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

NCT05683340 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2025-03-13

Study results available
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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

Interventions

DRUG

180mg of ETC-1002(bempedoic acid)

180mg, tablet, once daily, for 12 weeks

DRUG

Placebo

placebo, tablet, once daily, for 12 weeks

Sponsors & Collaborators

  • Otsuka Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Takehisa Matsumaru · Otsuka Pharmaceutical Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-13
Primary Completion
2024-02-20
Completion
2024-03-12

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05683340 on ClinicalTrials.gov