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

• Status: Completed
• Trial end date: 2019-06-18
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Esperion Therapeutics; Esperion Therapeutics, Inc.
• Treatments: 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid; Ezetimibe

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