or planned during the study period.
Chronic systemic disease or history, including but not limited to
Bariatric surgery within 12 months at the time of screening
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tsinghua Changgung Hospital, Tsinghua University | Beijing | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40846146 | Derived | Xue F, Ma W, Gao J, Chen J, Yue W, Bu P, Chen Q, Chen H, Sheng J, Chen L, Liu F, Li G, Zhu C, Zhong B, Zhang J, Cai Q, Wang L, Chen Y, Pei Z, Yao L, Lv L, Gao Y, Xia B, Ji X, Liu Y, Du L, Ma G, Hao K, Li F, Wu T, Huo Y, Wei L. Efficacy and Safety of HSK31679 in Asian Patients With MASLD: A Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2026 Apr;24(4):1068-1078. doi: 10.1016/j.cgh.2025.08.009. Epub 2025 Aug 20. |
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| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069438 | Ezetimibe |
| ID | Term |
|---|---|
| D001384 | Azetidines |
| D001385 | Azetines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| HSK31679 medium dose | Drug | HSK31679 medium dose and placebo of HSK31679 ,QD,oral,Day1 to week 12 |
|
| HSK31679 high dose | Drug | HSK31679 high dose and placebo of HSK31679 ,QD,oral,Day1 to week 12 |
|
| Placebo | Drug | placebo ,QD,oral,Day1 to week 12 |
|
| Ezetimibe 10mg | Drug | Ezetimibe 10mg+placebo of HSK31679 ,QD,oral,Day1 to week 12 |
|
After 12 weeks of treatment, the proportion of patients with MRI-PDFF decreased by > 30%;
| 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) | 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; | 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; | 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; | Week2,4,8,12 |
| Percentage change in body weight from baseline | Percentage change in body weight from baseline after 12 weeks of treatment. | Baseline and Week 12 |
| AUC0-τ of HSK31679 (All subjects) | up to 2,4,7 weeks |
| Cmax of HSK31679 (All subjects) | up to 2,4,7 weeks |
| D009750 |
| Nutritional and Metabolic Diseases |
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |