A Study of Bempedoic Acid in Combination With Ezetimibe and Either Rosuvastatin or Atorvastatin in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia

Sponsor
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company
Study ID
NCT06686615
Status
Recruiting
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Conditions

  • Mixed Dyslipidemia
  • Primary Hypercholesterolemiia

Eligibility Criteria

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

Interventions

  • Bempedoic acid — DRUG
    No drug was administered in this observational study.
  • Ezetimibe — DRUG
    No drug was administered in this observational study.
  • Rosuvastatin — DRUG
    No drug was administered in this observational study.
  • Atorvastatin — DRUG
    No drug was administered in this observational study.

Study Details

Data on the real-world use and effectiveness and safety of bempedoic acid combined with both a statin and ezetimibe in clinical practice is limited. There is an increased focus on using combination therapy to lower LDL-C.

Key Dates

Start date
Feb 12, 2025
Status verified
Jun 2026
Primary completion
Jul 31, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
2,000 participants (estimated)

Arms

  • Arm: Triple therapy
    Adult patients who have been diagnosed with primary hypercholesterolaemia (heterozygous familial and nonfamilial) or mixed dyslipidaemia treated with bempedoic acid in combination with ezetimibe and either rosuvastatin or atorvastatin (ie, triple therapy) and will be followed for up to 1 year after initiation of triple therapy. A direct comparison between rosuvastatin and atorvastatin is not planned, only an assessment of triple therapy on LDL-C change in patients with primary hypercholesterolaemia.

Primary Outcome Measure

Relative LDL-C change between untreated and 8 week after triple therapy start [ Time Frame: Baseline to 8 weeks after initiation of triple therapy ]

Central Contacts