A Study of Olezarsen (Formerly Known as AKCEA-APOCIII-LRx) in Adults With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease (Established or at Increased Risk for), and/or With Severe Hypertriglyceridemia
Summary
The purpose of the study was to evaluate the effect of olezarsen on percent change in fasting triglyceride (TG) levels compared to placebo at Months 6 and 12 and the proportion of participants who achieve different thresholds in fasting TG. Other objectives were to evaluate the effect of olezarsen on percent change in fasting apolipoprotein C-III (apoC-III), very low-density lipoprotein cholesterol (VLDL-C), remnant cholesterol, non-high-density lipoprotein cholesterol (non-HDL-C), HDL-C, total cholesterol (TC), apolipoprotein B (apoB), low-density lipoprotein cholesterol (LDL-C), and apolipoprotein A-1 (apoA-1).
Timeline
- Start
- 2022-05-09
- Primary completion
- 2023-03-22
- Completion
- 2023-12-21
Outcome
Met primary endpoint
paper The 50-mg and 80-mg doses of olezarsen reduced triglyceride levels by 49.3 percentage points and 53.1 percentage points, respectively, as compared with placebo (P<0.001 for both comparisons). PMID 38587249 ↗
registry analysis (superiority test); Placebo vs Olezarsen 50 mg; p <0.0001; Least Squares (LS) Mean Difference -49.28 (95% CI -59.02 to -39.54); ANCOVA; NCT05355402 ↗
registry analysis (superiority test); Placebo vs Olezarsen 80 mg; p <0.0001; LS Mean Difference -53.15 (95% CI -62.92 to -43.38); ANCOVA; NCT05355402 ↗
release “Announced positive topline results from the Essence study in people with moderately elevated triglycerides; achieved primary and all key secondary endpoints” ionis.com ↗