Schema for the Essence-TIMI 73b trial. Credit score: American Coronary heart Journal (2025). DOI: 10.1016/j.ahj.2025.02.022
Olezarsen decreased ranges of triglycerides in contrast with placebo in sufferers with reasonable hypertriglyceridemia and elevated cardiovascular threat, in response to a late-breaking trial introduced in a Sizzling Line session on the ESC Congress 2025 and concurrently printed within the American Coronary heart Journal.
“High levels of triglycerides are an important risk factor for atherosclerotic cardiovascular disease (ASCVD) and yet the effects of current therapies are modest,” defined principal investigator, Dr. Brian Bergmark from the TIMI Examine Group, Brigham and Ladies’s Hospital, Harvard Medical College, Boston, U.S.
He continued, “Olezarsen targets the mRNA of apolipoprotein C-III, which inhibits triglyceride clearance. Olezarsen has been shown to lower triglyceride levels in small Phase II trials and in patients with very high triglyceride levels. We investigated the efficacy and safety of olezarsen in patients with moderate hypertriglyceridemia at high ASCVD risk in the ESSENCE-TIMI 73b trial.”
The placebo-controlled, double-blind Section III ESSENCE-TIMI 73b trial was performed at 160 websites in North America and Europe. The trial included grownup sufferers with reasonable hypertriglyceridemia (triglycerides 150–499 mg/dL) and elevated cardiovascular threat as a result of a longtime prognosis of ASCVD or elevated ASCVD threat on account of sort 2 diabetes mellitus and age ≥55 years.
Sufferers had been anticipated to be on optimized steady low-density lipoprotein-cholesterol (LDL-C)-lowering remedy at enrollment. The ESSENCE-TIMI 73b trial additionally included sufferers with extreme hypertriglyceridemia (triglycerides ≥500 mg/dL). The first analytic cohort was sufferers with reasonable hypertriglyceridemia as sufferers with extreme hypertriglyceridemia are being studied in devoted, separate trials.
The first evaluation inhabitants included 1,349 sufferers with reasonable hypertriglyceridemia and elevated cardiovascular threat who had been randomized to olezarsen 50 mg (n=254), olezarsen 80 mg (n=766) or placebo (n=329) given each 4 weeks by way of subcutaneous injection for 12 months. The first endpoint was the % change from baseline in triglyceride ranges at six months in contrast with placebo.
The first evaluation inhabitants had a median age of 64 years and 40% had been girls. The median triglyceride degree at baseline was 238.5 mg/dL.
At six months, olezarsen considerably diminished ranges of triglycerides: the placebo-adjusted least-squares imply distinction in % change from baseline was −58.4 proportion factors for olezarsen 50 mg and −60.6 proportion factors for olezarsen 80 mg (each p
Within the placebo group, 12.5% of sufferers had triglyceride ranges
Olezarsen considerably diminished ranges of different lipoproteins—remnant ldl cholesterol, non-high-density lipoprotein ldl cholesterol and apolipoprotein B—with no important impact on LDL-C.
The incidence of great opposed occasions appeared comparable: 9% with olezarsen 50 mg, 14% with olezarsen 80 mg and 11% with placebo. Liver transaminase elevations to any diploma above the higher restrict of the traditional vary had been extra frequent with olezarsen 50 mg (34.2%) and olezarsen 80 mg (38.3%) than with placebo (17.6%) (each p
Summarizing, Physician Bergmark mentioned, “In a population with moderate hypertriglyceridemia and elevated cardiovascular risk, monthly olezarsen resulted in substantial triglyceride lowering greater than would be expected from currently available therapies, with more than 80% of patients treated with olezarsen achieving normal triglyceride levels.”
Extra data:
Brian A. Bergmark et al, Olezarsen in sufferers with hypertriglyceridemia at excessive cardiovascular threat: Rationale and design of the Essence–TIMI 73b trial, American Coronary heart Journal (2025). DOI: 10.1016/j.ahj.2025.02.022
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Olezarsen reduces ranges of the blood fats, triglycerides, in sufferers at excessive cardiovascular threat: Scientific trial (2025, September 1)
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