The Off-Treatment Effects of Olpasiran on Lipoprotein(a) Lowering: OCEAN(a)-DOSE Extension Period Results
Authors' conclusion
Olpasiran is a potent siRNA with prolonged effects on Lp(a) lowering. Participants receiving doses ≥75 mg Q12W sustained a ∼40% to 50% reduction in Lp(a) levels close to 1 year after the last dose.
Study context
- Population
- Atherosclerotic CVD with Lp(a) >150 nmol/L276 entered off-treatment follow-up
- Participants
- 281 participants
- Comparison
- Olpasiran vs placebo, after discontinuation
- Primary endpoint
- Timing of return of Lp(a) to baseline after discontinuation of olpasiran, and longer-term safety
- Follow-up
- Last dose week 36; off-treatment after week 48 for ≥24 weeks
Methodological detailsphase 2, dose-finding, placebo-controlled, extended off-treatment follow-up
- Phase 2
- Dose-finding
- Placebo-controlled
- Extended off-treatment follow-up
Primary result
As reported in the abstract
Off-treatment placebo-adjusted mean percent change from baseline in Lp(a) · 60, 72, 84 and 96 weeks
| Group | Week 60 | Week 72 | Week 84 | Week 96 |
|---|---|---|---|---|
| 75 mg Q12W | −76.2% | −53.0% | −44.0% | −27.9% |
| 225 mg Q12W | −84.4% | −61.6% | −52.2% | −36.4% |
Week 60
75 mg Q12W−76.2%
225 mg Q12W−84.4%
Week 72
75 mg Q12W−53.0%
225 mg Q12W−61.6%
Week 84
75 mg Q12W−44.0%
225 mg Q12W−52.2%
Week 96
75 mg Q12W−27.9%
225 mg Q12W−36.4%
Further findings
Median study exposure (treatment + off-treatment)
- Median study exposure 86 weeks (Q1-Q3: 79-99 weeks)
Safety
Safety during extension follow-up
- No new safety concerns identified
Original publication
The Off-Treatment Effects of Olpasiran on Lipoprotein(a) Lowering: OCEAN(a)-DOSE Extension Period Results. J Am Coll Cardiol. Published 27 August 2024. doi:10.
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