Phase 3 Study of HST101 Lerodalcibep Given by Injection Every 4 Weeks to Treat Chinese Adults with High Cholesterol and Heart Disease Risk

What this Trial Is About

Researchers are evaluating the effects of HST101 lerodalcibep, a PCSK9 inhibitor, on lowering LDL cholesterol in patients with atherosclerotic cardiovascular disease or those at very high or high risk for this condition, including patients with heterozygous familial hypercholesterolemia. This is a randomized, double-blind, placebo-controlled Phase 3 study conducted in multiple centers in mainland China to assess the safety and efficacy of HST101 over a one-year period. Participants will be randomly assigned in a 21 ratio to receive either 300 mg of HST101 or a matching placebo by subcutaneous injection every four weeks for 12 weeks. After this initial phase, all participants will receive HST101 in an open-label treatment for 36 weeks at the same dosing schedule, followed by a 4-week safety follow-up. This study includes a screening period lasting up to 3 weeks before treatment begins. During the study, participants will have regular assessments to monitor LDL cholesterol changes, free PCSK9 levels, other lipid parameters, and any treatment-related side effects. The primary focus is the change in LDL cholesterol at week 12 compared to placebo. Safety and efficacy will be observed throughout the 52-week treatment period, including monitoring for adverse events. The total study duration for participants is up to 55 weeks, including screening and follow-up.

A Study on Efficacy and Safety of HST101 in Chinese Patients with Hypercholesterolemia