Actively Recruiting
Zhibitai Capsules for the Treatment of Primary Hyperlipidemia
Led by Chengdu Diao Jiuhong Pharmaceutical Factory · Updated on 2025-11-20
192
Participants Needed
1
Research Sites
57 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
Zhibitai Capsules for the Treatment of Primary Hyperlipidemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years old (inclusive), regardless of gender
- Body Mass Index (BMI) between 18.0 kg/m² and 30.0 kg/m²
- Diagnosed with primary hyperlipidemia (tan yu hu jie, qi xue bu li zheng)
- LDL-C level at or above 3.4 mmol/L and triglycerides (TG) level at or below 4.5 mmol/L
- Diagnosis before and after run-in period meets above criteria with less than 12% difference in LDL-C measurements
- Agree to follow dietary and lifestyle guidance, maintain stable diet and exercise, take medication as required, and complete diary cards
- Willing to participate and sign informed consent form
You will not qualify if you...
- Known or suspected allergy to any component of the investigational product or allergic constitution
- Very high or extremely high risk for ASCVD as per Chinese Guidelines for Lipid Management (2023)
- 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, or current use of heparin, thyroid hormone therapy, or other medications affecting lipid metabolism
- History of major gastrointestinal surgery or active gastrointestinal diseases including IBS or inflammatory bowel disease, active gastritis, ulcer, gastrointestinal bleeding, or pancreatic/gallbladder disease except prior cholecystectomy
- Previous use of PCSK9 inhibitors like evolocumab or alirocumab
- Use of lipid-lowering drugs within 4 weeks before enrollment or within 5 half-lives of such drugs
- History of acute or chronic liver disease, drug-induced liver injury, or cirrhosis except mild fatty liver
- Elevated liver enzymes or other lab abnormalities judged to affect safety or efficacy
- History of severe cardiovascular or cerebrovascular diseases including unstable angina, recent myocardial infarction, life-threatening arrhythmia, heart failure class II or above, or recent stroke
- Uncontrolled hypertension or uncontrolled diabetes
- Other severe metabolic diseases
- History of muscle diseases such as myositis, myopathy, rhabdomyolysis, severe muscle abnormalities, or neuropathy
- Thyroid dysfunction except clinically insignificant cases
- Intolerance or inefficacy to HMG-CoA reductase inhibitors
- Recent history of malignancy within 5 years except certain skin cancers
- Pregnant or lactating women or plans for pregnancy within 3 months
- History of alcohol, drug, or substance abuse
- Special dietary requirements or inability to adhere to diet/exercise control
- Positive for hepatitis B, hepatitis C, HIV, or syphilis
- Participation in other interventional clinical trials within past 3 months
- Deemed unsuitable by investigator for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Xiangya Second Hospital of Central South University
Changsha, Hunan, China, 410000
Actively Recruiting
Research Team
J
Jie Guo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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