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Completed

NCT Number: NCT05683340

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

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).

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Key information

Conditions

Hyper-low-density Lipoprotein (LDL) Cholesterolemia

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Rinku General Medical Center

Izumisano, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • Other protocol specific inclusion criteria may apply

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
  • Other protocol specific exclusion criteria may apply

Treatment and study plan

180mg of ETC-1002(bempedoic acid)

Drug

180mg, tablet, once daily, for 12 weeks

Placebo

Drug

placebo, tablet, once daily, for 12 weeks

Primary outcomes

  1. Percent Change in LDL-C From Baseline to Week 12

    Time frame: Baseline, week12

    Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100. Baseline was defined as the mean of the values from Week -1 and Day 1.

Secondary outcomes

  1. Percent Change in Non-HDL Cholesterol From Baseline to Week 12

    Time frame: Baseline, week12

    Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100.

  2. Percent Change in Total Cholesterol From Baseline to Week 12

    Time frame: Baseline, week12

    Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100.

  3. Percent Change in Apolipoprotein B From Baseline to Week 12

    Time frame: Baseline, week12

    Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100.

  4. Percent Change in High Sensitivity C Reactive Protein From Baseline to Week 12

    Time frame: Baseline, week12

    Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100.

  5. Percent Change in Hemoglobin A1c From Baseline to Week 12

    Time frame: Baseline, week12

    Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100.

  6. Proportion of Subjects Whose LDL-C Value Achieved the Lipid Management Goals Based on Risk Assessment at Week 12

    Time frame: Baseline, week12

    The proportion of subjects whose LDL-C value achieves the lipid management goal at Week 12.

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Placebo-controlled, Randomized, Multicenter, Double-blind, Parallel-group Trial to Confirm the Superiority of ETC-1002 in Patients With Hyper-LDL Cholesterolemia

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 13, 2023
Registry last updated
Mar 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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