Design and rationale of the CORE-TIMI 72a and CORE2-TIMI 72b trials of olezarsen in patients with severe hypertriglyceridemia
Study context
- Population
- Patients with severe hypertriglyceridemia (HTG), defined as a serum triglyceride (TG) concentration ≥500 mg/dlrandomized, per trial · CORE-TIMI 72a 617 · CORE2-TIMI 72b 446
- Planned comparison
- Olezarsen or matching placebo
- Primary endpoint
- percent change in TGs from baseline to 6 months compared with placebo
- Follow-up
- 6 months
Methodological detailsrandomized in a 2:1 fashion, matching placebo, pooled analyses
- Randomized in a 2:1 fashion
- Matching placebo
- Pooled analyses
No results yet. This paper sets out the design of a trial; its results are to come.
Baseline
Baseline characteristics
Median age CORE-TIMI 72a 54 years · CORE2-TIMI 72b 55 years
Women
Baseline TGs CORE-TIMI 72a 836 mg/dl · CORE2-TIMI 72b 749 mg/dl
Events
| Outcome | CORE-TIMI 72a | CORE2-TIMI 72b |
|---|---|---|
| Enrollment in the hepatic MRI substudy | 129 | 204 |
- Enrollment in the hepatic MRI substudy — total enrolled in hepatic MRI substudy
- 333
Original publication
Design and rationale of the CORE-TIMI 72a and CORE2-TIMI 72b trials of olezarsen in patients with severe hypertriglyceridemia. Am Heart J. Published 9 March 2025. doi:10.
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