Prevention & lipidsRandomised controlled trial
Plozasiran, an RNA Interference Agent Targeting Apolipoprotein C3 (APOC3), for Mixed Hyperlipidemia
- Randomised controlled trial
- phase 2b
- double-blind
- placebo-controlled
- 48-week
- 3:1 randomisation within each of four cohorts
Authors' conclusion
In this randomized, controlled trial involving participants with mixed hyperlipidemia, plozasiran, as compared with placebo, significantly reduced triglyceride levels at 24 weeks.
Study context
- Population
- Mixed hyperlipidemia (TG 150–499 mg/dL and LDL-C ≥70 mg/dL or non-HDL cholesterol ≥100 mg/dL)
- Participants
- 353 participants
- Comparison
- Plozasiran vs placebo
- Primary endpoint
- Percent change in fasting TG level
- Follow-up
- Week 24
Primary result
As reported in the abstract
Fasting TG, LS mean percent change from baseline vs placebo
Each group vs placeboDifference, percentage points (95% CI)P value
10-mg-quarterly
−49.8(−59.0 to −40.6)
P < 0.00125-mg-quarterly
−56.0(−65.1 to −46.8)
P < 0.00150-mg-quarterly
−62.4(−71.5 to −53.2)
P < 0.00150-mg-half-yearly
−44.2(−53.4 to −35.0)
P < 0.001Safety
| Outcome | Values |
|---|---|
| Worsening glycemic control | Placebo 10% · 10-mg-quarterly 12% · 25-mg-quarterly 7% · 50-mg-quarterly 20% · 50-mg-half-yearly 21% |
Original publication
Plozasiran, an RNA Interference Agent Targeting APOC3, for Mixed Hyperlipidemia. N Engl J Med. Published 28 May 2024. doi:10.1056/nejmoa2404143
Summarised from the published abstract; every number is checked against it