Evaluating HST101 for lowering cholesterol in Chinese patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 clinical trial aims to assess the efficacy and safety of HST101 (lerodalcibep), a PCSK9 inhibitor, in reducing LDL cholesterol levels in Chinese patients with hypercholesterolemia, particularly those at high risk for atherosclerotic cardiovascular disease. The study involves a randomized, double-blind, placebo-controlled design over a total duration of 55 weeks, including a 12-week initial treatment phase followed by a 36-week open-label phase. Participants will receive either HST101 or a placebo during the initial phase, with all transitioning to HST101 in the open-label phase. The study will take place across multiple centers in mainland China.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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
* LDL-C≥1.8 mmol/L (70 mg/dL) and TG≤4.52 mmol/L (400 mg/dL) at screening for ASCVD patients or those at very (ultra)-high risk for ASCVD, including patients with HeFH; LDL-C ≥ 2.6 mmol/L (100 mg/dL) and TG ≤ 4.52 mmol/L (400 mg/dL) at screening for patients at high-risk for ASCVD including patients with HeFH;
* Patients on a PCSK9 mAb at a dose of 75 mg, 140 mg, or 150 mg Q2W must undergo a washout period of ≥6 weeks after the last dose; for those on 300 mg or 420 mg Q4W, the washout period is ≥10 weeks following last dose;
* Female of childbearing potential must have a negative pregnancy test at the last screening visit and consent to use highly effective contraceptives during the trial and 3 months after the last dose of investigational drug.

Exclusion Criteria:

* 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;
* Poorly controlled Type 1 or Type 2 diabetes mellitus defined as fasting blood glucose ≥11.0 mmol/L (200 mg/dL) and glycosylated hemoglobin (HbA1c) ≥ 9%;
* Serious arrhythmia, MI, unstable angina pectoris, PCI, CABG, implantable cardioverter defibrillator, aortic valve surgery or stroke within 3 months prior to the first dose;
* Planned cardiac surgery or revascularization during the study period;
* New York Heart Association (NYHA) Class III-IV heart failure;
* Pregnant or lactating women;
* Poorly controlled hypertension (SBP≥160 mmHg or DBP≥100 mmHg in a sitting position)
* Unexplained creatine kinase (CK) \> 5 x ULN (retested once is needed if suspected to be related to excessive exercise or abnormal activity);
* LDL apheresis or plasma exchange within 2 months prior to the first dose;
* HIV, Treponema pallidum, or HCV antibody test positive, or HBV-DNA \>ULN at screening;
* History of prescription drug abuse, illicit drug use or alcohol abuse within 6 months prior to screening;
* History of any major drug allergy, including allergy to protein biologics;
* Participate another clinical trial within 30 days or less than 5 half-lifes (drug) before screening, whichever is longer

Where it's running

• Beijing Anzhen Hospital of Capital Medical University
  Beijing, Beijing Municipality, China Recruiting
• Beijing Luhe Hospital, Capital Medical Univeristy
  Beijing, Beijing Municipality, China Recruiting
• Beijing Tsinghua Changgeng Hospital
  Beijing, Beijing Municipality, China Recruiting
• Fuwai Hospital, CAMS & PUMC
  Beijing, Beijing Municipality, China Recruiting
• Guangdong Provincial People's Hospital
  Guangzhou, Guangdong, China Recruiting
• Shijiazhuang People's Hospital
  Shijiazhuang, Hebei, China Recruiting

Study contacts

• Principal investigator: Yong Huo — Peking University First Hospital
• Study coordinator: Yong Huo
• Email: huoyong@263.net.cn
• Phone: +86 13901333060

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.