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

NCT07405814 | Recruiting

• 1 other identifier: CINARL1118125
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Hyperlipoproteinemia

Outcome Measures

Primary Outcomes (1)

• Absolute mean change in Low-density-lipoprotein-cholesterol levels / mg/dl

  The absolute mean change in fasting Low-Density Lipoprotein Cholesterol (LDL-C) levels from baseline to Week 12.Units: mg/dL,

  from baseline to Week 12

Secondary Outcomes (7)

• Absolute mean changes in Total Cholesterol, High-Density-Lipoprotein-Cholesterol, Non-High-Density-Lipoprotein-Cholesterol and Triglycerides / mg/dl

  from baseline to Week 12

• Absolute mean change in Apolipoprotein-B level / mg/dl

  from baseline to Week 12

• Absolute mean changes in glutamat-oxalacetat-transaminase, glutamate pyruvate transaminase, and gamma-glutamyl transferase levels

  from baseline to Week 12

• Mean change in Fasting plasma glucose levels Unit: mg/dl

  from baseline to Week 12

• Number of Participants With Clinically Significant Physical Examination Abnormalities. Unit: participants

  Week 12

Study Arms (2)

Artisterol

EXPERIMENTAL

Dietary Supplement: investigational product containing phytosterol, artichoke extract and thiamin

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Placebo OTHER

matching placebo administration

Placebo

investigational product containing phytosterol, artichoke extract and thiamin DIETARY_SUPPLEMENT

subjects will take the investigational product once daily

Artisterol

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Pregnant or lactating females
• Specific feeding regimens if not stabilized between screening and baseline, especially those in conflict with study specific Dietary Recommendation.
• Subjects receiving therapies and medications, that may affect lipid levels. If used in the past, washout of 3 months is required.
• Subjects who have a medical condition or history that limits the subject to adhere to the protocol schedule and requirements:
• Known or suspected allergy to the content of investigational product
• 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
• Subjects under a long-term treatment. Subjects stable for 30 days are allowed in the study
• Subjects with a history of acute myocardial infarction (AMI) or severe cardiac conditions
• Subjects with a history of alcoholism, drug and subjects with severe psychotic disorders (stable anti-depressive treatments are allowed)
• Subjects unable to understand and follow the study procedures
• 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).
• Subject with family or hierarchical relationships with the research team members at clinical site.

Sponsors & Collaborators

• Zentiva, k.s.: lead

Study Sites (1)

Polish Mother's memorial Hospital Research Institute

Lodz, 93338, Poland

RECRUITING

MeSH Terms

Conditions

Hyperlipoproteinemias

Interventions

Thiamine

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Central Study Contacts

Marek Ferkl, MD

CONTACT

+420 267 241 111; marek.ferkl@zentiva.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2025
• First Posted: February 12, 2026
• Study Start: April 24, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 12, 2026

Record last verified: 2026-05

Locations

PL (1)