A Study Of Pharmacokinetics, Pharmacodynamics And Safety Of Adding ETC-1002 To Atorvastatin 80 mg

Esperion Therapeutics, Inc.68 enrolled

Overview

The purpose of this research study is to measure the amount of atorvastatin and ETC-1002 in the blood, to determine how ETC-1002 affects the level of LDL-cholesterol (bad cholesterol) and other markers of health and disease in blood and urine, and to see how ETC-1002 is tolerated in the body compared to placebo when added to stable atorvastatin 80 mg background therapy in statin-treated patients.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Hyperlipidemia

Interventions

ETC-1002DRUG

Blinded ETC-1002 180 mg tablet once daily for 4 weeks (Weeks 1 to 4)

AtorvastatinDRUG

Atorvastatin 80 mg tablet once daily for 8 weeks (Weeks -4 to 4)

PlaceboDRUG

Blinded ETC-1002-matched placebo tablet once daily for 4 weeks (Weeks 1 to 4)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Taking daily stable statin doses for at least 4 weeks prior to screening visit. * LDL-C between 100-220 mg/dL for patients taking daily high-intensity statin (for 4 weeks prior to switching to sponsor -provided atorvastatin 80 mg/day and stopping all other lipid-regulating drugs and supplements) at the screening visit; or, * LDL-C between 115-220 mg/dL for patients taking moderate- or low-intensity statin (for 4 weeks prior to switching to sponsor -provided atorvastatin 80 mg/day and stopping all other lipid-regulating drugs and supplements) at the screening visit. * Must be willing to discontinue other lipid-regulating therapies during the study Exclusion Criteria: * History of acute significant cardiovascular disease. * Current clinically significant cardiovascular disease. * History of inability to tolerate any statin at any dose due to muscle-related pain or weakness.

Locations (19)

Unnamed facility

Anaheim, California, United States

Unnamed facility

Los Angeles, California, United States

Unnamed facility

Northridge, California, United States

Outcomes

Primary Outcomes

Peak plasma concentration (Cmax) pharmacokinetics of atorvastatin and its active metabolites

Fold change in Cmax from prior-to to following 2 week treatment with ETC-1002

Time frame: 2 weeks

24-hour area under the curve (AUC) pharmacokinetics of atorvastatin and its active metabolites

Fold change in AUC from prior-to to following 2 week treatment with ETC-1002

Time frame: 2 weeks

Percent change in LDL-cholesterol

Percent Change from baseline to 4 week treatment, incremental lowering of LDL-C

Time frame: 4 weeks

Secondary Outcomes

Percent change in hsCRP

Percent change from baseline to following 4 week treatment with ETC-1002

Time frame: 4 weeks

Percent change in total cholesterol

Percent change from baseline to following 4 week treatment with ETC-1002

Time frame: 4 weeks

Percent change in non-HDL-cholesterol

Percent change from baseline to following 4 week treatment with ETC-1002

Time frame: 4 weeks

Percent change in apolipoprotein B

Percent change from baseline to following 4 week treatment with ETC-1002

Time frame: 4 weeks

24-hour post dose plasma concentration pharmacokinetics of ETC-1002 and its active metabolite

Fold change in trough exposure from prior-to to following 2 week treatment with ETC-1002

Data from ClinicalTrials.gov

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