Prevention & lipidsRandomised controlled trial
Recaticimab Monotherapy for Nonfamilial Hypercholesterolemia and Mixed Hyperlipemia
- Randomised controlled trial
- double-blind
- placebo-controlled
- phase 3
- multicentre (59 sites in China)
Authors' conclusion
Recaticimab monotherapy yielded significant LDL-C reductions and showed comparable safety vs placebo in patients with nonfamilial hypercholesterolemia and mixed hyperlipemia at low-to-moderate ASCVD risk, even with an infrequent dosing interval up to Q12W.
Study context
- Population
- Nonfamilial hypercholesterolemia and mixed hyperlipemia at low-to-moderate atherosclerotic cardiovascular disease (ASCVD) risk (fasting LDL-C ≥2.6 to <4.9 mmol/L, TG ≤5.6 mmol/L, 10-year ASCVD risk <10%), on lipid-lowering diet
- Participants
- 703 participants
- Comparison
- Recaticimab vs placebo
- Recaticimab 150 mg Q4Wn = 157
- Recaticimab 300 mg Q8Wn = 156
- Recaticimab 450 mg Q12Wn = 155
- Primary endpoint
- Percentage change in LDL-C from baseline
- Follow-up
- Week 12 for 150 mg Q4W and 450 mg Q12W; week 16 for 300 mg Q8W
Primary result
As reported in the abstract
LDL-C reduction vs placebo
Each group vs placeboDifference, % (95% CI)P value
150 mg Q4W
49.6(44.2%–54.9%)
P < 0.0001300 mg Q8W
52.8(48.3%–57.2%)
P < 0.0001450 mg Q12W
45.0(41.0%–49.0%)
P < 0.0001Further findings
Efficacy through week 24 (incl. placebo switched to recaticimab) · 24 weeks
- Both 24-week recaticimab and 12- or 8-week recaticimab switched from placebo were effective
Safety
Safety vs placebo
- Safety with recaticimab comparable to placebo
Most common treatment-related AE: injection site reaction · 24 weeks of recaticimab
- Injection site reaction
- n = 23 [4.9%]
Original publication
Recaticimab Monotherapy for Nonfamilial Hypercholesterolemia and Mixed Hyperlipemia. J Am Coll Cardiol. Published 9 October 2024. doi:10.1016/j.jacc.2024.07.035
Summarised from the published abstract; every number is checked against it