Phase 2
Completed N=281
Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) Reduction - DOSE Finding Study
Source: ClinicalTrials.gov NCT04270760 ↗Enrolled (actual)
281
Serious AEs
8.1%
Results posted
Aug 2023
Primary outcomePrimary: Percentage Change From Baseline in Lipoprotein(a) (Lp[a]) at Week 36 — -66.91; -93.78; -97.53; -96.89 Percentage Change in Lp(a) — p=<0.001
Summary
Evaluate the effect of olpasiran administered subcutaneously (SC) compared with placebo, on percent change from baseline in lipoprotein(a) (Lp[a]).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change From Baseline in Lipoprotein(a) (Lp[a]) at Week 36 |
-66.91; -93.78; -97.53; -96.89; 3.60 | <0.001 sig |
| SECONDARY Percentage Change From Baseline in Lp(a) at Week 48 |
-64.89; -92.54; -97.29; -82.36; 3.59 | <0.001 sig |
| SECONDARY Percentage Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 36 and Week 48 |
-17.425; -16.284; -16.733; -18.462; 6.234; -14.743 | <0.001 sig |
| SECONDARY Percentage Change From Baseline in Apolipoprotein (B) (ApoB) at Week 36 and Week 48 |
-11.496; -9.302; -10.241; -11.378; 7.394; -7.748 | <0.001 sig |
| SECONDARY Mean Serum Olpasiran Concentrations at Day 1, Week 24 and Week 48 |
0.00; 0.00; 0.00; 0.00; 12.3; 67.1 | — |
Eligibility Criteria
Inclusion Criteria
- Age 18 to 80 years
- Lipoprotein (a) > 150 nmol/L
- Evidence of atherosclerotic cardiovascular disease
Exclusion Criteria
- Severe renal dysfunction
- History or clinical evidence of hepatic dysfunction
- Malignancy within the last 5 years
- Currently receiving, or less than 3 months at Day 1 since receiving > 200 mg/day Niacin
Data sourced from ClinicalTrials.gov (NCT04270760). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.