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

Study acronym: Musashi
StatusRecruiting
PhaseNot specified
Started

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Trial flagged as At Risk
Primary completion moved at least 2 months later Sep 1, 2028 → Nov 22, 2028
Enrollment reduced 17% 2560 → 2120 participants
See other at-risk trials from Daiichi Sankyo

Record History

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  1. Trial sites expanded: 23 → 38 locations
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: details revised at 10 of 10 entries
  2. Enrollment reopenedv4 Show 4 more changesShow less
    • Primary completion pushed from Sep 1, 2028 to Nov 22, 2028
    • Enrollment reduced: 2560 → 2120 participants
    • Trial sites expanded: 1 → 23 locations
    • Study completion moved earlier from Mar 1, 2029 to Dec 31, 2028
  3. Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Jan 30, 2026 to Mar 3, 2026
    v3
  4. Start date: Nov 30, 2025 to Jan 30, 2026v2
  5. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Daiichi Sankyo
70 trials monitored
See 8 trials at risk
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.
Trial Details
NCT Number NCT07206472
Lead Sponsor Daiichi Sankyo
Conditions
(from sponsor)		 Primary Hypercholesterolaemia, Mixed Dyslipidemia
Enrollment 2,120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov