Evaluation of ETC-1002, Ezetimibe, and the Combination in Hypercholesterolemic Patients

Phase 2

Completed

• Conditions: Hypercholesterolemia
• Interventions: Drug: ETC-1002; Drug: Ezetimibe

• Registration Number: NCT01941836
• Lead Sponsor: Esperion Therapeutics, Inc.

Brief Summary

The purpose of this research study is to see how ETC-1002 is tolerated in the body, to measure the amount of ETC-1002 in the blood, and to determine how ETC-1002 affects the level of LDL-cholesterol (bad cholesterol) and other markers of health and disease in blood and urine in patients with elevated LDL-cholesterol with or without statin intolerance.

Detailed Description

Hypercholesterolemic patients either with or without a history of statin intolerance (1:1 ratio) will be randomized to receive once daily by mouth capsules containing either ETC-1002, ezetimibe, or ETC-1002 + ezetimibe. This study will explore the safety and efficacy of concomitant administration of ETC-1002 and ezetimibe, while also exploring the effect of ezetimibe on ETC-1002 systemic exposure.

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-09-06
• Study First Submitted QC: 2013-09-10
• Study First Posted: 2013-09-13
• Primary Completion: 2014-10
• Study Completion: 2014-11
• Disposition First Submitted: 2015-08-13
• Disposition First Submitted QC: 2015-08-27
• Disposition First Posted: 2015-09-11
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-26
• Last Update Posted: 2019-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 349

Inclusion Criteria

• Statin intolerant and statin tolerant
• Fasting LDL-C between 130 mg/dL and 220 mg/dL
• Fasting triglyceride less than or equal to 400 mg/dL
• Body mass index (BMI) between 18 and 45 kg/m2

Key

Exclusion Criteria

• History or current clinically significant cardiovascular disease
• History or current type 1 diabetes or uncontrolled type 2 diabetes
• Use of metformin or thiazolidinediones (TZD) within 3 months of screening
• History of joint symptoms difficult to differentiate from myalgia
• Uncontrolled hypothyroidism
• Liver disease or dysfunction
• Renal dysfunction or nephritic syndrome
• Gastrointestinal (GI) conditions or prior GI procedures
• HIV or AIDS
• History or malignancy
• History or drug or alcohol abuse within last 2 years
• Use of experimental or investigational drugs within 30 days of screening
• Use of ETC-1002 in a previous clinical study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ETC-1002 120 mg/day	ETC-1002	Orally, once daily in morning as capsules
ETC-1002 180 mg/day	ETC-1002	Orally, once daily in morning as capsules
ETC-1002 120 mg/day + ezetimibe 10mg/day	ETC-1002	Orally, once daily in morning
ETC-1002 180 mg/day + ezetimibe 10mg/day	ETC-1002	Orally, once daily in morning
ezetimibe 10mg/day	Ezetimibe	Orally, once daily in morning as capsules
ETC-1002 120 mg/day + ezetimibe 10mg/day	Ezetimibe	Orally, once daily in morning
ETC-1002 180 mg/day + ezetimibe 10mg/day	Ezetimibe	Orally, once daily in morning

Primary Outcome Measures

Name	Time	Method
Percent change in calculated low density lipoprotein-cholesterol (LDL-C)	Baseline and 12 weeks

Secondary Outcome Measures

Name	Time	Method
Percent change in other lipid measures non high density lipoprotein cholesterol (nonHDL-C)	Baseline and 12 weeks
Safety using adverse event reports; vital signs	up to 21 weeks including screening
Percent change in Apolipoprotein B (ApoB)	Baseline and 12 weeks
Percent change in high sensitivity C-reactive protein (hsCRP)	Baseline and 12 weeks
Safety using adverse event reports; clinical laboratory results	up to 21 weeks including screening
Safety using adverse event reports; rates of muscle-related adverse	up to 21 weeks including screening