Primary HyperlipidemiaPhase 2NCT06822946
Zhibitai Capsules for the Treatment of Primary Hyperlipidemia
A Phase 2 study testing zhibitai capsule in people with Primary Hyperlipidemia, run by Chengdu Diao Jiuhong Pharmaceutical Factory at 12 sites in China.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Primary Hyperlipidemia
- What is being tested?
- zhibitai capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 12 sitesChina
- Study dates
- 27 Mar 2025to 27 Feb 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
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- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
China12 sites
Affiliated Hospital of Changchun University of Traditional Chinese Medicine
Changchun, Jilin, 130021
Xiangya Second Hospital of Central South University
Changsha, Hunan, 410000
The Fourth Hospital of Changsha
Changsha, Hunan, 410006
Chengdu Second People's Hospital
Chengdu, Sichuan, 610017
Hospital of Chengdu University of TCM
Chengdu, Sichuan, 610072
Guangzhou Guangdong Second Traditional Chinese Medicine Hospital
Guangzhou, Guangdong, 510095
The First Affiliated Hospital of Anhui University of Chinese Medicine
Hefei, Anhui, 230031
Huizhou Central People's Hospital
Huizhou, Guangdong, 516008
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan, 471003
The Affiliated Traditional Chinese Medicine Hospital of Southwest Medical University
Luzhou, Sichuan, 646000
Nanchang People's Hospital
Nanchang, Jiangxi, 330006
Zhengzhou Central Hospital
Zhengzhou, Henan, 450000
About this study
Official title: 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
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
- Being tested
- zhibitai capsule
- Keywords
- zhibitai, primary hyperlipidemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
zhibitai capsuleDrug
2 capsule of Zhibitai capsule/time, 2 times/day, oral
zhibitai capsuleDrug
(1 capsule of Zhibitai capsules+1 capsule of Zhibitai capsule simulant)/time, 2 times/day, oral
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Not described Receives: Drug: zhibitai capsule |
| control group | Active comparator | Not described Receives: Drug: zhibitai capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage and absolute changes in serum low-density lipoprotein cholesterol (LDL-C) from baseline after 4, 8, and 12 weeks of treatment
Measured: 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
Measured: 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
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start27 Mar 2025
- Primary completion9 Feb 2026
- Study completion27 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary HyperlipidemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chengdu Diao Jiuhong Pharmaceutical Factory
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06822946
- Sponsor's protocol ID
- SJTS-20-06-201
- Status last verified
- Sep 2026
- First submitted
- 7 Feb 2025
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06822946
- Acronym / sponsor ID
- SJTS-20-06-201
- Conditions
- Primary Hyperlipidemia
- Keywords
- zhibitai, primary hyperlipidemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Chengdu Diao Jiuhong Pharmaceutical FactoryIndustry (pharma, biotech, devices)
- Study start
- 27 Mar 2025 (actual)
- Primary completion
- 9 Feb 2026 (actual)
- Study completion
- 27 Feb 2026 (actual)
- First posted
- 12 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: zhibitai capsule |
| control group | Active comparator | Drug: zhibitai capsule |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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%;
Key exclusion criteria (29 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| zhibitai capsule2 capsule of Zhibitai capsule/time, 2 times/day, oral | Drug | Experimental group |
| zhibitai capsule(1 capsule of Zhibitai capsules+1 capsule of Zhibitai capsule simulant)/time, 2 times/day, oral | Drug | control group |
Primary outcome
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 weeks
2 secondary outcomes
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 weeks
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 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing zhibitai capsule in people with Primary Hyperlipidemia, run by Chengdu Diao Jiuhong Pharmaceutical Factory at 12 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.