A Study of Bempedoic Acid or Its Single-pill Combination Therapy With Ezetimibe in Patients With Primary Hypercholesterolaemia or Mixed Dyslipidaemia

Conditions

• Mixed Dyslipidemia
• Primary Hypercholesterolaemia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Combination of bempedoic acid and ezetimibe — DRUG
  No drug was administered in this observational study.

Study Details

There is limited efficacy and safety data of bempedoic acid or its fixed dose combination (FDC) with ezetimibe in Asian and Latin American patients. This non-interventional study (NIS) will be conducted to characterize the risks and benefits of bempedoic acid or FDC with ezetimibe in a real-world clinical setting in adult patients with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia.

Key Dates

Start date

Mar 3, 2026

Status verified

Mar 2026

Primary completion

Sep 1, 2028

Completion

Mar 1, 2029

Study Design

Enrollment

2,560 participants (estimated)

Arms

• Arm: Bempedoic acid/FDC with ezetimibe
  Adult participants who were diagnosed with primary hypercholesterolemia (heterozygous familial and nonfamilial) or mixed dyslipidemia and treated with bempedoic acid/fixed dose combination (FDC) with ezetimibe in a regular clinical care setting.

Primary Outcome Measure

Incidence of adverse events [ Time Frame: From pre-bempedoic acid/pre-FDC initiation to 1 year after initiation of therapy ]