A Dose-finding Trial of ETC-1002(Bempedoic Acid) in Patients With Hypercholesterolemia

Sponsor
Otsuka Pharmaceutical Co., Ltd.
Study ID
NCT04784442
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - 74 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The purpose of this study is to assess the low-density lipoprotein cholesterol (LDL-C)-lowering efficacy and safety of ETC-1002(bempedoic acid) 60 mg, 120 mg and 180 mg versus placebo added to ongoing stable statin therapy or other lipid-modifying therapies in Japanese patients with hypercholesterolemia treated for 12 weeks.

Key Dates

Start date
Mar 24, 2021
Status verified
May 2024
Primary completion
Apr 18, 2022
Completion
May 17, 2022

Study Design

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

Arms

  • Experimental: ETC-1002 180mg
  • Experimental: ETC-1002 120mg
  • Experimental: ETC-1002 60mg
  • Placebo Comparator: Placebo

Primary Outcome Measure

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

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