Prevention & lipidsRandomised controlled trial
A Placebo-Controlled Trial of the Oral PCSK9 Inhibitor Enlicitide
- Randomised controlled trial
- multinational
- double-blind
- placebo-controlled
Authors' conclusion
Among participants who had a history of or were at risk for a first atherosclerotic cardiovascular disease event, treatment with the oral PCSK9 inhibitor enlicitide resulted in significantly lower LDL cholesterol levels than placebo at 24 weeks.
Study context
- Population
- Adults with prior major atherosclerotic CVD event and LDL-C ≥55 mg/dL, or at risk for a first event with LDL-C ≥70 mg/dLITT population
- Participants
- 2,909 adults
- Comparison
- Oral PCSK9 inhibitor enlicitide 20 mg daily vs placebo
- Enlicitiden = 1,935
- Placebon = 969reference
- Primary endpoint
- Mean percent change in LDL-C from baseline
- Follow-up
- Week 24
Primary result
Mean percent change in LDL-C
Adjusted between-group difference
−55.8 percentage points
95% CI −60.9 to −50.7
P < 0.001
By group
Enlicitide
−57.1
mean percent change · 95% CI −61.8–-52.5 · %
Placebo
3.0
mean percent change · 95% CI 0.9–5.1 · %
As reported in the abstract
Secondary outcomes
LDL-C at week 52; non-HDL cholesterol, apolipoprotein B and lipoprotein(a) at week 24 (key secondary)
- Significantly greater reductions with enlicitide than placebo
- P < 0.001
Safety
Adverse events
- Incidence did not appear to differ between the groups
Original publication
Summarised from the published abstract; every number is checked against it