A Multiple Ascending Dose Study of ETC-1002 in Subjects With Mild Dyslipidemia
NCT ID: NCT01105598
Last Updated: 2019-03-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
53 participants
INTERVENTIONAL
2010-04-20
2010-10-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Cohort 1
Subjects (6 active/2 placebo) with mild dyslipidemia in Phase 1 Unit
ETC-1002 or placebo
ETC-1002 (20 mg), daily for 14 days
Cohort 2
Subjects (6 active/2 placebo) with mild dyslipidemia in Phase 1 Unit
ETC-1002 or placebo
ETC-1002 (ascending dose), daily for 14 days
Cohort 3
Subjects (6 active/2 placebo) with mild dyslipidemia in Phase 1 Unit
ETC-1002 or placebo
ETC-1002 (ascending dose), daily for 14 days
Cohort 4
Subjects (6 active/2 placebo) with mild dyslipidemia in Phase 1 Unit
ETC-1002 or placebo
ETC-1002 (ascending dose), daily for 14 days
Cohort 5
Free-living subjects (18 active/6 placebo) with mild dyslipidemia
ETC-1002 or placebo
ETC-1002 (optimized dose), daily for 28 days
Interventions
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ETC-1002 or placebo
ETC-1002 (ascending dose), daily for 14 days
ETC-1002 or placebo
ETC-1002 (optimized dose), daily for 28 days
ETC-1002 or placebo
ETC-1002 (20 mg), daily for 14 days
Eligibility Criteria
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Inclusion Criteria
* Fasting low density lipoprotein-cholesterol (LDL-C) of 100-160 mg/dL
* Fasting triglycerides (TG) of 100-350 mg/dL (Cohort 5 only)
* Body Mass Index (BMI) of 18-32 kg/m2 (Cohort 1 to 4 only) or 18-36 (Cohort 5 only) and body weight \>50 kg
Exclusion Criteria
* Alanine aminotransferase (ALT) or aspartate amino transferase (AST) \>1.2 x ULN; serum creatinine \>ULN; hemoglobin \<12.0 g/dL; other clinical lab tests (with the exception of ALT, AST, serum creatinine and hemoglobin) outside normal or protocol specified limits that are determined by the Investigator to be clinically significant
* Use of tobacco or tobacco products
* Use of any prescription or nonprescription drugs, vitamins, or dietary supplements within 14 days prior to randomization with the exception of lipid regulating drugs or supplements containing niacin \>500 mg/day or fish oil which will not have been used for 3 months prior to randomization
18 Years
55 Years
ALL
Yes
Sponsors
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Esperion Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jim C Khalifa, MD
Role: STUDY_DIRECTOR
Esperion Therapeutics, Inc.
Locations
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Jasper Clinic, Inc.
Kalamazoo, Michigan, United States
Countries
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Other Identifiers
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ETC-1002-002
Identifier Type: -
Identifier Source: org_study_id
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