Randomised controlled trial
Phase 2b Randomized Trial of the Oral PCSK9 Inhibitor MK-0616
- Randomised controlled trial
- Phase 2b
- double-blind
- placebo-controlled
- multicentre
Authors' conclusion
MK-0616 demonstrated statistically significant and robust, dose-dependent placebo-adjusted reductions in LDL-C at Week 8 of up to 60.9% from baseline and was well tolerated during 8 weeks of treatment and an additional 8 weeks of follow-up.
Study context
- Population
- Adults with hypercholesterolemia and a wide range of atherosclerotic CVD risk380 treated
- Participants
- 381 adults
- Comparison
- MK-0616 vs placebo
- Primary endpoint
- % change from baseline in low-density lipoprotein cholesterol (LDL-C); proportion with AEs and discontinuations due to AEs
- Follow-up
- Week 8
Primary result
As reported in the abstract
LS mean % change in LDL-C from baseline, placebo-adjusted
- 6 mg
- difference −41.2 %; P < 0.001
- 12 mg
- difference −55.7 %; P < 0.001
- 18 mg
- difference −59.1 %; P < 0.001
- 30 mg
- difference −60.9 %; P < 0.001
Safety
| Outcome | Values |
|---|---|
| AEs · 8 weeks treatment + 8 weeks follow-up · similar proportion vs placebo | Placebo 44.0% |
- Adverse events (AEs) — AEs in MK-0616 arms
- 39.5% to 43.4%
Discontinuations due to AEs
- 2 or fewer participants in any treatment group
Original publication
Phase 2b Randomized Trial of the Oral PCSK9 Inhibitor MK-0616. J Am Coll Cardiol. Published 6 March 2023. doi:10.1016/j.jacc.2023.02.018
Summarised from the published abstract; every number is checked against it