Clinical trial NCT01751984: A Study of the Efficacy and Safety of ETC-1002 in Participants With Statin Intolerance
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 a History of Statin Intolerance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypercholesterolemia
Keywords: lipid-lowering drugs
statin intolerance
Lead sponsor: Esperion Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2012-12-18
Enrollment: 56
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 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.


Eligibility criteria: Key Inclusion Criteria:

* 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

Key Exclusion Criteria:

* Acute significant cardiovascular disease
* Poorly controlled hypertension

Primary outcomes:
measure: Percent Change From Baseline to Week 8 in Calculated Low-Density Lipoprotein-Cholesterol (LDL-C)
timeFrame: Baseline; 8 weeks
Secondary outcomes:
measure: Percent Change From Baseline to Weeks 2, 4, 6, and 8 in Calculated LDL-C
timeFrame: Baseline; Weeks 2, 4, 6, and 8
measure: Percent Change From Baseline to Week 8 in High-Density Lipoprotein-Cholesterol (HDL-C)
timeFrame: Baseline; 8 weeks
measure: Percent Change From Baseline to Week 8 in Non-HDL-C
timeFrame: Baseline; 8 weeks
measure: Percent Change From Baseline to Week 8 in Total Cholesterol
timeFrame: Baseline; 8 weeks
measure: Percent Change From Baseline to Week 8 in Triglycerides
timeFrame: Baseline; 8 weeks
measure: Percent Change From Baseline to Week 8 in Apolipoprotein B
timeFrame: Baseline; 8 weeks
measure: Percent Change From Baseline to Week 8 in Apolipoprotein AI
timeFrame: Baseline; 8 weeks
measure: Percent Change From Baseline to Week 8 in Lipoprotein (a)
timeFrame: Baseline; 8 weeks
measure: Percent Change From Baseline to Week 8 in High-Sensitivity C-Reactive Protein (hsCRP)
timeFrame: Baseline; 8 weeks
measure: Percent Change From Baseline to Week 8 in Free Fatty Acids (FFA)
timeFrame: Baseline; 8 weeks
measure: Number of Participants Achieving Their National Cholesterol Education Program Adult Treatment Panel III (NCEP ATPIII) LDL-C Goal (<100 Milligrams Per Deciliter [mg/dL]) After 8 Weeks of Treatment
timeFrame: Baseline; up to 8 weeks
measure: Number or Participants With Treatment-emergent Adverse Events (TEAEs)
timeFrame: up to 8 weeks
measure: Number of Participants With Muscle-Related TEAEs
timeFrame: up to 8 weeks
Other outcomes:
Locations:
city: Hartford
country: United States
state: Connecticut
city: Indianapolis
country: United States
state: Indiana
city: Raleigh
country: United States
state: North Carolina
city: Wilmington
country: United States
state: North Carolina
city: Knoxville
country: United States
state: Tennessee
Study officials:
affiliation: Esperion Therapeutics, Inc.
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.