Oral PCSK9 Inhibitor Enlicitide Versus Oral Nonstatin Therapies: A Phase 3 Randomized Clinical Trial
Authors' conclusion
In statin-treated adults with a history of a major ASCVD event or at increased risk for a first event, enlicitide achieved greater reductions in LDL-C, ApoB, and nonHDL-C than other oral nonstatin therapies
Study context
- Population
- Statin-treated adults ≥18 y with low-density lipoprotein cholesterol (LDL-C) ≥55 mg/dL and prior major atherosclerotic cardiovascular disease (ASCVD) event, or LDL-C ≥70 mg/dL at intermediate to high risk for a first event298 (99.0%) completed
- Participants
- 301 adults
- Comparison
- Oral PCSK9 inhibitor enlicitide vs other oral nonstatin therapies
- Enlicitiden = 101
- Bempedoic acidn = 50reference
- Ezetimiben = 50reference
- Bempedoic acid plus ezetimiben = 100reference
- Primary endpoint
- Mean percentage change in LDL-C from baseline
- Follow-up
- Day 56
Methodological detailsphase 3, double-blind, active-comparator
- Phase 3
- Double-blind
- Active-comparator
Primary result
As reported in the abstract
Mean % change in LDL-C
Enlicitide
−64.6%
mean percentage change · 95% CI −68.3%–-60.9%
Bempedoic acid
−6.3%
mean percentage change · 95% CI −13.5%–0.8%
Ezetimibe
−27.8%
mean percentage change · 95% CI −32.3%–-23.4%
Bempedoic acid plus ezetimibe
−36.5%
mean percentage change · 95% CI −40.8%–-32.2%
- Enlicitide superior to each comparator
- all P < 0.001
Secondary outcomes
Mean % change in apolipoprotein B (ApoB) and nonHDL-C
- Reductions greater with enlicitide
- all P < 0.001
Safety
Adverse events (AEs) and discontinuations due to AEs
- Proportions similar across treatment arms
Original publication
Oral PCSK9 Inhibitor Enlicitide Versus Oral Nonstatin Therapies: A Phase 3 Randomized Clinical Trial. J Am Coll Cardiol. Published 30 March 2026. doi:10.
Summarised from the published abstract; every number is checked against it