Zhibitai Capsules for the Treatment of Primary Hyperlipidemia

NCT06822946 | Recruiting Phase 2

• 1 other identifier: SJTS-20-06-201
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

Brief Summary

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

Primary Hyperlipidemia

Keywords

zhibitai; primary hyperlipidemia

Outcome Measures

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

  From enrollment to the end of treatment at 4, 8,12 weeks

Secondary Outcomes (2)

• 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

Other Outcomes (6)

• The percentage and absolute changes in total cholesterol (TC) from baseline after 4, 8, and 12 weeks of treatment

  From enrollment to the end of treatment at 4,8,12 weeks

• The percentage and absolute changes in triglycerides (TG) from baseline after 4, 8, and 12 weeks of treatment

  From enrollment to the end of treatment at 4,8,12 weeks

• 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

  From enrollment to the end of treatment at 4,8,12 weeks

Study Arms (2)

Experimental group

EXPERIMENTAL

Drug: zhibitai capsule

control group

ACTIVE COMPARATOR

Drug: zhibitai capsule

Interventions

zhibitai capsule DRUG

2 capsule of Zhibitai capsule/time, 2 times/day, oral

Experimental group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chengdu Diao Jiuhong Pharmaceutical Factory: lead

Study Sites (1)

Xiangya Second Hospital of Central South University

Changsha, Hunan, 410000, China

RECRUITING

MeSH Terms

Interventions

zhibitai

Central Study Contacts

Jie Guo

CONTACT

+86 028-82900562; guojie@rnd.diao.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 12, 2025
• Study Start: March 27, 2025
• Primary Completion: February 28, 2026
• Study Completion: April 30, 2026
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)