Lipid-efficacy RCT · N Engl J Med 2025
BROADWAY trial
Safety and Efficacy of Obicetrapib in Patients at High Cardiovascular Risk.
The bottom line
In high-risk patients already on maximum tolerated lipid-lowering therapy, adding obicetrapib 10 mg daily lowered LDL cholesterol by about 30% more than placebo with a similar rate of adverse events.
Primary lipid endpoint metUS status: Investigational
At a glance
- Medicine
- Obicetrapib 10 mg once daily (n=1686)
- Compared with
- Matching placebo (n=844)
- People
- 2,530
- Who took part
- Patients with heterozygous familial hypercholesterolemia or a history of atherosclerotic cardiovascular disease, receiving maximum tolerated doses of lipid-lowering therapy, with LDL cholesterol ≥100 mg/dl or non-HDL ≥130 mg/dl, or LDL 55-100 mg/dl or non-HDL 85-130 mg/dl plus at least one additional cardiovascular risk factor
- Design
- multinational, randomized, placebo-controlled trial, 2:1 randomization
- Follow-up
- 365 days
- Main question
- Percent change in LDL cholesterol level from baseline to day 84
Main result
Least-squares mean percent change from baseline to day 84 in LDL cholesterol: -29.9% (95% CI, -32.1 to -27.8) with obicetrapib vs 2.7% (95% CI, -0.4 to 5.8) with placebo, between-group difference -32.6 percentage points (95% CI, -35.8 to -29.5; P<0.001)
Effect on LDL cholesterol
-29.9% (95% CI, -32.1 to -27.8) vs 2.7% (95% CI, -0.4 to 5.8) with placebo; between-group difference -32.6 percentage points (95% CI, -35.8 to -29.5; P<0.001)
Other results
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Safety
The incidence of adverse events appeared to be similar in the two groups.
In the trial's own words
“The least-squares mean percent change from baseline to day 84 in the LDL cholesterol level was -29.9% (95% confidence interval [CI], -32.1 to -27.8) in the obicetrapib group, as compared with 2.7% (95% CI, -0.4 to 5.8) in the placebo group, for a between-group difference of -32.6 percentage points (95% CI, -35.8 to -29.5; P<0.001).”
Quoted from the abstract of N Engl J Med 2025, checked word for word against PubMed. PubMed 40337982 · Full paper (DOI)
How this medicine works, where it stands and what it costs: Obicetrapib
Common questions
What did the BROADWAY trial find?
In high-risk patients already on maximum tolerated lipid-lowering therapy, adding obicetrapib 10 mg daily lowered LDL cholesterol by about 30% more than placebo with a similar rate of adverse events.
Who was in BROADWAY?
2,530 people. Patients with heterozygous familial hypercholesterolemia or a history of atherosclerotic cardiovascular disease, receiving maximum tolerated doses of lipid-lowering therapy, with LDL cholesterol ≥100 mg/dl or non-HDL ≥130 mg/dl, or LDL 55-100 mg/dl or non-HDL 85-130 mg/dl plus at least one additional cardiovascular risk factor.
What was BROADWAY's main result?
Least-squares mean percent change from baseline to day 84 in LDL cholesterol: -29.9% (95% CI, -32.1 to -27.8) with obicetrapib vs 2.7% (95% CI, -0.4 to 5.8) with placebo, between-group difference -32.6 percentage points (95% CI, -35.8 to -29.5; P<0.001)
How much did LDL cholesterol change in BROADWAY?
-29.9% (95% CI, -32.1 to -27.8) vs 2.7% (95% CI, -0.4 to 5.8) with placebo; between-group difference -32.6 percentage points (95% CI, -35.8 to -29.5; P<0.001)
Related trials
- BROOKLYN (2026)In patients with heterozygous familial hypercholesterolemia already on maximally tolerated lipid-lowering therapy, adding obicetrapib substantially lowered LDL cholesterol (and improved other lipid parameters) compared with placebo and was well tolerated.
- ACCELERATE (2017)Despite markedly improving LDL and HDL cholesterol levels, evacetrapib did not reduce cardiovascular events compared with placebo in high-risk vascular disease patients, and the trial was stopped early for futility.
- REVEAL (2017)Adding the CETP inhibitor anacetrapib to intensive statin therapy modestly reduced major coronary events in patients with atherosclerotic vascular disease, without significant safety concerns.
- dal-OUTCOMES (2012)In patients with a recent acute coronary syndrome, dalcetrapib raised HDL cholesterol but did not reduce cardiovascular events or mortality compared with placebo.
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