HyperlipidemiaPhase 2/3NCT06782646
Study on the Sex-specific, Lipid- and Lipoprotein-lowering Effects of Berberine
A Phase 2/3 study testing Berberine in people with Hyperlipidemia, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
The goal of this clinical trial is to learn if berberine works to affect lipids and lipoproteins in Chinese females aged 20 to 65 years with hyperlipidaemia. The goal also includes to examine the sex-specific effect of berberine on lipids and lipoproteins. Read more about this study
- Who is it for?
- Ages 20 to 65 years, women only
- Conditions the study is for
- Hyperlipidemia
- What is being tested?
- Berberine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Aug 2024to Mar 2026
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 20 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women, who are:
- aged 20 to 65 years.
- of Chinese ethnicity.
- with hyperlipidemia, defined as TG greater than 150 mg/dl (1.70 mmol/L), total cholesterol greater than 200 mg/dl (5.16 mmol/L), and/or LDL-cholesterol greater than 100 mg/dl (2.58 mmol/L).
- willing to make return visits.
- not currently receiving hormone replacement therapy or medications/pills containing hormones (such as hormonal contraception or hormone replacement therapy) in the past 12 months.
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- not currently taking berberine or nutraceuticals that contain berberine.
- free of any congenital diseases, including familial hypercholesterolemia.
- free of Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency. G6PD will be tested using G6PD rapid diagnostic tests.
- free of hemolytic anemia.
- free of any infectious diseases, e.g., seasonal influenza.
- without liver/renal diseases.
- not pregnant or planning to get pregnant in the next three months. Pregnancy will be ruled out using HCG ULTRA pregnancy tests.
- not currently breastfeeding.
Who cannot join
- All men, and women who did not meet the aforementioned inclusion criteria and/or were unable or unwilling to provide consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site
School of Public Health, The University of Hong Kong
Hong Kong
About this study
Official title: Assessing the Sex-specific, Lipid- and Lipoprotein-lowering Effects of Berberine Using Randomized, Placebo-controlled, Double-masked Trial
The goal of this clinical trial is to learn if berberine works to affect lipids and lipoproteins in Chinese females aged 20 to 65 years with hyperlipidaemia. The goal also includes to examine the sex-specific effect of berberine on lipids and lipoproteins. Our previous HMRF-funded randomized trial in men and prior evidence suggests berberine affects sex hormones. Given the different sex hormone profiles in men and women, the main question it aims to answer is:
- Does berberine have sex-specific lipid-modifying effects? Researchers will compare berberine to a placebo (a look-alike substance that contains no drug) to see if berberine works to affect lipids and lipoproteins.
Read more
Participants will:
- Take a baseline questionnaire
- Take berberine or a placebo every day for 12 weeks
- Take follow-up visits after 8 weeks and 12 weeks for blood sample collections and tests
Read the detailed description
The overall aim of the project is to assess the sex-specific effects of berberine on lipids, apoA1, apoB, and Lp(a). Specifically, the objectives of the project are to 1) assess the effect of berberine on lipids (total cholesterol, LDL-cholesterol, HDL-cholesterol, non-HDL cholesterol, and TG), lipoproteins (apoA1, apoB, and Lp(a)) and sex hormones by conducting a randomized, parallel, double-masked, placebo-controlled trial of berberine RCT in women; 2) assess the effect of berberine on apoA1, apoB, Lp(a) and sex hormone binding globulin (SHBG) in men using stored samples from our completed RCT of berberine in men; 3) assess whether the effects of berberine on lipids, lipoproteins and sex hormones differ in men and women.
This is a randomized, parallel, double-blinded, placebo-controlled trial of berberine in 100 Chinese women with hyperlipidemia in Hong Kong.
Participants will be randomized to two arms in which half of the participants will receive berberine (500 mg orally twice a day) and the other half will receive placebos (500 mg orally twice a day) for 12 weeks. Blood samples will be taken at baseline, 8-week and 12-week intervention.
The investigators will use an intention-to-treat analysis. Changes in lipids and lipoproteins after 8- and 12-week treatment will be assessed using analysis of variance and generalized estimating equation (GEE) model accounting for measurements at both time points.
- Conditions
- Hyperlipidemia
- Being tested
- Berberine, Placebo
- Keywords
- Hyperlipidemia, berberine, lipoprotein, lipid, sex-hormones, apoA1, apoB, Lp(a)
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BerberineDrug
Also called Berberine (500 mg orally twice a day)
Participants will take purified berberine (500 mg orally twice a day) for 12 weeks.
PlaceboDrug
Also called Placebo (500 mg orally twice a day)
Participants will take placebo tablets, a look-alike substance that contains no drug, (500 mg orally twice a day) for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Berberine Group | Experimental | berberine (500 mg orally twice a day) Receives: Drug: Berberine |
| Placebo Group | Placebo comparator | placebo (500 mg orally twice a day) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total cholesterol in mmol/L
Total cholesterol, LDL-cholesterol, TG, apoB, and Lp(a), which are causal factors for coronary heart disease.
Measured: 4 months for biomarker assessment, 6 months for data analysis
LDL-cholesterol in mmol/L
Total cholesterol, LDL-cholesterol, TG, apoB, and Lp(a), which are causal factors for coronary heart disease.
Measured: 4 months for biomarker assessment, 6 months for data analysis
Triglycerides in mmol/L
Total cholesterol, LDL-cholesterol, TG, apoB, and Lp(a), which are causal factors for coronary heart disease.
Measured: 4 months for biomarker assessment, 6 months for data analysis
Apolipoprotein B in mg/dL
Total cholesterol, LDL-cholesterol, TG, apoB, and Lp(a), which are causal factors for coronary heart disease.
Measured: 4 months for biomarker assessment, 6 months for data analysis
Lipoprotein (a) in mg/dL
Total cholesterol, LDL-cholesterol, TG, apoB, and Lp(a), which are causal factors for coronary heart disease.
Measured: 4 months for biomarker assessment, 6 months for data analysis
Secondary outcomes (6)
HDL-cholesterol in mmol/L
Other relevant lipids and lipoproteins.
Measured: 4 months for biomarker assessment, 6 months for data analysis
Non-HDL-cholesterol in mmol/L
Other relevant lipids and lipoproteins.as liver and kidney function.
Measured: 4 months for biomarker assessment, 6 months for data analysis
Apolipoprotein A1 in mg/dL
Other relevant lipids and lipoproteins.
Measured: 4 months for biomarker assessment, 6 months for data analysis
Estradiol (E2) in pg/mL
Examine the sex-specific effects of berberine on apoA1, apoB, Lp(a) and lipids
Measured: 4 months for biomarker assessment, 6 months for data analysis
Sex hormone binding globulin (SHBG) in nmol/L
Examine the sex-specific effects of berberine on apoA1, apoB, Lp(a) and lipids
Measured: 4 months for biomarker assessment, 6 months for data analysis
Testosterone in ng/dL
Examine the sex-specific effects of berberine on apoA1, apoB, Lp(a) and lipids
Measured: 4 months for biomarker assessment, 6 months for data analysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start1 Aug 2024
- Primary completionDec 2025 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipidemiaStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Jie Zhao, The University of Hong Kong
- Investigators
- Jie Zhao, Dr, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06782646
- Sponsor's protocol ID
- 21222191
- Status last verified
- Jan 2025
- First submitted
- 10 Jan 2025
- Last updated
- 20 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Sex-specific, Lipid- and Lipoprotein-lowering Effects of Berberine Using Randomized, Placebo-controlled, Double-masked Trial
- ClinicalTrials.gov ID
- NCT06782646
- Acronym / sponsor ID
- 21222191
- Conditions
- Hyperlipidemia
- Keywords
- Hyperlipidemia, berberine, lipoprotein, lipid, sex-hormones, apoA1, apoB, Lp(a)
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 20 Jan 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.
The goal of this clinical trial is to learn if berberine works to affect lipids and lipoproteins in Chinese females aged 20 to 65 years with hyperlipidaemia. The goal also includes to examine the sex-specific effect of berberine on lipids and lipoproteins. Our previous HMRF-funded randomized trial in men and prior evidence suggests berberine affects sex hormones. Given the different sex hormone profiles in men and women, the main question it aims to answer is:
- Does berberine have sex-specific lipid-modifying effects? Researchers will compare berberine to a placebo (a look-alike substance that contains no drug) to see if berberine works to affect lipids and lipoproteins.
Participants will:
- Take a baseline questionnaire
- Take berberine or a placebo every day for 12 weeks
- Take follow-up visits after 8 weeks and 12 weeks for blood sample collections and tests
Detailed description
The overall aim of the project is to assess the sex-specific effects of berberine on lipids, apoA1, apoB, and Lp(a). Specifically, the objectives of the project are to 1) assess the effect of berberine on lipids (total cholesterol, LDL-cholesterol, HDL-cholesterol, non-HDL cholesterol, and TG), lipoproteins (apoA1, apoB, and Lp(a)) and sex hormones by conducting a randomized, parallel, double-masked, placebo-controlled trial of berberine RCT in women; 2) assess the effect of berberine on apoA1, apoB, Lp(a) and sex hormone binding globulin (SHBG) in men using stored samples from our completed RCT of berberine in men; 3) assess whether the effects of berberine on lipids, lipoproteins and sex hormones differ in men and women.
This is a randomized, parallel, double-blinded, placebo-controlled trial of berberine in 100 Chinese women with hyperlipidemia in Hong Kong.
Participants will be randomized to two arms in which half of the participants will receive berberine (500 mg orally twice a day) and the other half will receive placebos (500 mg orally twice a day) for 12 weeks. Blood samples will be taken at baseline, 8-week and 12-week intervention.
The investigators will use an intention-to-treat analysis. Changes in lipids and lipoproteins after 8- and 12-week treatment will be assessed using analysis of variance and generalized estimating equation (GEE) model accounting for measurements at both time points.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Berberine Group | Experimental | Drug: Berberineberberine (500 mg orally twice a day) |
| Placebo Group | Placebo comparator | Drug: Placeboplacebo (500 mg orally twice a day) |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Women, who are:
Key exclusion criteria (1 listed)
- All men, and women who did not meet the aforementioned inclusion criteria and/or were unable or unwilling to provide consent.
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 |
|---|---|---|
| BerberineAlso: Berberine (500 mg orally twice a day)Participants will take purified berberine (500 mg orally twice a day) for 12 weeks. | Drug | Berberine Group |
| PlaceboAlso: Placebo (500 mg orally twice a day)Participants will take placebo tablets, a look-alike substance that contains no drug, (500 mg orally twice a day) for 12 weeks. | Drug | Placebo Group |
Primary outcome
Total cholesterol in mmol/L
Time frame: 4 months for biomarker assessment, 6 months for data analysis
Total cholesterol, LDL-cholesterol, TG, apoB, and Lp(a), which are causal factors for coronary heart disease.
LDL-cholesterol in mmol/L
Time frame: 4 months for biomarker assessment, 6 months for data analysis
Total cholesterol, LDL-cholesterol, TG, apoB, and Lp(a), which are causal factors for coronary heart disease.
Triglycerides in mmol/L
Time frame: 4 months for biomarker assessment, 6 months for data analysis
Total cholesterol, LDL-cholesterol, TG, apoB, and Lp(a), which are causal factors for coronary heart disease.
Apolipoprotein B in mg/dL
Time frame: 4 months for biomarker assessment, 6 months for data analysis
Total cholesterol, LDL-cholesterol, TG, apoB, and Lp(a), which are causal factors for coronary heart disease.
Lipoprotein (a) in mg/dL
Time frame: 4 months for biomarker assessment, 6 months for data analysis
Total cholesterol, LDL-cholesterol, TG, apoB, and Lp(a), which are causal factors for coronary heart disease.
6 secondary outcomes
HDL-cholesterol in mmol/L
Time frame: 4 months for biomarker assessment, 6 months for data analysis
Non-HDL-cholesterol in mmol/L
Time frame: 4 months for biomarker assessment, 6 months for data analysis
Apolipoprotein A1 in mg/dL
Time frame: 4 months for biomarker assessment, 6 months for data analysis
Estradiol (E2) in pg/mL
Time frame: 4 months for biomarker assessment, 6 months for data analysis
Sex hormone binding globulin (SHBG) in nmol/L
Time frame: 4 months for biomarker assessment, 6 months for data analysis
Testosterone in ng/dL
Time frame: 4 months for biomarker assessment, 6 months for data analysis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
Jie Zhao, Dr principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Berberine in people with Hyperlipidemia, run by The University of Hong Kong at 1 site in Hong Kong.
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 14 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 20 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Total cholesterol in mmol/L (time frame: 4 months for biomarker assessment, 6 months for data analysis). The study lists 5 primary outcomes in all. 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 20 Jan 2025; AzTrials last refreshed its copy on 6 Nov 2026.