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NCT07405814

Clinical Trial On The Effect Of Artisterol On Risk Factors In Individuals With Suboptimal Cholesterol Levels

Sponsor: Zentiva, k.s.

View on ClinicalTrials.gov

Summary

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

Official title: An International, Randomized, Double-Blind, Placebo-Controlled Clinical Trial On The Effect Of Artisterol On Metabolic And Vascular Risk Factors In Individuals With Suboptimal Cholesterol Levels

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

106

Start Date

2026-02-02

Completion Date

2026-10-31

Last Updated

2026-02-12

Healthy Volunteers

Conditions

Hyperlipoproteinemia

Interventions

DIETARY_SUPPLEMENT

investigational product containing phytosterol, artichoke extract and thiamin

subjects will take the investigational product once daily

OTHER

Placebo

matching placebo administration

Inclusion Criteria: 1. Female or male, 18-70 years old. 2. Subjects with mild hypercholesterolemia previously untreated (LDL-C levels between 115 and 160 mg/dL. Note that the upper limit can be extended to 190 mg/dL in case of subject refusing another treatment or intolerant to statins or other lipid lowering therapies. If previously treated, washout of 3 months is required. 3. Written informed consent has been obtained during screening visit prior to any study specific procedure. 4. Subject must understand the informed consent form and other study documents and are willing and able to comply with scheduled visits and requirements of the study protocol, including study specific Dietary Recommendations . 5. Subject must be healthy or stabilized based on medical history and physical examination. 6. Females of childbearing potential must have a negative pregnancy test at screening and agree to use a highly effective form of birth control while on study (from Screening through final study visit). Exclusion Criteria: 1. Pregnant or lactating females 2. Specific feeding regimens if not stabilized between screening and baseline, especially those in conflict with study specific Dietary Recommendation. 3. Subjects receiving therapies and medications, that may affect lipid levels. If used in the past, washout of 3 months is required. 4. Subjects who have a medical condition or history that limits the subject to adhere to the protocol schedule and requirements: 1. Known or suspected allergy to the content of investigational product 2. Previous or ongoing severe medical or laboratory abnormality (acute or chronic) which, in the judgement of the investigator, would make the subject inappropriate for entry into the study 3. Subjects under a long-term treatment. Subjects stable for 30 days are allowed in the study 4. Subjects with a history of acute myocardial infarction (AMI) or severe cardiac conditions 5. Subjects with a history of alcoholism, drug and subjects with severe psychotic disorders (stable anti-depressive treatments are allowed) 6. Subjects unable to understand and follow the study procedures 5. Subjects who are currently participate in another interventional clinical study. Historical participation in a clinical study is allowed with 3 months of washout period (after last IMP dose). 6. Subject with family or hierarchical relationships with the research team members at clinical site.