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Evaluation of Major Cardiovascular Events in Participants With, or at High Risk for, Cardiovascular Disease Who Are Statin Intolerant Treated With Bempedoic Acid (ETC-1002) or Placebo (CLEAR Outcomes Trial)

Phase 3
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 older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 68 months
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
Pivotal Trial

Summary

This trial is testing whether bempedoic acid can lower the risk of heart problems in people who have or are at high risk for heart disease and cannot take statins. Bempedoic acid helps by reducing cholesterol levels in the blood.

Eligible Conditions
  • Cardiovascular Disease
  • Statin Adverse Reaction Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 68 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 68 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants With First Occurrence of Four Component Major Adverse Cardiovascular Events (MACE)
Secondary study objectives
Number of Participants With First Occurrence of Myocardial Infarction
Number of Participants With First Occurrence of Three Component MACE
Number of Participants With Time to All-cause Mortality
+3 more

Side effects data

From 2022 Phase 3 trial • 13970 Patients • NCT02993406
11%
Hyperuricaemia
11%
Hypertension
10%
COVID-19
8%
Arthralgia
8%
Urinary tract infection
7%
Diabetes mellitus
7%
Headache
6%
Back pain
6%
Myalgia
6%
Blood uric acid increased
5%
Nasopharyngitis
1%
Pneumonia
1%
Angina pectoris
1%
Osteoarthritis
1%
COVID-19 pneumonia
1%
Transient ischaemic attack
1%
Non-cardiac chest pain
1%
Cholelithiasis
1%
Cardiac failure congestive
1%
Angina unstable
1%
Atrial fibrillation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bempedoic Acid 180 mg
Placebo Comparator

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Bempedoic Acid 180 mgExperimental Treatment1 Intervention
Bempedoic acid 180 mg tablet taken orally, once daily.
Group II: Placebo ComparatorPlacebo Group1 Intervention
Matching placebo tablet taken orally, once daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bempedoic acid
FDA approved

Find a Location

Who is running the clinical trial?

Esperion Therapeutics, Inc.Lead Sponsor
25 Previous Clinical Trials
7,948 Total Patients Enrolled
The Cleveland ClinicOTHER
1,056 Previous Clinical Trials
1,357,647 Total Patients Enrolled
Michael Louie, MDStudy DirectorEsperion Therapeutics, Inc.
2 Previous Clinical Trials
74 Total Patients Enrolled
~1567 spots leftby Dec 2025
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