A Confirmatory Trial of ETC-1002 in Patients With Hyper-LDL Cholesterolemia

NCT ID: NCT05683340

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-13
• Study Completion Date: 2024-03-12

Brief Summary

The purpose of this study is to confirm the superiority of ETC-1002 after 12 weeks of administration at 180 mg/day to placebo in patients with hyper-LDL cholesterolemia who have inadequate control of low-density lipoprotein cholesterol (LDL C).

Conditions

Hyper-low-density Lipoprotein (LDL) Cholesterolemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

ETC-1002 180mg

Group Type: EXPERIMENTAL

180mg of ETC-1002(bempedoic acid)

Intervention Type: DRUG

180mg, tablet, once daily, for 12 weeks

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

placebo, tablet, once daily, for 12 weeks

Interventions

180mg of ETC-1002(bempedoic acid)

180mg, tablet, once daily, for 12 weeks

Intervention Type: DRUG

Placebo

placebo, tablet, once daily, for 12 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients with inadequate response to statins or statin intolerance as defined below [Inadequate response to statins] Patients with hyper-LDL cholesterolemia who have been taking statins[and other lipid-modifying therapies(LMTs) if needed] and cannot achieve the lipid management goals of LDL-C [Statin intolerance] Patients with hyper-LDL cholesterolemia for whom safety problems have occurred while taking at least one type of statin, and who experienced resolution of the problems after discontinuation or dose reduction, and who cannot achieve the lipid management goals of LDL-C. Patients must be on the lowest or under the dosage of the approved dose of statin and/or on stable LMT(s).
• Patients with fasting TG levels of <400 mg/dL at screening

Exclusion Criteria

• Females who are pregnant or breast-feeding or who have a positive pregnancy test (urine) result at screening or baseline visits
• Patients with homozygous familial hypercholesterolemia (HoFH)
• Patients who currently have or who have had within the past 3 months prior to screening any cardiovascular diseases, or those who have developed any cardiovascular diseases during the screening or before baseline visit
• Uncontrolled hypertension, defined as sitting systolic blood pressure after resting 5 minutes of ≥160 mmHg or diastolic blood pressure of ≥100 mmHg at screening
• Patients with uncontrolled and serious hematologic or coagulation disorders or with hemoglobin of <10.0 g/dL at screening
• Patients with uncontrolled diabetes with HbA1c of ≥9% at screening
• Patients with uncontrolled hypothyroidism with thyroid-stimulating hormone (TSH) of >1.5 × ULN at screening
• Patients with liver disease or dysfunction, including:

• Positive serology for hepatitis B surface antigen (HBsAg) or a positive hepatitis C virus (HCV) antibody test at screening
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) of ≥3 × ULN or total bilirubin of ≥2 × ULN at screening
• Patients with creatine kinase (CK) of >3 × ULN at screening
• Patients with a history or current renal dysfunction, nephritic syndrome, or nephritis, and with estimated glomerular filtration rate (eGFR) of ≤30 mL/min/1.73 m2 at screening

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Takehisa Matsumaru

Role: STUDY_DIRECTOR

Otsuka Pharmaceutical Co., Ltd.

Locations

Rinku General Medical Center

Izumisano, , Japan

Countries

Japan

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

346-102-00002

Identifier Type: -

Identifier Source: org_study_id