NCT01262638

Brief Summary

This Phase 2 proof-of-concept study will assess the lipid regulating efficacy and safety of ETC-1002 in subjects with hypercholesterolemia and either normal or elevated triglycerides.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
177

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

11 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

December 1, 2010

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

December 16, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 17, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 23, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 23, 2011

Completed
9.6 years until next milestone

Results Posted

Study results publicly available

March 16, 2021

Completed
Last Updated

March 17, 2021

Status Verified

March 1, 2021

Enrollment Period

9 months

First QC Date

December 16, 2010

Results QC Date

February 22, 2021

Last Update Submit

March 15, 2021

Conditions

Dyslipidemia

Outcome Measures

Primary Outcomes (2)

  • Percent Change From Baseline to Week 12 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 mean of the values from Weeks -1 and 0. Least square (LS) mean percent change from Baseline to Week 12 was based on an analysis of covariance (ANCOVA) model with effects of treatment and triglyceride (TG) stratum and Baseline value as a covariate. Missing LDL-C values at Week 12 were imputed using the last observation carried forward (LOCF) procedure (only post-Baseline values were carried forward).

    Baseline; 12 weeks

  • Percent Change From Baseline to Week 12 in LDL-C by Triglyceride (TG) Stratum

    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 mean of the values from Weeks -1 and 0. LS mean percent change from Baseline to Week 12 was based on an ANCOVA model with effects of treatment and center and Baseline value as a covariate. Missing LDL-C values at Week 12 were imputed using the LOCF procedure (only post-Baseline values were carried forward).

    Baseline; 12 weeks

Secondary Outcomes (16)

  • Percent Change From Baseline to Week 12 in TG

    Baseline; 12 weeks

  • Percent Change From Baseline to Week 12 in High-Density Lipoprotein-Cholesterol (HDL-C)

    Baseline; 12 weeks

  • Percent Change From Baseline to Week 12 in Non-HDL-C

    Baseline; 12 weeks

  • Percent Change From Baseline to Week 12 in Total Cholesterol (TC)

    Baseline; 12 weeks

  • Percent Change From Baseline to Week 12 in Apolipoprotein B (ApoB)

    Baseline; 12 weeks

  • +11 more secondary outcomes

Study Arms (8)

ETC-1002 120 mg (Group 1)

EXPERIMENTAL

Subjects with hypercholesterolemia and normal triglycerides

Drug: ETC-1002

ETC-1002 80 mg (Group 2)

EXPERIMENTAL

Subjects with hypercholesterolemia and normal triglycerides

Drug: ETC-1002

ETC-1002 40 mg (Group 3)

EXPERIMENTAL

Subjects with hypercholesterolemia and normal triglycerides

Drug: ETC-1002

Placebo (Group 4)

EXPERIMENTAL

Subjects with hypercholesterolemia and normal triglycerides

Drug: Placebo

ETC-1002 120 mg (Group 5)

EXPERIMENTAL

Subjects with hypercholesterolemia and elevated triglycerides

Drug: ETC-1002

ETC-1002 80 mg (Group 6)

EXPERIMENTAL

Subjects with hypercholesterolemia and elevated triglycerides

Drug: ETC-1002

ETC-1002 40 mg (Group 7)

EXPERIMENTAL

Subjects with hypercholesterolemia and elevated triglycerides

Drug: ETC-1002

Placebo (Group 8)

EXPERIMENTAL

Subjects with hypercholesterolemia and elevated triglycerides

Drug: Placebo

Interventions

ETC-1002DRUG

ETC-1002 daily for 12 weeks

ETC-1002 120 mg (Group 1)ETC-1002 120 mg (Group 5)ETC-1002 40 mg (Group 3)ETC-1002 40 mg (Group 7)ETC-1002 80 mg (Group 2)ETC-1002 80 mg (Group 6)
PlaceboDRUG

Placebo daily for 12 weeks

Placebo (Group 4)Placebo (Group 8)

Eligibility Criteria

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

You may qualify if:

  • Provision of written informed consent prior to any study-specific procedure
  • Fasting LDL-C between 130 and 220 mg/dL following wash-out of all lipid regulating medications and supplements
  • Fasting triglyceride \<400 mg/dL following wash-out of all lipid regulating medications and supplements
  • BMI between 18 and 35 mg/kg2

You may not qualify if:

  • Clinically significant cardiovascular disease, diabetes or uncontrolled hypertension
  • Females of child bearing potential (i.e., females who are not surgically sterile or post-menopausal)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Unknown Facility

Chandler, Arizona, 85225, United States

Location

Unknown Facility

Greenbrae, California, 94904, United States

Location

Unknown Facility

Santa Rosa, California, 95405, United States

Location

Unknown Facility

Jacksonville, Florida, 32216, United States

Location

Unknown Facility

Chicago, Illinois, 60654, United States

Location

Unknown Facility

Iowa City, Iowa, 52242, United States

Location

Unknown Facility

Louisville, Kentucky, 40213, United States

Location

Unknown Facility

Kalamazoo, Michigan, 49007, United States

Location

Unknown Facility

Raleigh, North Carolina, 27609, United States

Location

Unknown Facility

Houston, Texas, 77030, United States

Location

Unknown Facility

Richmond, Virginia, 23294, United States

Location

Related Publications (1)

  • Ballantyne CM, Davidson MH, Macdougall DE, Bays HE, Dicarlo LA, Rosenberg NL, Margulies J, Newton RS. Efficacy and safety of a novel dual modulator of adenosine triphosphate-citrate lyase and adenosine monophosphate-activated protein kinase in patients with hypercholesterolemia: results of a multicenter, randomized, double-blind, placebo-controlled, parallel-group trial. J Am Coll Cardiol. 2013 Sep 24;62(13):1154-62. doi: 10.1016/j.jacc.2013.05.050. Epub 2013 Jun 13.

    PMID: 23770179RESULT

MeSH Terms

Conditions

Dyslipidemias

Interventions

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

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Results Point of Contact

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

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 16, 2010

First Posted

December 17, 2010

Study Start

December 1, 2010

Primary Completion

August 23, 2011

Study Completion

August 23, 2011

Last Updated

March 17, 2021

Results First Posted

March 16, 2021

Record last verified: 2021-03

Locations

US(11)