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

A Randomized, Double-Blind, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of ETC-1002, Ezetimibe, and the Combination in Hypercholesterolemic Patients With or Without Statin Intolerance

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01941836

Enrollment

349

Registered

2013-09-13

Start date

2013-09-30

Completion date

2014-11-30

Last updated

2019-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolemia

Keywords

Statin intolerant, Statin tolerant, LDL, Cholesterol

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.

Interventions

DRUGETC-1002

Patients receive ETC-1002

DRUGEzetimibe

Patients receive ezetimibe

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

Key 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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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
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 other lipid measures non high density lipoprotein cholesterol (nonHDL-C)	Baseline and 12 weeks

Other

Measure	Time frame
Pharmacokinetic plasma trough concentrations of ETC-1002 and its metabolite ESP15228	Week 2, Week 4, Week 8 and Week 12

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026