NCT03337308

A Study Evaluating the Safety and Efficacy of Bempedoic Acid Plus Ezetimibe Fixed-Dose Combination Compared to Bempedoic Acid, Ezetimibe, and Placebo in Patients Treated With Maximally Tolerated Statin Therapy

A Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of Bempedoic Acid 180 Mg + Ezetimibe 10 Mg Fixed-Dose Combination Compared to Bempedoic Acid, Ezetimibe, and Placebo Alone in Patients Treated With Maximally Tolerated Statin Therapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 382 (actual)
• Sponsor: Esperion Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if Bempedoic Acid (BA) + Ezetimibe (EZE) in a fixed-dose combination (FDC) is effective and safe versus its individual components and placebo in patients with elevated LDL cholesterol treated with maximally tolerated statin therapy.

Conditions

• Hyperlipidemias

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Bempedoic Acid + Ezetimibe Fixed-Dose Combination	bempedoic acid + ezetimibe FDC 180 mg/10 mg tablet
DRUG	Bempedoic Acid	bempedoic acid 180 mg tablet
DRUG	Ezetimibe	ezetimibe 10 mg overencapsulated tablet
DRUG	Placebos	placebo tablet or capsule to match bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 mg/10 mg tablet, or bempedoic acid 180 mg tablet, or ezetimibe 10 mg capsule

Timeline

• Start date: 2017-10-23
• Primary completion: 2018-06-18
• Completion: 2018-07-18
• First posted: 2017-11-08
• Last updated: 2020-04-08
• Results posted: 2020-04-08

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study