Prevention & lipids

Olezarsen in patients with hypertriglyceridemia at high cardiovascular risk: Rationale and design of the Essence–TIMI 73b trial

Am Heart JPublished randomized, double-blind, placebo-controlled phase 3 trial

Study context

Population
Adults with either moderate hypertriglyceridemia (200–499 mg/dL) plus increased cardiovascular risk, or severe hypertriglyceridemia (≥500 mg/dL)randomized at 160 sites, 555 continued in the computed tomography angiography (CTA) substudy
Participants
1,478 adults
Planned comparison
Difference between each olezarsen dose group and pooled placebo
Primary endpoint
percent change in triglyceride levels
Follow-up
From baseline to 6 months
Methodological detailsrationale and design, coronary computed tomography angiography (CTA) substudy, 160 sites in North America and Europe
  • Rationale and design
  • Coronary computed tomography angiography (CTA) substudy
  • 160 sites in North America and Europe

No results yet. This paper sets out the design of a trial; its results are to come.

Baseline

Baseline characteristics · randomization

Median age (IQR), years
63 (IQR 56-69)
Women
39%
non-Hispanic White
71%
Diabetes
60%
Atherosclerotic cardiovascular disease
42%
Receiving lipid-lowering therapies
97%
On a statin
82%
Median baseline triglyceride level, mg/dL
249 (195-339)
Triglycerides ≥500 mg/dL at enrollment
9%

Coronary CTA substudy enrollment · baseline

Completed a baseline CTA
≈1000
Of those with a baseline CTA, had measurable noncalcified coronary plaque and continued in the substudy
555 (55%)

Original publication

Olezarsen in patients with hypertriglyceridemia at high cardiovascular risk: Rationale and design of the Essence–TIMI 73b trial. Am Heart J. Published 11 March 2025. doi:10.1016/j.ahj.2025.02.022

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