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

NCT06568471 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2025-02-06

No results posted yet for this study

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.

Conditions

  • Hypercholesterolemia
  • Dyslipidemias
  • Primary Hypercholesterolemia
  • Heterozygous Familial Hypercholesterolemia
  • Hyperlipidemia; Mixed
  • Metabolic Disease
  • ASCVD

Interventions

DRUG

Lerodalcibep

PCSK9 inhibitor

DRUG

matching placebo

placebo

Sponsors & Collaborators

  • Hasten Biopharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yong Huo · Peking University First Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-16
Primary Completion
2026-02-28
Completion
2026-05-31
FDA Drug
Yes

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06568471 on ClinicalTrials.gov