Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) 180mg When Added to PCSK9 Inhibitor Therapy

Part of paid clinical trials in Louisville, Kentucky.

Sponsor
Esperion Therapeutics, Inc.
Study ID
NCT03193047
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • bempedoic acid 180mg — DRUG
    Daily bempedoic acid 180mg tablet in addition to monthly PCSK9i (evolocumab) background therapy
  • placebo — OTHER
    Daily matching placebo tablet in addition to monthly PCSK9i (evolocumab) background therapy
  • evolocumab — DRUG
    Monthly PCSK9i (evolocumab) background therapy

Study Details

The purpose of this study is to determine if bempedoic acid (ETC-1002) 180mg added to PCSK9 inhibitor (evolocumab) therapy is effective and safe in patients with elevated LDL cholesterol.

Key Dates

Start date
Apr 7, 2017
Status verified
Mar 2020
Primary completion
Jan 29, 2018
Completion
Feb 19, 2018

Study Design

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

Arms

  • Experimental: bempedoic acid
    Bempedoic acid 180mg tablet taken orally, once daily plus evolocumab (Repatha) 420mg injection once monthly
  • Placebo Comparator: placebo
    Matching placebo tablet taken orally, once daily plus evolocumab (Repatha) 420mg injection once monthly

Primary Outcome Measure

Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C) at Month 2 [ Time Frame: Baseline; Month 2 ]

Locations (1)

FacilityCityStateZIPSite coordinators
L-MARC Research CenterLouisvilleKentucky40213-

Find similar trials in Louisville, KY

By research site
L-MARC Research Center· Louisville, KY

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