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

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ClinicalTrials.gov Identifier: NCT03531905
Recruitment Status : Completed
First Posted : May 22, 2018
Last Update Posted : October 4, 2019
Sponsor:
Information provided by (Responsible Party):
Esperion Therapeutics

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Cholesterolemia Drug: Bempedoic acid + Ezetimibe FDC Oral Tablet Drug: Ezetimibe 10Mg Oral Tablet Drug: Placebo Oral Tablet Drug: Placebo oral capsule Phase 2

Detailed Description:
Assess efficacy of FDC vs. ezetimibe vs. placebo for 12 week LDL-C lowering, changes in atherogenic lipids, hsCRP and exploratory glycemic measures as well as safety in patients with type 2 diabetes and elevated LDL-C.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 242 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Study to Evaluate the Efficacy and Safety of Bempedoic Acid 180 + Ezetimibe 10 Fixed-Dose Combination Compared to Ezetimibe and Placebo In Subjects With T2DM and Elevated LDL-Cholesterol
Actual Study Start Date : May 9, 2018
Actual Primary Completion Date : June 18, 2019
Actual Study Completion Date : June 18, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Ezetimibe

Arm Intervention/treatment
Experimental: Bempedoic acid + Ezetimibe FDC
Bempedoic acid + Ezetimibe FDC Oral Tablet; Placebo oral capsule
Drug: Bempedoic acid + Ezetimibe FDC Oral Tablet
Experimental therapy of bempedoic acid 180 mg + ezetimibe 10 mg FDC tablet

Drug: Placebo oral capsule
Placebo over-encapsulated for blinding purposes

Active Comparator: Ezetimibe 10 mg
Ezetimibe 10Mg Oral Tablet; Placebo Oral Tablet
Drug: Ezetimibe 10Mg Oral Tablet
Ezetimibe 10 mg tablet, overencapsulated for blinding purposes
Other Name: Zetia

Drug: Placebo Oral Tablet
Placebo tablet, matched for the FDC product for blinding purposes

Placebo Comparator: Placebo
Placebo Oral Tablet, Placebo oral capsul
Drug: Placebo Oral Tablet
Placebo tablet, matched for the FDC product for blinding purposes

Drug: Placebo oral capsule
Placebo over-encapsulated for blinding purposes




Primary Outcome Measures :
  1. LDL-C lowering FDC vs. Placebo [ Time Frame: 12 week ]
    Percent change from baseline to week 12 for LDL-C; FDC vs. Placebo

  2. LDL-C lowering FDC vs. Ezetimibe [ Time Frame: 12 week ]
    Percent change from baseline to week 12 for LDL-C; FDC vs. Ezetimibe


Secondary Outcome Measures :
  1. LDL-C lowering Ezetimibe vs. Placebo [ Time Frame: 12 week ]
    Percent change from baseline to week 12 for LDL-C; Ezetimibe vs. Placebo

  2. Change in hs-CRP FDC vs. Ezetimibe [ Time Frame: 12 week ]
    Percent change from baseline to week 12 for hs-CRP; FDC vs. Ezetimibe

  3. Change in hs-CRP FDC vs. Placebo [ Time Frame: 12 week ]
    Percent change from baseline to week 12 for hs-CRP; FDC vs. Placebo

  4. Change in hs-CRP Ezetimibe vs. Placebo [ Time Frame: 12 week ]
    Percent change from baseline to week 12 for hs-CRP; Ezetimibe vs. Placebo

  5. Change in non-HDL-C; FDC vs. Ezetimibe [ Time Frame: 12 week ]
    Percent change from baseline to week 12 for non-HDL-C; FDC vs. Ezetimibe

  6. Change in non-HDL-C; FDC vs. Placebo [ Time Frame: 12 week ]
    Percent change from baseline to week 12 for non-HDL-C; FDC vs. Placebo

  7. Change in non-HDL-C; Ezetimibe vs. Placebo [ Time Frame: 12 week ]
    Percent change from baseline to week 12 for non-HDL-C; Ezetimibe vs. Placebo

  8. Change in apoB; FDC vs. Ezetimibe [ Time Frame: 12 week ]
    Percent change from baseline to week 12 for apoB; FDC vs. Ezetimibe

  9. Change in apoB; FDC vs. Placebo [ Time Frame: 12 week ]
    Percent change from baseline to week 12 for apoB; FDC vs. Placebo

  10. Change in apoB; Ezetimibe vs. Placebo [ Time Frame: 12 week ]
    Percent change from baseline to week 12 for apoB; Ezetimibe vs. Placebo

  11. Change in total cholesterol; FDC vs. Ezetimibe [ Time Frame: 12 week ]
    Percent change from baseline to week 12 for total cholesterol; FDC vs. Ezetimibe

  12. Change in total cholesterol; FDC vs. Placebo [ Time Frame: 12 week ]
    Percent change from baseline to week 12 for total cholesterol; FDC vs. Placebo

  13. Change in total cholesterol; Ezetimibe vs. Placebo [ Time Frame: 12 week ]
    Percent change from baseline to week 12 for total cholesterol; Ezetimibe vs. Placebo


Other Outcome Measures:
  1. Change in hemoglobin A1c; FDC vs. Ezetimibe [ Time Frame: 12 week ]
    Percent change from baseline to week 12 for hemoglobin A1c; FDC vs. Ezetimibe

  2. Change in hemoglobin A1c; FDC vs. Placebo [ Time Frame: 12 week ]
    Percent change from baseline to week 12 for hemoglobin A1c; FDC vs. Placebo

  3. Change in hemoglobin A1c; Ezetimibe vs. Placebo [ Time Frame: 12 week ]
    Percent change from baseline to week 12 for hemoglobin A1c; Ezetimibe vs. Placebo

  4. Change in fasting glucose; FDC vs. Ezetimibe [ Time Frame: 12 week ]
    Percent change from baseline to week 12 for fasting glucose; FDC vs. Ezetimibe

  5. Change in fasting glucose; FDC vs. Placebo [ Time Frame: 12 week ]
    Percent change from baseline to week 12 for fasting glucose; FDC vs. Placebo

  6. Change in fasting glucose; Ezetimibe vs. Placebo [ Time Frame: 12 week ]
    Percent change from baseline to week 12 for fasting glucose; Ezetimibe vs. Placebo

  7. Change in 2-hour postprandial glucose; FDC vs. Ezetimibe [ Time Frame: 12 week ]
    Percent change from baseline to week 12 for 2-hour postprandial glucose; FDC vs. Ezetimibe

  8. Change in 2-hour postprandial glucose; FDC vs. Placebo [ Time Frame: 12 week ]
    Percent change from baseline to week 12 for 2-hour postprandial glucose; FDC vs. Placebo

  9. Change in 2-hour postprandial glucose; Ezetimibe vs. Placebo [ Time Frame: 12 week ]
    Percent change from baseline to week 12 for 2-hour postprandial glucose; Ezetimibe vs. Placebo

  10. Change in HOMA-IR; FDC vs. Ezetimibe [ Time Frame: 12 week ]
    Percent change from baseline to week 12 for HOMA-IR; FDC vs. Ezetimibe

  11. Change in HOMA-IR; FDC vs. Placebo [ Time Frame: 12 week ]
    Percent change from baseline to week 12 for HOMA-IR; FDC vs. Placebo

  12. Change in HOMA-IR; Ezetimibe vs. Placebo [ Time Frame: 12 week ]
    Percent change from baseline to week 12 for HOMA-IR; Ezetimibe vs. Placebo

  13. Treatment-emergent adverse events [ Time Frame: 12 week ]
    Safety and tolerability as measured by rates of treatment-emergent adverse events in each arm



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes for 6 months or greater
  • Currently taking stable diabetes medication for 3 months or greater
  • HbA1c between 7-10%
  • LDL-cholesterol greater than 70 mg/dL
  • Women must not be pregnant, lactating, or planning to become pregnant within 30 days after last dose of study medication; and must be postmenopausal, surgically sterile, or willing to use 1 acceptable form of birth control during the study through 30 days after the last dose of study medication

Exclusion Criteria:

  • Body mass index > 40 kg/m2
  • History of documented clinically significant cardiovascular disease
  • Fasting triglycerides > 400 mg/dL
  • History of Type 1 diabetes
  • Uncontrolled hypothyroidism, liver dysfunction, renal dysfunction, gastrointestinal condition that may affect drug absorption, hematologic or coagulation disorder or active malignancy
  • History of drug or alcohol abuse within 2 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03531905


Locations
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United States, California
Clinical Trials Research
Lincoln, California, United States, 95648
United States, Florida
FInlay Medical Research
Miami, Florida, United States, 33126
United States, Kentucky
L-MARC Research Center
Louisville, Kentucky, United States, 40213
United States, Virginia
Hampton Roads Center for Clinical Research
Suffolk, Virginia, United States, 23435
Sponsors and Collaborators
Esperion Therapeutics
Investigators
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Study Director: JoAnn Flaim, PhD Esperion Therapeutics

Publications:
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Responsible Party: Esperion Therapeutics
ClinicalTrials.gov Identifier: NCT03531905     History of Changes
Other Study ID Numbers: 1002FDC-058
First Posted: May 22, 2018    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Esperion Therapeutics:
diabetes
cholesterolemia
type 2 diabetes
LDL-C
T2D
diabetes mellitus
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid
Ezetimibe
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Enzyme Inhibitors
Hypoglycemic Agents
Physiological Effects of Drugs