A Study of the Safety, Pharmacokinetic Drug Interaction and Efficacy of ETC-1002 and Atorvastatin in Subjects With Hypercholesterolemia

A Placebo-Controlled, Randomized, Double-Blind, Parallel Group, Drug Interaction Study to Evaluate the Safety, Tolerability and Effect on Atorvastatin Pharmacokinetics of ETC-1002 Added to Atorvastatin 10 mg/Day in Subjects With Hypercholesterolemia

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01779453

Enrollment

Registered

2013-01-30

Start date

2012-12-31

Completion date

2013-08-31

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

Atorvastatin, Drug-drug interaction, Combination therapy

Brief summary

This study will assess the safety, atorvastatin pharmacokinetics, and LDL-C lowering efficacy of ETC-1002 versus placebo in hypercholesterolemic subjects on background therapy of atorvastatin 10 mg.

Interventions

DRUGETC-1002

Week 1-2, 60 mg/day; Week 3-4, 120 mg/day; Week 5-6, 180 mg/day; Week 7-8, 240 mg/day

DRUGPlacebo

Placebo once daily for 8 weeks

DRUGAtorvastatin

Atorvastatin 10mg once daily for 8 weeks

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

* For subjects on current daily statin therapy - LDL-C 100-220 mg/dL and triglycerides \<350 mg/dL (prior to switching to sponsor -provided atorvastatin 10 mg/day and stopping all other lipid-regulating drugs and supplements) at the S1 Visit, * For subjects not on current daily statin therapy - LDL-C ≥ 110 mg/dL and ≤ 220 mg/dL

Exclusion criteria

* Acute significant cardiovascular disease * Uncontrolled hypertension

Design outcomes

Primary

Measure	Time frame
Area under the plasma concentration versus time curve (AUC) of atorvastatin and its active metabolites	4 and 8 weeks
Peak plasma concentration (Cmax) of atorvastatin and its active metabolites	4 and 8 weeks
Number of subjects with adverse events, clinical lab abnormalities and other safety findings	8 weeks

Secondary

Measure	Time frame
Percent change in LDL-C	2, 4, 6 and 8 weeks
Percent change in other lipids and cardio-metabolic risk factors	2, 4, 6 and 8 weeks

Other

Measure	Time frame
Area under the plasma concentration versus time curve (AUC) and peak plasma concentration (Cmax) of ETC-1002 and its active metabolite	4 and 8 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026