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



Status:Recruiting
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 75
Updated:2/20/2019
Start Date:May 9, 2018
End Date:July 2019
Contact:Qusai Al-Share, PharmD
Email:clinical@esperion.com
Phone:734-887-3903

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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

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

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.

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
We found this trial at
4
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Louisville, Kentucky 40213
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Lincoln, California 95648
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Miami, Florida 33126
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Suffolk, VA
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