Effectiveness and Safety Study of Early add-on of Ezetimibe With Atorvastatin in Very High-risk Patients

NCT05761444 | Completed Phase 4 Results

• 1 other identifier: OG-KORATO-001
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 7

Brief Summary

This study aims to confirm the effectiveness of ezetimibe add-on therapy on LDL-C levels compared to atorvastatin monotherapy, especially in very high-risk patients. We intend to lay the foundation for a standard treatment for these patients through ezetimibe add on lipid-lowering therapy.

Conditions

Atherosclerotic Cardiovascular Disease

Keywords

Very high-risk patients' Atherosclerotic cardiovascular disease (ASCVD)

Outcome Measures

Primary Outcomes (1)

• Percentage Change From Baseline in Low-Density Lipoprotein Cholesterol at Week 6

  Blood samples were collected to determine the LDL-C values. The percentage change from baseline was defined as 100 x (LDL-C value at 6 weeks - LDL-C value at baseline)/LDL-C value at baseline. Baseline was defined as the last non-missing measurement taken prior to reference start date.

  Baseline (Day 1) and Week 6

Secondary Outcomes (6)

• Percentage of Participants Who Achieved Low-Density Lipoprotein Cholesterol Goal of <55 mg/dL at Weeks 6 and 12

  Weeks 6 and 12

• Percentage of Participants Who Achieved Low-Density Lipoprotein Cholesterol Goal of <70 mg/dL at Weeks 6 and 12

  Weeks 6 and 12

• Percentage Change From Baseline in Low-Density Lipoprotein Cholesterol at Week 12

  Baseline (Day 1) and Week 12

• Percentage Change From Baseline in High-Density Lipoprotein Cholesterol (HDL-C), Non-High-Density Lipoprotein Cholesterol (Non-HDL-C), Triglycerides, and Total Cholesterol at Weeks 6 and 12

  Baseline (Day 1) and Weeks 6 and 12

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) at Weeks 6 and 12

  From the first dose administration of the study treatment (Day 1) up to Week 6; From the first dose administration of the study treatment (Day 1) up to Week 12

Study Arms (2)

Eze/Ato: Ezetimibe/Atorvastatin

EXPERIMENTAL

Participants will receive ezetimibe/atorvastatin 10/40 mg QD from Visit 2 (Day 1) to Visit 3 (Week 6). If the LDL-C target is reached (LDL-C \< 55 mg/dL) at Visit 3, maintain the dose to Visit 4 (Week 12). If the LDL-C target level is not reached at Visit 3, dose is increased to ezetimibe/atorvastatin 10/80 mg QD from Visit 3 to Visit 4.

Drug: Atozet 10/40 mg or 10/80 mg

Ato: Atorvastatin

ACTIVE COMPARATOR

Participants will receive atorvastatin 40 mg QD from Visit 2 (Day 1) to Visit 3 (Week 6). If the LDL-C target is reached (LDL-C \< 55 mg/dL) at Visit 3, maintain the dose to Visit 4 (Week 12). If the LDL-C target is not reached at Visit 3, dose is increased to atorvastatin 80 mg QD from Visit 3 to Visit 4.

Drug: Lipitor 40 mg or 80 mg

Interventions

Atozet 10/40 mg or 10/80 mg DRUG

Atozet 10/40 mg or 10/80 mg Dosage Formulation: Tablet Dosing Instructions: oral. Take 1 tablet daily

Eze/Ato: Ezetimibe/Atorvastatin

Lipitor 40 mg or 80 mg DRUG

Lipitor 40 mg or 80 mg Dosage Formulation: Tablet Dosing Instructions: oral. Take 1 tablet daily

Ato: Atorvastatin

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are ≥ 30 years old.
• Patients with very high-risk\*: clinical or unequivocal on imaging ASCVD. ASCVD includes previous ACS (MI or UA), stable angina, coronary revascularization (percutaneous coronary intervention (PCI), coronary artery bypass graft surgery (CABG), and other arterial revascularization procedures), stroke and transient ischaemic attack (TIA), and peripheral arterial disease (Mach F 2020).
• Patients (a) who failed to achieve their target LDL-C goals with low and/or moderate intensity statin mono therapy for ≥ 4 weeks or (b) who are statin-naïve or have not been on a stable (unchanged) statin regimen for at least 4 weeks prior to enrollment
• rosuvastatin \< 10 mg, atorvastatin \< 40 mg, and all dose of pitavastatin, simvastatin, lovastatin, pravastatin, and fluvastatin (Team G 2020).
• Patients with LDL-C levels ≥ 70 mg/dL
• Patients who are willing to maintain TLC throughout the study.
• Patients who are willing to provide written informed consent prior to study enrollment.

You may not qualify if:

• Patients with hypersensitivity to ezetimibe, atorvastatin or any of its inactive ingredients.
• Patients with active liver disease or unexplained persistent elevations of hepatic transaminase levels. (aspartate transaminase (AST) or alanine transaminase (ALT) \> 3 x upper limit of normal (ULN)).
• Patients who have predisposing conditions with muscle disease (i.e., rhabdomyolysis or myopathy) or neuromuscular disease.
• Patients with myasthenia gravis.
• Female patients who are pregnant or have a potential to be pregnant and nursing.
• Patients who are taking glecaprevir and pibrentasvir.
• Patients with hereditary problems of galactose intolerance, lapp lactase deficiency, or of glucose-galactose malabsorption.
• Patients with disease known to influence serum lipids or lipoproteins excluding dyslipidemia.
• Patients with a history of cancer within 5 years.
• Patients whose life expectancy is less than 6 months due to their medical conditions.
• Patients with any condition or situation that might pose a risk to the participant or interfere with participation in the study.
• Patients who have received any investigational medicine within 12 weeks of written informed consent or are going to receive during the clinical trial period.
• Patients who are judged to be difficult to conduct clinical trials according to the judgment of the investigator.

Sponsors & Collaborators

• Organon and Co: lead
• Iqvia Pty Ltd: collaborator

Study Sites (7)

Eunpyeong St. Mary's Hospital

Seoul, Eunpyeong-gu, 03312, South Korea

Location

Inje University Ilsan-Paik Hospital

Goyang-si, Gyeonggi-do, 10380, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, Gyeongsangbuk-do, 42601, South Korea

Location

Ulsan University Hospital

Ulsan, Gyeongsangnam-do, 44033, South Korea

Location

Chonnam National University Hospital

Gwangju, Jeollanam-do, 61469, South Korea

Location

Kangbuk Samsung Hospital

Seoul, 03181, South Korea

Location

MeSH Terms

Conditions

Atherosclerosis

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Results Point of Contact

• Title: Clinical Lead, Late-Stage Clinical Development
• Organization: Organon Korea Co. Ltd

pdrl@organon.com

551-430-6000

Study Officials

• WonYoung Lee

  Organon

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: March 9, 2023
• Study Start: July 26, 2023
• Primary Completion: September 4, 2024
• Study Completion: October 15, 2024
• Last Updated: September 9, 2025
• Results First Posted: September 9, 2025

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (7)