Prevention & lipidsRandomised controlled trial
Oral Muvalaplin for Lowering of Lipoprotein(a)
- Randomised controlled trial
- phase 2
- placebo-controlled
- double-blind
- 43 sites
Authors' conclusion
Muvalaplin reduced lipoprotein(a) measured using intact lipoprotein(a) and apolipoprotein(a)-based assays and was well tolerated.
Study context
- Population
- Lipoprotein(a) ≥175 nmol/L with atherosclerotic CVD, DM or familial hypercholesterolemia; 43 sites in Asia, Europe, Australia, Brazil and the US, 2022–2023
- Participants
- 233 participants
- Comparison
- Oral muvalaplin vs placebo
- 10 mg/dn = 34
- 60 mg/dn = 64
- 240 mg/dn = 68
- Placebon = 67reference
- Primary endpoint
- Placebo-adjusted percentage change from baseline in lipoprotein(a) molar concentration (intact lipoprotein(a) assay and apolipoprotein(a)-based assay)
- Follow-up
- Week 12
Primary result
As reported in the abstract
Placebo-adjusted reduction in lipoprotein(a)
Each group vs placeboPlacebo-adjusted reduction, % (95% CI)
10 mg/dintact lipoprotein(a) assay
47.6(35.1%–57.7%)
60 mg/dintact lipoprotein(a) assay
81.7(78.1%–84.6%)
240 mg/dintact lipoprotein(a) assay
85.8(83.1%–88.0%)
10 mg/dapolipoprotein(a)-based assay
40.4(28.3%–50.5%)
60 mg/dapolipoprotein(a)-based assay
70.0(65.0%–74.2%)
240 mg/dapolipoprotein(a)-based assay
68.9(63.8%–73.3%)
Secondary outcomes
| Outcome | reduction (%) (95% CI) | |
|---|---|---|
| Apolipoprotein B (reduction) — 10 mg/d vs Placebo · dose-dependent | 8.9 (−2.2% to 18.8%) | |
| Apolipoprotein B (reduction) — 60 mg/d vs Placebo · dose-dependent | 13.1 (4.4%–20.9%) | |
| Apolipoprotein B (reduction) — 240 mg/d vs Placebo · dose-dependent | 16.1 (7.8%–23.7%) | |
| −100102030Difference, % (linear scale) |
High-sensitivity C-reactive protein
- No change in high-sensitivity C-reactive protein
Safety
Safety and tolerability
- No safety or tolerability concerns at any dosage
Original publication
Oral Muvalaplin for Lowering of Lipoprotein(a). JAMA. Published 21 January 2025. doi:10.1001/jama.2024.24017
Summarised from the published abstract; every number is checked against it