NCT05795517已完成2 期
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
Haisco Pharmaceutical Group Co., Ltd.1 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2023年4月26日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Percentage change in MRI-PDFF from baseline at 12 week；
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must be willing to participate in the study and provide written informed consent.
- •Male or female aged 18 ≤ age < 65 at the time of signing the informed consent.
- •At the time of screening, patients who had not received lipid-regulation therapy within 6 weeks had fasting LDL-C≥3.34mmol/L（130mg/dL）.
- •(BMI) ≥18kg/m2 and female subjects ≥45.0 kg and male subjects ≥50.0 kg.
- •During screening, fasting triglyceride (TG) <5.65 mmol/L.
- •During screening,MRI-PDFF≥8%.
- •Weight changes≤5% in the 4 weeks prior to screening.
排除标准
- •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
- •Have a serious cardiopulmonary disease or history,Neurological disease or history,Autoimmune disease,Chronic digestive disease or history
- •Have thyroid disease or symptomatic abnormalities in thyroid function tests (e.g., thyroid stimulating hormone (TSH) < 1.0 x lower limit of normal (LLN) or > 1.5 x upper limit of normal (ULN))
- •History of malignancy (excluding cured basal cell carcinoma of the skin, carcinoma in situ, and papillary thyroid carcinoma) or history of antitumor therapy within 5 years prior to screening
- •Disease or medical history assessed by the investigator as likely to affect the study
- •Bariatric surgery within 12 months at the time of screening
研究组 & 干预措施
Ezetimibe
Active Comparator
干预措施: Ezetimibe 10mg (Drug)
HSK31679 low dose
Experimental
干预措施: HSK31679 low dose (Drug)
HSK31679 medium dose
Experimental
干预措施: HSK31679 medium dose (Drug)
HSK31679 high dose
Experimental
干预措施: HSK31679 high dose (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage change in MRI-PDFF from baseline at 12 week；
时间窗: Baseline and Week 12
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;
Percentage change in LDL-C from baseline at 12 week;
时间窗: Baseline and Week 12
Percentage change in fasting low-density lipoprotein cholesterol (LDL-C) from baseline after 12 weeks of treatment;
次要结局
- Proportion of patients with LDL-C<3.34mmol/L（<130mg/dL）(Baseline and Week 12)
- Percentage change of fasting TG from baseline;(Week2,4,8,12)
- Percentage change of fasting HDL-C from baseline;(Week2,4,8,12)
- Cmax of HSK31679 (All subjects)(up to 2,4,7 weeks)
- The proportion of patients with MRI-PDFF decreased by > 30%(Baseline and Week 12)
- AUC0-τ of HSK31679 (All subjects)(up to 2,4,7 weeks)
- Percentage change in fasting LDL-C from baseline;(Week2,4,8)
- Percentage change of fasting TC from baseline;(Week2,4,8,12)
- Percentage change in body weight from baseline(Baseline and Week 12)
研究者
研究点 (1)
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