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

Sponsor
Daiichi Sankyo
Study ID
NCT07206472
Status
Recruiting
Apply to this trial

Conditions

  • Mixed Dyslipidemia
  • Primary Hypercholesterolaemia

Eligibility Criteria

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

Interventions

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

First listed
Oct 3, 2025
Start date
Mar 3, 2026
Status verified
Jul 2026
Primary completion
Nov 22, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
2,120 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 ]

Central Contacts