This randomized study is to assess LDL-C reductions at Week 12 with monthly (Q4W \[≤31 days\]) dosing of HST101 (lerodalcibep) 300 mg administered subcutaneously (SC) compared to placebo in patients with atherosclerotic cardiovascular disease (ASCVD) or very-high/high risk for ASCVD including Heterozygous familial hypercholesterolemia (HeFH) on a stable diet and oral LDL-C lowering drug therapy, followed by 36-week open-label treatment with subsequent 4-week follow-up for total 52-week long-term safety and efficacy evaluation.
Provision of written and signed informed consent form prior to any study-specific procedure;
Male or female participants ≥18 years of age at the screening visit;
Body weight ≥ 40 kg and body mass index (BMI) ≥18 and ≤35 kg/m2;
On a stable diet and lipid-lowering oral drugs (such as statins, ezetimibe or Hybutimibe, omega-3 compounds, fenofibrate, nicotinic acid, etc.) for at least 4 weeks prior to the first drug administration
Documented history of homozygous familial hypercholesterolemia (HoFH);
Estimated glomerular filtration rate (eGFR)<30 mL/min/1.73m2;
Active liver disease or hepatic dysfunction, history of liver transplant, and/or ALT or AST >2.5 × ULN at screening;
Poorly controlled thyroid disorder including hypothyroidism or hyperthyroidism;
Hasten Biopharmaceutical Co., Ltd.
Lead sponsor