NCT01751984

Brief Summary

This study will assess the Low-Density Lipoprotein-Cholesterol (LDL-C) lowering efficacy and safety of ETC-1002 versus placebo in participants with hypercholesterolemia and a history of statin intolerance.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 4, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 14, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 18, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
8.9 years until next milestone

Results Posted

Study results publicly available

April 4, 2022

Completed
Last Updated

April 4, 2022

Status Verified

March 1, 2022

Enrollment Period

7 months

First QC Date

December 14, 2012

Results QC Date

February 10, 2022

Last Update Submit

March 10, 2022

Conditions

Hypercholesterolemia

Keywords

lipid-lowering drugsstatin intolerance

Outcome Measures

Primary Outcomes (1)

  • Percent Change From Baseline to Week 8 in Calculated Low-Density Lipoprotein-Cholesterol (LDL-C)

    Percent change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] divided by the Baseline value) x 100. Baseline was defined as the value from Week 0. Least square (LS) mean percent change from Baseline to Week 8 was based on an analysis of covariance (ANCOVA) model with effects of treatment and Baseline value as a covariate. Missing LDL-C values at Week 8 were imputed using the last observation carried forward (LOCF) procedure (only post-Baseline values were carried forward). A negative percent change from Baseline reflects clinical improvement.

    Baseline; 8 weeks

Secondary Outcomes (13)

  • Percent Change From Baseline to Weeks 2, 4, 6, and 8 in Calculated LDL-C

    Baseline; Weeks 2, 4, 6, and 8

  • Percent Change From Baseline to Week 8 in High-Density Lipoprotein-Cholesterol (HDL-C)

    Baseline; 8 weeks

  • Percent Change From Baseline to Week 8 in Non-HDL-C

    Baseline; 8 weeks

  • Percent Change From Baseline to Week 8 in Total Cholesterol

    Baseline; 8 weeks

  • Percent Change From Baseline to Week 8 in Triglycerides

    Baseline; 8 weeks

  • +8 more secondary outcomes

Study Arms (2)

ETC-1002

EXPERIMENTAL

ETC-1002 treatment, once daily oral

Drug: ETC-1002

Placebo

PLACEBO COMPARATOR

Placebo treatment, once daily oral

Drug: Placebo

Interventions

ETC-1002DRUG

Weeks 1-2, 60 milligrams per day (mg/day); Weeks 3-4, 120 mg/day; Weeks 5-6, 180 mg/day; Weeks 7-8, 240 mg/day

ETC-1002
PlaceboDRUG

Placebo once daily for 8 weeks

Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A history of statin intolerance that began during statin treatment and resolved within 4 weeks of stopping the statin treatment
  • For participants on current lipid-regulating drugs - LDL-C 100-220 milligrams per deciliter (mg/dL) and triglycerides \<350 mg/dL (prior to wash-out of all lipid-regulating drugs and supplements)
  • For participants not on current lipid-regulating drugs - LDL-C 115-270 mg/dL and fasting TG \<400 mg/dL

You may not qualify if:

  • Acute significant cardiovascular disease
  • Poorly controlled hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Unknown Facility

Hartford, Connecticut, 06102, United States

Location

Unknown Facility

Indianapolis, Indiana, 46260, United States

Location

Unknown Facility

Raleigh, North Carolina, 27609, United States

Location

Unknown Facility

Wilmington, North Carolina, 28401, United States

Location

Unknown Facility

Knoxville, Tennessee, 37912, United States

Location

Related Publications (1)

  • Thompson PD, Rubino J, Janik MJ, MacDougall DE, McBride SJ, Margulies JR, Newton RS. Use of ETC-1002 to treat hypercholesterolemia in patients with statin intolerance. J Clin Lipidol. 2015 May-Jun;9(3):295-304. doi: 10.1016/j.jacl.2015.03.003. Epub 2015 Mar 19.

    PMID: 26073387RESULT

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Results Point of Contact

Title
Medical Director
Organization
Esperion Therapeutics, Inc.
medinfo@esperion.com
1-833-377-7633

Study Officials

  • Medical Director

    Esperion Therapeutics, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2012

First Posted

December 18, 2012

Study Start

October 4, 2012

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

April 4, 2022

Results First Posted

April 4, 2022

Record last verified: 2022-03

Locations

US(5)