Actively Recruiting
Clinical Trial On The Effect Of Artisterol On Risk Factors In Individuals With Suboptimal Cholesterol Levels
Led by Zentiva, k.s. · Updated on 2026-05-12
106
Participants Needed
1
Research Sites
35 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn if Artisterol works to lower LDL cholesterol and other metabolic and vascular risk factors in adults. The main questions it aims to answer are: • Does Artisterol lower low-density lipoprotein cholesterol (LDL-C) levels in participants and by how much? Researchers will compare Artisterol to a placebo (a look-alike substance that contains no drug) to see if Artisterol works to lower LDL cholesterol. Participants will: * Take drug Artisterol or a placebo every day for 3 months * Visit the clinic once every 6 weeks for checkups and tests * Keep a diary of their Artisterol intake and physical activity
CONDITIONS
Official Title
Clinical Trial On The Effect Of Artisterol On Risk Factors In Individuals With Suboptimal Cholesterol Levels
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female or male, 18-70 years old
- Mild hypercholesterolemia untreated or with 3-month washout (LDL-C 115-160 mg/dL or up to 190 mg/dL if statin intolerant)
- Signed informed consent before any study procedure
- Understand and willing to comply with study visits and dietary recommendations
- Healthy or medically stable based on history and exam
- Females of childbearing potential with negative pregnancy test and agreeing to use effective birth control during study
You will not qualify if you...
- Pregnant or breastfeeding females
- Unstable feeding regimens conflicting with study diet
- Using therapies or medications affecting lipids without 3-month washout
- Allergy to investigational product ingredients
- Severe medical or lab abnormalities making participation inappropriate
- Long-term treatments unstable within 30 days
- History of severe cardiac conditions or acute myocardial infarction
- History of alcoholism, drug abuse, or severe psychotic disorders
- Unable to understand or follow study procedures
- Participating in another interventional clinical study or within 3 months washout
- Family or hierarchical relationships with study research team members at site
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Polish Mother's memorial Hospital Research Institute
Lodz, Poland, 93338
Actively Recruiting
Research Team
M
Marek Ferkl, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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