Evaluation and Comparison of the Efficacy and Safety of Statin and Bempedoic Acid Combination Therapy versus Statin Monotherapy

Evaluation and Comparison of the Efficacy and Safety of Statin and Bempedoic Acid Combination Therapy versus Statin Monotherapy in Improving Glycemic Profile and Lipid Profile in Pre-Diabetic Patients: A Randomized Clinical Trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20250131064580N1

Enrollment

Registered

2025-03-02

Start date

2025-04-05

Completion date

Unknown

Last updated

2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: Hypercholesterolemia. Condition 2: Prediabetic.

Interventions

Intervention 1: Intervention group: Pre-diabetic patients suffering from hypercholesterolemia will receive atorvastatin 20 mg along with bempedoic acid 180 mg once a day for 3 months after meeting the

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Prediabetic Age over 18 years Atorvastatin 40 mg indication use

Exclusion criteria

Exclusion criteria: Pregnancy or breastfeeding Gout or hyperuricemia Use of antidiabetic medications Use of corticosteroid medications Kidney failure (eGFR <30 mL/minute/1.73 m²) Liver failure Severe impairment (Child-Pugh class C) Uncontrolled blood pressure Thyroid disorders based on the patient's history Use of pravastatin or simvastatin

Design outcomes

Primary

Measure	Time frame
Lipoprotein (a). Timepoint: Before starting the study and 3 months later. Method of measurement: Laboratory tests.;Apolipoprotein b. Timepoint: Before starting the study and 3 months later. Method of measurement: Laboratory tests.;Total cholesterol. Timepoint: Before starting the study and 3 months later. Method of measurement: Laboratory tests.;LDL. Timepoint: Before starting the study and 3 months later. Method of measurement: Laboratory tests.;HDL. Timepoint: Before starting the study and 3 months later. Method of measurement: Laboratory tests.;Non-HDL cholesterol. Timepoint: Before starting the study and 3 months later. Method of measurement: Laboratory tests.;Triglycerides. Timepoint: Before starting the study and 3 months later. Method of measurement: Laboratory tests.;FBS. Timepoint: Before starting the study and 3 months later. Method of measurement: Laboratory tests.;HbA1c. Timepoint: Before starting the study and 3 months later. Method of measurement: Laboratory tests.;Insulin. Timepoint: Before starting the study and 3 months later. Method of measurement: Laboratory tests.;HOMA-IR. Timepoint: Before starting the study and 3 months later. Method of measurement: Laboratory tests.;Blood urea. Timepoint: Before starting the study and 3 months later. Method of measurement: Laboratory tests.;CBC. Timepoint: Before starting the study and 3 months later. Method of measurement: Laboratory tests.;AST. Timepoint: Before starting the study and 3 months later. Method of measurement: Laboratory tests.;ALT. Timepoint: Before starting the study and 3 months later. Method of measurement: Laboratory tests.;Creatinine Serum. Timepoint: Before starting the study and 3 months later. Method of measurement: Laboratory tests.;EGFR. Timepoint: Before starting the study and 3 months later. Method of measurement: Laboratory tests.	—

Measure

Time frame

Lipoprotein (a). Timepoint: Before starting the study and 3 months later. Method of measurement: Laboratory tests.;Apolipoprotein b. Timepoint: Before starting the study and 3 months later. Method of measurement: Laboratory tests.;Total cholesterol. Timepoint: Before starting the study and 3 months later. Method of measurement: Laboratory tests.;LDL. Timepoint: Before starting the study and 3 months later. Method of measurement: Laboratory tests.;HDL. Timepoint: Before starting the study and 3 months later. Method of measurement: Laboratory tests.;Non-HDL cholesterol. Timepoint: Before starting the study and 3 months later. Method of measurement: Laboratory tests.;Triglycerides. Timepoint: Before starting the study and 3 months later. Method of measurement: Laboratory tests.;FBS. Timepoint: Before starting the study and 3 months later. Method of measurement: Laboratory tests.;HbA1c. Timepoint: Before starting the study and 3 months later. Method of measurement: Laboratory tests.;Insulin. Timepoint: Before starting the study and 3 months later. Method of measurement: Laboratory tests.;HOMA-IR. Timepoint: Before starting the study and 3 months later. Method of measurement: Laboratory tests.;Blood urea. Timepoint: Before starting the study and 3 months later. Method of measurement: Laboratory tests.;CBC. Timepoint: Before starting the study and 3 months later. Method of measurement: Laboratory tests.;AST. Timepoint: Before starting the study and 3 months later. Method of measurement: Laboratory tests.;ALT. Timepoint: Before starting the study and 3 months later. Method of measurement: Laboratory tests.;Creatinine Serum. Timepoint: Before starting the study and 3 months later. Method of measurement: Laboratory tests.;EGFR. Timepoint: Before starting the study and 3 months later. Method of measurement: Laboratory tests.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Aghajani

Shahid Beheshti University of Medical Sciences

dr.aghajani@yahoo.com+98 21 7758 2721

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026