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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Hypercholesterolemia, Dyslipidemias, Primary Hypercholesterolemia, Heterozygous Familial Hypercholesterolemia, Hyperlipidemia; Mixed, Metabolic Disease, ASCVD

In brief

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.

Key facts

Study ID

NCT06568471

Run by

Hasten Biopharmaceutical Co., Ltd.

People needed

210

Starts

2024-11-16

Expected to finish

2026-05-01

Last updated by the study team

2025-02-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• Beijing Anzhen Hospital of Capital Medical University — Beijing, Beijing Municipality, China (enrolling)
• Beijing Luhe Hospital, Capital Medical Univeristy — Beijing, Beijing Municipality, China (enrolling)
• Beijing Tsinghua Changgeng Hospital — Beijing, Beijing Municipality, China (enrolling)
• Fuwai Hospital, CAMS & PUMC — Beijing, Beijing Municipality, China (enrolling)
• Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (enrolling)
• Shijiazhuang People's Hospital — Shijiazhuang, Hebei, China (enrolling)
• Daqingshi People's Hospital — Daqing, Heilingjiang, China (enrolling)
• The 2nd Xiangya Hospital of Central South University — Changsha, Hunan, China (enrolling)
• The Third Xiangya Hospital of Central South University — Changsha, Hunan, China (enrolling)
• Nanchang People's Hospital — Nanchang, Jiangxi, China (enrolling)
• Binzhou Medical University Hospital — Binzhou, Shandong, China (enrolling)
• Heze Municipal Hospital — Heze, Shandong, China (enrolling)
• Qilu Hospital of Shandong University — Jinan, Shandong, China (enrolling)
• Zibo Municipal Hospital — Zibo, Shandong, China (enrolling)
• West China Hospital of Sichuan University — Chengdu, Sichuan, China (enrolling)
• Tianjin People's Hospital — Tianjin, Tianjin Municipality, China (enrolling)
• The First Affiliated Hospital of Wenzhou Medical Univesity — Wenzhou, Zhejiang, China (enrolling)
• Peking University First Hospital — Beijing, China

Full record on ClinicalTrials.gov

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