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

Sponsor: Otsuka Pharmaceutical Co., Ltd.
Study ID: NCT05683340
Phase: PHASE3
Status: Completed

Conditions

Hyper-low-density Lipoprotein (LDL) Cholesterolemia

Eligibility Criteria

Sex: ALL
Age: 18 Years - 85 Years
Healthy Volunteers: Not accepted

Interventions

180mg of ETC-1002(bempedoic acid) — DRUG
180mg, tablet, once daily, for 12 weeks
Placebo — DRUG
placebo, tablet, once daily, for 12 weeks

Study Details

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).

Key Dates

Start date: Feb 13, 2023
Status verified: Mar 2025
Primary completion: Feb 20, 2024
Completion: Mar 12, 2024

Study Design

Enrollment: 96 participants (actual)
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Arms

Experimental: ETC-1002 180mg
Placebo Comparator: Placebo

Primary Outcome Measure

Percent Change in LDL-C From Baseline to Week 12 [ Time Frame: Baseline, week12 ]