NCT06822946已完成2 期
Zhibitai Capsules for the Treatment of Primary Hyperlipidemia (Tan yu hu Jie, qi Xue bu li Zheng) A Randomized, Double-blind, Parallel Controlled, Multicenter, Phase II Clinical Trial
Chengdu Diao Jiuhong Pharmaceutical Factory13 个研究点 分布在 1 个国家目标入组 201 人开始时间: 2025年3月27日最近更新:
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
- 201
- 试验地点
- 13
- 主要终点
- The percentage and absolute changes in serum low-density lipoprotein cholesterol (LDL-C) from baseline after 4, 8, and 12 weeks of treatment
研究概览
简要总结
Exploring the benefit risk ratio of increase in dosage of Zhibitai capsules (2 capsules at a time, 2 times a day) compared to the original dosage (1 capsule at a time, 1 day)
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 75 years old (inclusive), regardless of gender;
- •BMI (Body Mass Index) between 18.0 kg/m² and 30.0 kg/m²;
- •Meets the diagnostic criteria for primary hyperlipidemia (tan yu hu jie, qi xue bu li zheng);
- •LDL-C level ≥ 3.4 mmol/L and TG level ≤ 4.5 mmol/L;
- •Diagnosis before and after the run-in period meets the above criteria, and the absolute difference between the two LDL-C measurements before and after the run-in period does not exceed 12%;
- •Agrees to follow dietary and lifestyle modification guidance during the trial, maintain a stable diet and exercise routine throughout the study, take medication as required, and complete diary cards;
- •Agrees to participate in this clinical trial and voluntarily signs the informed consent form.
排除标准
- •Known or suspected allergy to any component of the investigational product, or having an allergic constitution.
- •According to the "Chinese Guidelines for Lipid Management (2023)", individuals classified as being at very high risk or extremely high risk for ASCVD.
- •Confirmed homozygous familial hypercholesterolemia.
- •Dyslipidemia caused by secondary reasons, such as nephrotic syndrome, hypothyroidism, renal failure, systemic lupus erythematosus, glycogen storage disease, myeloma, lipodystrophy, acute porphyria, polycystic ovary syndrome, drug-induced causes (e.g., phenothiazines, beta-blockers, glucocorticoids, certain contraceptives, etc.), or patients currently using heparin, thyroid hormone therapy, or other medications that affect lipid metabolism.
- •Any surgical or medical condition that may significantly affect the absorption, distribution, metabolism, or excretion of the drug:
- •History of major gastrointestinal surgery, such as gastrectomy, gastrointestinal anastomosis, or intestinal resection; ② Active or recurrent irritable bowel syndrome (IBS) or inflammatory bowel disease (except for those asymptomatic for at least 6 months prior to the screening visit);
- •Current active gastritis, active ulcer, or gastrointestinal bleeding;
- •History of pancreatic or gallbladder disease (except for those with prior cholecystectomy).
- •Previous use of proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, such as evolocumab and alirocumab.
- •Use of lipid-lowering drugs within 4 weeks prior to enrollment or within 5 half-lives of the drug (whichever is longer), such as statins, cholesterol absorption inhibitors, probucol, bile acid sequestrants, fibrates, niacin, high-purity fish oil preparations, weight-loss drugs (e.g., GLP-1 receptor agonists), and other traditional Chinese medicines, health products, or hospital preparations (e.g., formula granules, herbal decoctions) with clear lipid-lowering effects as stated in the instructions.
- •History of acute or chronic liver disease, drug-induced liver injury, or cirrhosis (except for mild fatty liver indicated by abdominal ultrasound).
- •ALT or AST ≥ 2 times the upper limit of normal (ULN), SCr > ULN, total bilirubin (TBIL) ≥ 1.5 times ULN, creatine kinase ≥ 3 times ULN, or any other laboratory test result (blood routine, urine routine, blood biochemistry) exceeding the ULN, and judged by the investigator as potentially affecting efficacy or safety evaluation.
- •History of any of the following severe cardiovascular or cerebrovascular diseases:
- •① Unstable angina or coronary artery bypass grafting within 3 months prior to the screening visit, or percutaneous coronary intervention.
- •Myocardial infarction, shock, life-threatening arrhythmia, or significant ECG abnormalities (e.g., ST-segment abnormalities, pathological Q waves, abnormal QTc interval, etc.) within 6 months prior to the screening visit.
- •History of left ventricular outflow tract obstruction (e.g., aortic stenosis, idiopathic hypertrophic subaortic stenosis).
- •Heart failure ≥ Class II (NYHA classification) at screening. ⑤ Acute stroke within 6 months prior to the screening visit, excluding asymptomatic stroke.
- •Uncontrolled hypertension (history of hypertension with regular medication, and two consecutive blood pressure measurements ≥ 180/110 mmHg at screening), or history of type 1 diabetes, diabetic ketoacidosis, or uncontrolled type 2 diabetes (HbA1c > 7%).
- •Patients with other severe metabolic diseases.
- •History of myositis, myopathy, or rhabdomyolysis, severe muscle abnormalities, and neuropathy.
- •Thyroid dysfunction (e.g., hyperthyroidism, hypothyroidism, etc.) (except for those judged by the investigator as clinically insignificant).
- •Proven intolerance or inefficacy to HMG-CoA reductase inhibitors.
- •History of malignancy within 5 years prior to the first dose, excluding cervical epithelial carcinoma, squamous cell carcinoma, or basal cell carcinoma of the skin that has been clinically cured for 5 years.
- •Pregnant or lactating women, or individuals of either gender with plans for pregnancy within the next 3 months.
- •Suspected or confirmed history of alcohol, drug, or substance abuse.
- •Individuals with special dietary requirements who cannot adhere to the required diet and exercise control, including but not limited to those following extreme weight-loss diets, undergoing or planning to undergo intense exercise programs (e.g., marathon training, fitness training), or intending to start such training during the trial.
- •Positive for any of the following: hepatitis B virus surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, or syphilis-specific antibody (TPHA).
- •Participation in other interventional clinical trials within the past 3 months.
- •Individuals deemed unsuitable for participation in this clinical trial by the investigator.
研究组 & 干预措施
control group
Active Comparator
干预措施: zhibitai capsule (Drug)
Experimental group
Experimental
干预措施: zhibitai capsule (Drug)
结局指标
主要结局
The percentage and absolute changes in serum low-density lipoprotein cholesterol (LDL-C) from baseline after 4, 8, and 12 weeks of treatment
时间窗: From enrollment to the end of treatment at 4, 8,12 weeks
次要结局
- The proportion of ASCVD low-risk subjects with LDL-C < 3.4 mmol/L after 12 weeks of treatment(From enrollment to the end of treatment at 12 weeks)
- The proportion of ASCVD medium- and high-risk subjects with LDL-C < 2.6 mmol/L after 12 weeks of treatment(From enrollment to the end of treatment at 12 weeks)
研究者
研究点 (13)
Loading locations...
相似试验
进行中（未招募）
2 期
A Study of Xiangjurupining Capsule in the Treatment of Hyperplasia of Breast (Liver Stagnation and Phlegm Coagulation)Hyperplasia of BreastNCT04229706Tasly Pharmaceutical Group Co., Ltd180
已完成
2 期
A Study to Evaluate a Potassium Normalization Treatment Regimen Including Sodium Zirconium Cyclosilicate (ZS) Among Patients With S-K ≥5.8HyperkalemiaNCT03337477AstraZeneca70
招募中
3 期
Efficacy and Safety of Xiangjurupining Capsule for Hyperplasia of Mammary GlandsHyperplasia of Mammary GlandsNCT06685978Tasly Pharmaceutical Group Co., Ltd430
已完成
2 期
A Phase II, Double Blind Study of 2 Doses of ZACTIMA™(ZD6474) in Combination With FOLFIRI vs FOLFIRI Alone for the Treatment of Colorectal Cancer in PatientsColorectal CancerNCT00454116Genzyme, a Sanofi Company106
已完成
1 期
A Two-Part Phase 1 Study to Investigate the Safety and Tolerability of Supratherapeutic Dose of Zanubrutinib and Effect of Zanubrutinib on Cardiac Repolarization in Healthy SubjectsHealthy VolunteersNCT03432884BeiGene40