drugset / Trial / NCT06568471

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

NCT06568471

Phase 3 Recruiting 210 enrolled Hasten Biopharmaceutical Co., Ltd.
RandomizedParallel-groupTriple-blindTreatment

Summary

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.

Timeline

Start
2024-11-16
Primary completion
2026-02
Completion
2026-05

Drugs

EvaluationDrugModalityDoseRoute
Subject lerodalcibep Protein / enzyme biologic 300 mg Subcutaneous