Bempedoic Acid + Ezetimibe Fixed-Dose Combination (FDC) Study in Patients With Type 2 Diabetes and Elevated LDL-C

Part of paid clinical trials in Lincoln, California.

Sponsor
Esperion Therapeutics, Inc.
Study ID
NCT03531905
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Bempedoic acid + Ezetimibe FDC Oral Tablet — DRUG
    Experimental therapy of bempedoic acid 180 mg + ezetimibe 10 mg FDC tablet
  • Ezetimibe 10 mg Oral Tablet — DRUG
    Ezetimibe 10 mg tablet, overencapsulated for blinding purposes
  • Placebo Oral Tablet — DRUG
    Placebo tablet, matched for the FDC product for blinding purposes
  • Placebo oral capsule — DRUG
    Placebo over-encapsulated for blinding purposes

Study Details

12 week study to assess the LDL-C lowering efficacy, other lipid and glycemic measures, and safety of bempedoic acid/ezetimibe FDC compared to ezetimibe and placebo in patients with type 2 diabetes (T2D) and elevated LDL-C

Key Dates

Start date
May 9, 2018
Status verified
Apr 2020
Primary completion
Jun 18, 2019
Completion
Jun 18, 2019

Study Design

Enrollment
242 participants (actual)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Bempedoic acid + Ezetimibe FDC
    Bempedoic acid + Ezetimibe FDC Oral Tablet; Placebo oral capsule
  • Active Comparator: Ezetimibe 10 mg
    Ezetimibe 10Mg Oral Tablet; Placebo Oral Tablet
  • Placebo Comparator: Placebo
    Placebo Oral Tablet, Placebo oral capsule

Primary Outcome Measure

Percent Change From Baseline to Week 12/End of Study (EOS) in Low-density Lipoprotein Cholesterol (LDL-C) [ Time Frame: Baseline; Week 12 ]

Locations (4)

FacilityCityStateZIPSite coordinators
Clinical Trials ResearchLincolnCalifornia95648-
FInlay Medical ResearchMiamiFlorida33126-
L-MARC Research CenterLouisvilleKentucky40213-
Hampton Roads Center for Clinical ResearchSuffolkVirginia23435-

Find similar trials in Lincoln, CA

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Clinical Trials Research· Lincoln, CAFInlay Medical Research· Miami, FLL-MARC Research Center· Louisville, KYHampton Roads Center for Clinical Research· Suffolk, VA

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