A Study of Bempedoic Acid/Ezetimibe/High-intensity Statin in Patients Without Cardiovascular Events

Sponsor
Daiichi Sankyo
Study ID
NCT07474649
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bempedoic acid — DRUG
    FDC: 180 mg
  • Ezetimibe — DRUG
    FDC: 10 mg
  • Rosuvastatin — DRUG
    20 mg dose
  • Atorvastatin — DRUG
    40 mg dose

Study Details

The overall objective of the trial is to evaluate the effect of the triple therapy consisting of bempedoic acid (BA), ezetimibe (EZE), and high-intensity atorvastatin or rosuvastatin on changes in coronary plaque burden and plaque morphology in patients with coronary atherosclerosis without significant obstructive coronary artery disease and without prior history of an ischemic vascular event.

Key Dates

Start date
Jun 1, 2026
Status verified
Mar 2026
Primary completion
Jun 1, 2028
Completion
Oct 2, 2028

Study Design

Enrollment
103 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Bempedoic acid (BA)/ezetimibe (EZE) fixed dose combination (FDC) with rosuvastatin or atorvastatin
    Treatment-naïve participants with coronary atherosclerosis and primary non-familial hypercholesterolaemia or mixed dyslipidaemia who will receive daily treatment with BA/EZE FDC, together with either 20 mg rosuvastatin or 40 mg atorvastatin.

Primary Outcome Measure

Annualised change in percentage plaque burden (Δ%PB) [ Time Frame: Baseline up to 12 months ]

Central Contacts

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