Clinical trial NCT01262638: A Study to Assess the Efficacy and Safety of ETC-1002 in Subjects With Elevated Blood Cholesterol and Either Normal or Elevated Triglycerides
Official title: A Placebo-Controlled, Randomized, Double-Blind, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of ETC-1002 in Subjects With Hypercholesterolemia and Either Normal or Elevated Triglycerides.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dyslipidemia
Lead sponsor: Esperion Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2010-12-17
Enrollment: 177
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Major Inclusion Criteria:

* 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

Major Exclusion Criteria:

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

Primary outcomes:
measure: Percent Change From Baseline to Week 12 in Calculated Low-Density Lipoprotein-Cholesterol (LDL-C)
timeFrame: Baseline; 12 weeks
measure: Percent Change From Baseline to Week 12 in LDL-C by Triglyceride (TG) Stratum
timeFrame: Baseline; 12 weeks
Secondary outcomes:
measure: Percent Change From Baseline to Week 12 in TG
timeFrame: Baseline; 12 weeks
measure: Percent Change From Baseline to Week 12 in High-Density Lipoprotein-Cholesterol (HDL-C)
timeFrame: Baseline; 12 weeks
measure: Percent Change From Baseline to Week 12 in Non-HDL-C
timeFrame: Baseline; 12 weeks
measure: Percent Change From Baseline to Week 12 in Total Cholesterol (TC)
timeFrame: Baseline; 12 weeks
measure: Percent Change From Baseline to Week 12 in Apolipoprotein B (ApoB)
timeFrame: Baseline; 12 weeks
measure: Percent Change From Baseline to Week 12 in Apolipoprotein AI (ApoAI)
timeFrame: Baseline; 12 weeks
measure: Percent Change From Baseline to Week 12 in Lipoprotein (a)
timeFrame: Baseline; 12 weeks
measure: Percent Change From Baseline to Week 12 in Free Fatty Acids (FFA)
timeFrame: Baseline; 12 weeks
measure: Percent Change From Baseline to Week 12 in High-Sensitivity C-Reactive Protein (hsCRP)
timeFrame: Baseline; 12 weeks
measure: Percent Change From Baseline to Week 12 in Total LDL Particles
timeFrame: Baseline; 12 weeks
measure: Percent Change From Baseline to Week 12 in Total HDL Particles
timeFrame: Baseline; 12 weeks
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
timeFrame: up to 12 weeks
measure: Number of Participants With Clinically Significant Physical Examination Findings
timeFrame: up to 12 weeks
measure: Number of Participants With Clinically Important Changes From Baseline in Vital Sign Values
timeFrame: Baseline; up to 12 weeks
measure: Number of Participants With Clinically Important Changes From Baseline in Electrocardiogram Values
timeFrame: Baseline; up to 12 weeks
measure: Number of Participants With the Indicated Abnormal Laboratory Parameter Values at Week 12
timeFrame: Week 12
Other outcomes:
Locations:
city: Chandler
country: United States
state: Arizona
city: Greenbrae
country: United States
state: California
city: Santa Rosa
country: United States
state: California
city: Jacksonville
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Iowa City
country: United States
state: Iowa
city: Louisville
country: United States
state: Kentucky
city: Kalamazoo
country: United States
state: Michigan
city: Raleigh
country: United States
state: North Carolina
city: Houston
country: United States
state: Texas
city: Richmond
country: United States
state: Virginia
Study officials:
References:
citation: 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.