Prevention & lipidsRandomised controlled trial
Safety and Lipid-Lowering Efficacy of Inclisiran Monotherapy in Patients Without Atherosclerotic Cardiovascular Disease (ASCVD)
- Randomised controlled trial
- phase 3
- double-blind
- multicentre
- placebo- and active-comparator controlled
- 2:1:1 randomisation
Twice-yearly inclisiran dosing not evaluated beyond the first 180 days
Authors' conclusion
V-Mono demonstrates for the first time that in patients not receiving lipid-lowering therapy, inclisiran as monotherapy, is superior to both placebo and ezetimibe in reducing LDL-C levels over a 6-month follow-up period and was well tolerated.
Study context
- Population
- Adults aged 18–75 years without ASCVD, DM or familial hypercholesterolemia, low-density lipoprotein cholesterol (LDL-C) 100–190 mg/dL, 10-year ASCVD risk <7.5%, not on lipid-lowering therapy
- Participants
- 350 adults
- Comparison
- Inclisiran monotherapy vs ezetimibe vs placebo
- Inclisirann = 174
- Ezetimiben = 89reference
- Placebon = 87reference
- Primary endpoint
- Percentage change in LDL-C from baseline
- Follow-up
- Day 150
Primary result
As reported in the abstract
Placebo
1.4
mean · %
Ezetimibe
−11.2
mean · %
Inclisiran
−46.5
mean · %
- Inclisiran vs Placebo
- difference −47.9 %; P < 0.0001
- Inclisiran vs Ezetimibe
- difference −35.4 %; P < 0.0001
Secondary outcomes
Other lipid and lipoprotein(a) levels
- Inclisiran showed favorable improvements in other lipid and lipoprotein(a) levels
Safety
Tolerability
- Inclisiran well tolerated, no new safety concerns
Original publication
Safety and Lipid-Lowering Efficacy of Inclisiran Monotherapy in Patients Without ASCVD. J Am Coll Cardiol. Published 5 May 2025. doi:10.1016/j.jacc.2025.04.049
Summarised from the published abstract; every number is checked against it