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

Launched by HASTEN BIOPHARMACEUTICAL CO., LTD. · Aug 21, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called HST101, which is designed to help lower cholesterol levels in patients with high cholesterol and related heart conditions. Specifically, the trial aims to see how effective HST101 is at reducing low-density lipoprotein cholesterol (LDL-C) after 12 weeks of treatment compared to a placebo (a dummy treatment that has no active ingredients). Eligible participants include adults aged 18 and older who have been following a stable diet and taking oral cholesterol-lowering medications for at least four weeks. They must have specific cholesterol levels and be at high risk for cardiovascular issues.

Participants in this study can expect to receive either the HST101 medication or a placebo for the first 12 weeks, followed by an additional 36 weeks of open-label treatment where everyone will receive the active medication. The total duration of the study is 52 weeks, during which researchers will monitor the safety and effectiveness of the treatment. It's important to note that certain health conditions may exclude someone from participating, such as serious liver problems, uncontrolled diabetes, or recent heart issues. This trial is currently recruiting participants, and those interested should discuss their eligibility with their healthcare provider.

Gender

ALL

Eligibility criteria

• 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