Prevention & lipidsRandomised controlled trial
Safety and Efficacy of Obicetrapib in Patients at High Cardiovascular Risk
- Randomised controlled trial
- multinational
- placebo-controlled
- 2:1 randomisation
Authors' conclusion
Among patients with atherosclerotic cardiovascular disease or heterozygous familial hypercholesterolemia who were receiving maximum tolerated doses of lipid-lowering therapy and were at high risk for cardiovascular events, obicetrapib reduced LDL cholesterol levels by 29.9%.
Study context
- Population
- Patients with heterozygous familial hypercholesterolemia or atherosclerotic CVD on maximum tolerated lipid-lowering therapy, at high CV risk
- Participants
- 2,530 patients
- Comparison
- Obicetrapib vs placebo
- Obicetrapibn = 1,686
- Placebon = 844reference
- Primary endpoint
- Percent change in LDL-C from baseline
- Follow-up
- Day 84
Primary result
LDL-C percent change from baseline
Between-group difference
−32.6 percentage points
95% CI −35.8 to −29.5
P < 0.001
By group
Obicetrapib
−29.9
least-squares mean percent change · 95% CI −32.1–-27.8 · %
Placebo
2.7
least-squares mean percent change · 95% CI −0.4–5.8 · %
Obicetrapib vs Placebo
between-group difference −32.6 percentage points (95% CI −35.8 to −29.5); P < 0.001
As reported in the abstract
Safety
Adverse events
- Incidence of adverse events appeared similar in the two groups
Original publication
Safety and Efficacy of Obicetrapib in Patients at High Cardiovascular Risk. N Engl J Med. Published 7 May 2025. doi:10.1056/nejmoa2415820
Summarised from the published abstract; every number is checked against it