Actively Recruiting
Zhibitai Capsules for the Treatment of Primary Hyperlipidemia A Randomized, Double-blind, Parallel Controlled, Multicenter, Phase II Clinical Trial
Led by Chengdu Diao Jiuhong Pharmaceutical Factory · Updated on 2025-11-20
192
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the benefits and risks of increasing the dosage of Zhibitai capsules compared to the original dosage for treating primary hyperlipidemia, a condition characterized by high levels of fats in the blood. This randomized, double-blind, parallel controlled, multicenter Phase II clinical trial aims to understand how different dosages affect cholesterol levels and cardiovascular risk factors. Participants will receive either an increased dose of Zhibitai capsules (2 capsules twice daily) or the original dose (1 capsule plus 1 placebo capsule twice daily), taken orally. The study will monitor the effects over 12 weeks, assessing changes in LDL cholesterol and the proportion of patients reaching target LDL levels based on cardiovascular risk. This trial is sponsored by Chengdu Diao Jiuhong Pharmaceutical Factory. During the study, participants will have their LDL cholesterol levels measured at 4, 8, and 12 weeks to track changes from baseline. Researchers will also evaluate how many participants meet specific LDL cholesterol targets after treatment. Participants are expected to follow dietary and lifestyle guidance, maintain diaries, and attend study visits for assessments. The study includes safety monitoring and aims to complete by April 2026.
CONDITIONS
Brief 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 greater than or equal to 3.4 mmol/L and triglyceride (TG) level less than or equal to 4.5 mmol/L
- Diagnosis before and after run-in period meets criteria, with LDL-C difference not exceeding 12%
- Agree to follow dietary and lifestyle guidance, maintain stable diet and exercise, take medication as required, and complete diary cards
- Voluntarily agree to participate and sign informed consent form
You will not qualify if you...
- Known or suspected allergy to any component of the investigational product
- 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, lupus, glycogen storage disease, myeloma, lipodystrophy, acute porphyria, polycystic ovary syndrome, drug-induced causes, or current use of heparin, thyroid hormone therapy, or lipid-altering drugs
- Medical conditions affecting drug absorption or metabolism including major gastrointestinal surgery, active or recurrent IBS or inflammatory bowel disease, active gastritis, ulcers, gastrointestinal bleeding, or history of pancreatic or gallbladder disease (except prior cholecystectomy)
- Previous use of PCSK9 inhibitors like evolocumab or alirocumab
- Use of lipid-lowering drugs within 4 weeks prior to enrollment
- History of acute or chronic liver disease, drug-induced liver injury, cirrhosis (except mild fatty liver)
- Abnormal lab results exceeding safety thresholds (ALT, AST, SCr, TBIL, creatine kinase, etc.)
- Severe cardiovascular or cerebrovascular disease within recent months, including unstable angina, heart attack, significant ECG abnormalities, heart failure class II or above, recent stroke
- Uncontrolled hypertension or uncontrolled diabetes
- Severe metabolic diseases
- History of muscle diseases or neuropathy
- Thyroid dysfunction unless clinically insignificant
- Intolerance or lack of response to HMG-CoA reductase inhibitors
- History of malignancy within 5 years except some cured skin cancers
- Pregnancy, lactation, or plans for pregnancy within 3 months
- History of substance abuse
- Special dietary requirements preventing adherence to study diet and exercise
- Positive for hepatitis B, hepatitis C, HIV, or syphilis
- Participation in other interventional trials within 3 months
- Deemed unsuitable by investigator for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants take Zhibitai capsules orally twice a day as part of the trial treatment for primary hyperlipidemia.
Visits at 4, 8, and 12 weeks during treatment
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
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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