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 |
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
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.
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
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