The VICTORION-Mono trial tested inclisiran — a twice-yearly injectable siRNA drug — as a standalone therapy in 350 adults without cardiovascular disease or diabetes. Participants had moderately elevated LDL (average 135 mg/dL) and low 10-year heart disease risk. After 6 months, inclisiran reduced LDL by 46.5% versus a 1.4% change with placebo and just 11.2% with ezetimibe. The drug also lowered PCSK9 and lipoprotein(a) levels. The trial included a notably diverse population — over 60% women and nearly 40% Hispanic/Latino participants. Inclisiran was well tolerated with no new safety signals, marking the first evidence of its effectiveness as monotherapy in a primary prevention setting.
