LEROCHOL

Following a single subcutaneous administration, exposure to lerodalcibep-liga increased in a dose proportional manner over the dose range 75 to 300 mg of lerodalcibep-liga. Lerodalcibep-liga pharmacokinetics were observed at steady state in patients at the approved recommended dosage and are presented as mean (SD), unless otherwise specified. Lerodalcibep-liga maximum concentration (Cmax) is 31.4 (10.2) mcg/mL, and total systemic exposure (AUC0-tau) is 12,600 (5,190) (hrs*mcg/mL) following subcu...

The efficacy of LEROCHOL was evaluated in three randomized, double-blind, placebo-controlled trials that enrolled 2,017 adults with HeFH, clinical ASCVD, or increased risk for ASCVD, who were on a stable low-fat, low-cholesterol diet and maximally tolerated statin therapy and who required additional LDL-C lowering. Primary Hypercholesterolemia

Trial 1(NCT04797247) and

Trial 2(NCT04806893) were both multicenter, double-blind, randomized, placebo-controlled 52-week trials in which 1,844 adults with ASCVD or at increased risk for ASCVD events were randomized 2:1 to receive subcutaneous injectio...

Common adverse reactions occurring in ≥1% of patients treated with LEROCHOL were injection site reactions, nasopharyngitis, diarrhea, nausea and peripheral edema. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact LIB Therapeutics, Inc. at 1-877-2-LEROCHOL or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly co...

None. None. ( 4 )