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

Esperion Therapeutics

Status and phase: Completed; Phase 2

Conditions: Cholesterolemia; Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: Bempedoic acid + Ezetimibe FDC Oral Tablet; Drug: Placebo Oral Tablet; Drug: Placebo oral capsule; Drug: Ezetimibe 10 mg Oral Tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT03531905

1002FDC-058

Details and patient eligibility

About

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

Full 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.

Enrollment: 242 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Triple Blind

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242 participants in 3 patient groups, including a placebo group

Bempedoic acid + Ezetimibe FDC

Experimental group

Description:

Bempedoic acid + Ezetimibe FDC Oral Tablet; Placebo oral capsule

Treatment:

Drug: Bempedoic acid + Ezetimibe FDC Oral Tablet

Drug: Placebo oral capsule

Ezetimibe 10 mg

Active Comparator group

Description:

Ezetimibe 10Mg Oral Tablet; Placebo Oral Tablet

Treatment:

Drug: Ezetimibe 10 mg Oral Tablet

Drug: Placebo Oral Tablet

Placebo

Placebo Comparator group

Description:

Placebo Oral Tablet, Placebo oral capsule

Treatment:

Drug: Placebo Oral Tablet

Drug: Placebo oral capsule