drugset / Trial / NCT06568471
A Study on Efficacy and Safety of HST101 in Chinese Patients with Hypercholesterolemia
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | lerodalcibep | Protein / enzyme biologic | 300 mg | Subcutaneous |