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
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
• Female or male, 18-70 years old.
• 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.
• Written informed consent has been obtained during screening visit prior to any study specific procedure.
• 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 .
• Subject must be healthy or stabilized based on medical history and physical examination.
• 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).