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Completed

NCT Number: NCT01941836

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

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.

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Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ETC-1002

Drug

Patients receive ETC-1002

ezetimibe

Drug

Patients receive ezetimibe

Other names: Zetia

Primary outcomes

  1. Percent change in calculated low density lipoprotein-cholesterol (LDL-C)

    Time frame: Baseline and 12 weeks

Secondary outcomes

  1. Percent change in other lipid measures non high density lipoprotein cholesterol (nonHDL-C)

    Time frame: Baseline and 12 weeks

  2. Safety using adverse event reports; vital signs

    Time frame: up to 21 weeks including screening

  3. Percent change in Apolipoprotein B (ApoB)

    Time frame: Baseline and 12 weeks

  4. Percent change in high sensitivity C-reactive protein (hsCRP)

    Time frame: Baseline and 12 weeks

  5. Safety using adverse event reports; clinical laboratory results

    Time frame: up to 21 weeks including screening

  6. Safety using adverse event reports; rates of muscle-related adverse

    Time frame: up to 21 weeks including screening

Other outcomes

  1. Pharmacokinetic plasma trough concentrations of ETC-1002 and its metabolite ESP15228

    Time frame: Week 2, Week 4, Week 8 and Week 12

Sponsors and collaborators

Lead sponsor

Esperion Therapeutics, Inc.

Industry

Collaborators

  • Medpace, Inc.

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Sep 13, 2013
Registry last updated
Mar 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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