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Cohort 3 for High cholesterol
Phase 1
Waitlist Available
Research Sponsored by Esperion Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 or 28 days
Summary
This Phase 1, double-blind (sponsor open) study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of ETC-1002 given to subjects with mild dyslipidemia.
Eligible Conditions
- High cholesterol
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 14 or 28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 or 28 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Characterization of pharmacokinetic parameters and percent change from baseline in pharmacodynamic endpoints
Trial Design
5Treatment groups
Experimental Treatment
Group I: Cohort 5Experimental Treatment1 Intervention
Free-living subjects (18 active/6 placebo) with mild dyslipidemia
Group II: Cohort 4Experimental Treatment1 Intervention
Subjects (6 active/2 placebo) with mild dyslipidemia in Phase 1 Unit
Group III: Cohort 3Experimental Treatment1 Intervention
Subjects (6 active/2 placebo) with mild dyslipidemia in Phase 1 Unit
Group IV: Cohort 2Experimental Treatment1 Intervention
Subjects (6 active/2 placebo) with mild dyslipidemia in Phase 1 Unit
Group V: Cohort 1Experimental Treatment1 Intervention
Subjects (6 active/2 placebo) with mild dyslipidemia in Phase 1 Unit
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ETC-1002 or placebo
2010
Completed Phase 1
~60
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Esperion Therapeutics, Inc.Lead Sponsor
25 Previous Clinical Trials
21,865 Total Patients Enrolled
Jim C Khalifa, MDStudy DirectorEsperion Therapeutics, Inc.
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