Zhibitai Capsules for the Treatment of Primary Hyperlipidemia
ConditionPrimary Hyperlipidemia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChengdu Diao Jiuhong Pharmaceutical Factory
About this trial
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)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
zhibitai capsule
Drug2 capsule of Zhibitai capsule/time, 2 times/day, oral
zhibitai capsule
Drug(1 capsule of Zhibitai capsules+1 capsule of Zhibitai capsule simulant)/time, 2 times/day, oral
Treatment groups
192 Participants
are divided into 2 treatment groupsGroup A: Experimental groupExperimental treatment 1 intervention
Group B: control groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
The percentage and absolute changes in serum low-density lipoprotein cholesterol (LDL-C) from baseline after 4, 8, and 12 weeks of treatment
Time frame
From enrollment to the end of treatment at 4, 8,12 weeksSecondary outcomes
1
The proportion of ASCVD low-risk subjects with LDL-C < 3.4 mmol/L after 12 weeks of treatment
Time frame
From enrollment to the end of treatment at 12 weeks2
The proportion of ASCVD medium- and high-risk subjects with LDL-C < 2.6 mmol/L after 12 weeks of treatment
Time frame
From enrollment to the end of treatment at 12 weeksOther outcomes
1
The percentage and absolute changes in total cholesterol (TC) from baseline after 4, 8, and 12 weeks of treatment
Time frame
From enrollment to the end of treatment at 4,8,12 weeks2
The percentage and absolute changes in triglycerides (TG) from baseline after 4, 8, and 12 weeks of treatment
Time frame
From enrollment to the end of treatment at 4,8,12 weeks3
The percentage and absolute changes in high-density lipoprotein cholesterol (HDL-C) and non-HDL-C from baseline after 4, 8, and 12 weeks of treatment
Time frame
From enrollment to the end of treatment at 4,8,12 weeks4
The percentage and absolute changes in Apo A1 and Apo B from baseline after 4, 8, and 12 weeks of treatment
Time frame
From enrollment to the end of treatment at 4,8,12 weeksSponsors and contacts
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Source ClinicalTrials.gov