Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) 180mg When Added to PCSK9 Inhibitor Therapy

• Status: Completed
• Trial end date: 2018-02-19
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if bempedoic acid (ETC-1002) 180mg added to PCSK9 inhibitor (evolocumab) therapy is effective and safe in patients with elevated LDL cholesterol.

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

Details

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

Criteria

Inclusion Criteria:

• Age ≥18 years or legal age of majority depending on regional law

• Fasting, calculated LDL-C at screening ≥160 mg/dL and following PCSK9i therapy ≥70 mg/dL

• Men and nonpregnant, nonlactating women

Exclusion Criteria:

• Heterozygous (HeFH) or Homozygous (HoFH) Familial Hypercholesterolemia

• Total fasting TG ≥500 mg/dL

• Renal dysfunction or a glomerulonephropathy; eGFR <30 mL/min/1.73 m2

• Known cardiovascular disease (CVD), peripheral arterial disease (PAD), or cerebrovascular disease (CD)

• History of type 1 or type 2 diabetes

• Uncontrolled hypertension

• Uncontrolled hypothyroidism

• Liver disease or dysfunction

• Gastrointestinal conditions or procedures (including Lap-Band® or gastric bypass)

• History of hematologic or coagulation disorders

• History of malignancy (except non-metastatic basal or squamous cell carcinoma of the skin and cervical carcinoma in situ)

• Unexplained creatine kinase (CK) >3 × ULN

• Use of a cholesterylester transfer protein (CETP) inhibitor in the last 12 months prior to screening, such as: anacetrapib, dalcetrapib, or evacetrapib

• Pregnant or breast feeding, or planning to become pregnant during treatment and/ or within 30 days after the end of treatment