Overview

This trial has been completed.

Condition hyperlipidemia
Treatments etc-1002, atorvastatin, placebo
Phase phase 2
Sponsor Esperion Therapeutics
Start date December 2015
End date July 2016
Trial size 68 participants
Trial identifier NCT02659397, 1002-035

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification pharmacokinetics/dynamics study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
ETC-1002 180 mg treatment, oral once daily added-on to Atorvastatin 80 mg once daily
etc-1002 bempedoic acid
Blinded ETC-1002 180 mg tablet once daily for 4 weeks (Weeks 1 to 4)
atorvastatin
Atorvastatin 80 mg tablet once daily for 8 weeks (Weeks -4 to 4)
(Placebo Comparator)
Placebo treatment, oral once daily added-on to Atorvastatin 80 mg once daily
atorvastatin
Atorvastatin 80 mg tablet once daily for 8 weeks (Weeks -4 to 4)
placebo
Blinded ETC-1002-matched placebo tablet once daily for 4 weeks (Weeks 1 to 4)

Primary Outcomes

Measure
Peak plasma concentration (Cmax) pharmacokinetics of atorvastatin and its active metabolites
time frame: 2 weeks
24-hour area under the curve (AUC) pharmacokinetics of atorvastatin and its active metabolites
time frame: 2 weeks
Percent change in LDL-cholesterol
time frame: 4 weeks

Secondary Outcomes

Measure
Percent change in hsCRP
time frame: 4 weeks
Percent change in total cholesterol
time frame: 4 weeks
Percent change in non-HDL-cholesterol
time frame: 4 weeks
Percent change in apolipoprotein B
time frame: 4 weeks
24-hour post dose plasma concentration pharmacokinetics of ETC-1002 and its active metabolite
time frame: 2 weeks

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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.

Additional Information

Official title A Study to Assess the Pharmacokinetics, Pharmacodynamics and Safety of Adding ETC-1002 180 mg to Atorvastatin 80 mg Background Therapy in Statin-Treated Patients
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Esperion Therapeutics.