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

Esperion Therapeutics

Status and phase: Completed; Phase 2

Conditions: Hyperlipidemia

Treatments: Drug: Placebo; Drug: Atorvastatin; Drug: ETC-1002

Study type: Interventional

Funder types: Industry

Identifiers

NCT02659397

1002-035

Details and patient eligibility

About

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.

Enrollment: 68 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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68 participants in 2 patient groups, including a placebo group

ETC-1002 + Atorvastatin

Experimental group

Description:

ETC-1002 180 mg treatment, oral once daily added-on to Atorvastatin 80 mg once daily

Treatment:

Drug: ETC-1002

Drug: Atorvastatin

Placebo + Atorvastatin

Placebo Comparator group

Description:

Placebo treatment, oral once daily added-on to Atorvastatin 80 mg once daily

Treatment:

Drug: Placebo

Drug: Atorvastatin