Bempedoic Acid Versus Statins in Primary-Prevention Patients With Suboptimal Statin Adherence: Effects on LDL-C Reduction and Tolerability

Sponsor
Sohaib Ashraf
Study ID
NCT07239414
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Cardiovascular

Eligibility Criteria

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

Interventions

Study Details

Bempedoic acid is an oral, non-statin LDL-cholesterol (LDL-C) lowering agent that inhibits ATP citrate lyase (ACL), upstream of HMG-CoA reductase (the enzyme inhibited by statins). MDPI +1 In patients with hypercholesterolemia who are unable to tolerate statins, or have sub-optimal statin adherence/tolerance, bempedoic acid has been shown to reduce LDL-C by \~20-30% (monotherapy) and more when added to other therapies (e.g., ezetimibe) (≈30-40%). PubMed * 2 medicinejournal.in * 2 In the large primary-prevention subgroup of the trial CLEAR Outcomes (statin-intolerant patients without prior cardiovascular event), bempedoic acid (180 mg daily) lowered LDL-C by \~21.3% and hs-CRP by \~21.5%. It also was associated with a significant reduction in major adverse cardiovascular events (MACE): hazard ratio 0.70 (95% CI 0.55-0.89) versus placebo over \~40 months. PubMed +1 Regarding tolerability: muscle-related adverse events appear lower compared to statins (because bempedoic acid is activated only in the liver, not in skeletal muscle) and it appears generally well tolerated, but there are signals of increased uric acid/gout, elevated hepatic enzymes, and creatinine/renal effects. MDPI +1 Comparative cardiovascular benefit (when normalized per unit LDL-C reduction) suggests that bempedoic acid may yield similar relative risk reductions as statins, though absolute LDL-C lowering is less.

Key Dates

Start date
Nov 10, 2025
Status verified
Nov 2025
Primary completion
Nov 10, 2026
Completion
Feb 21, 2027

Study Design

Enrollment
690 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Arm A (Bempedoic acid)
    BA 180 mg once daily + placebo statin.
  • Placebo Comparator: Arm B (Statin)
    Rosuvastatin 5 mg once daily + placebo BA.

Primary Outcome Measure

Percentage change in LDL-C [ Time Frame: 6 months ]

Central Contacts

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