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

Completed · Phase 2 · Has a placebo group

Conditions studied: Hypercholesterolemia

In brief

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.

Key facts

Study ID

NCT03193047

Run by

Esperion Therapeutics, Inc.

People needed

59

Starts

2017-04-07

Expected to finish

2018-02-19

Last updated by the study team

2020-04-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• L-MARC Research Center — Louisville, Kentucky, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.