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

Esperion Therapeutics

Status and phase: Completed; Phase 2

Conditions: Hypercholesterolemia

Treatments: Drug: evolocumab; Drug: bempedoic acid 180mg; Other: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03193047

1002-039

Details and patient eligibility

About

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.

Enrollment: 59 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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59 participants in 2 patient groups, including a placebo group

bempedoic acid

Experimental group

Description:

Bempedoic acid 180mg tablet taken orally, once daily plus evolocumab (Repatha) 420mg injection once monthly

Treatment:

Drug: bempedoic acid 180mg

Drug: evolocumab

placebo

Placebo Comparator group

Description:

Matching placebo tablet taken orally, once daily plus evolocumab (Repatha) 420mg injection once monthly

Treatment:

Other: placebo

Drug: evolocumab