A Study on Efficacy and Safety of HST101 in Chinese Patients With Hypercholesterolemia
- Conditions
- HypercholesterolemiaDyslipidemiasPrimary HypercholesterolemiaHeterozygous Familial HypercholesterolemiaHyperlipidemiaMixedMetabolic DiseaseASCVD
- Registration Number
- NCT06568471
- Lead Sponsor
- Hasten Biopharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 210
Inclusion Criteria:<br><br> - Provision of written and signed informed consent form prior to any study-specific<br> procedure;<br><br> - Male or female participants =18 years of age at the screening visit;<br><br> - Body weight = 40 kg and body mass index (BMI) =18 and =35 kg/m2;<br><br> - On a stable diet and lipid-lowering oral drugs (such as statins, ezetimibe or<br> Hybutimibe, omega-3 compounds, fenofibrate, nicotinic acid, etc.) for at least 4<br> weeks prior to the first drug administration<br><br> - LDL-C=1.8 mmol/L (70 mg/dL) and TG=4.52 mmol/L (400 mg/dL) at screening for ASCVD<br> patients or those at very (ultra)-high risk for ASCVD, including patients with HeFH;<br> LDL-C = 2.6 mmol/L (100 mg/dL) and TG = 4.52 mmol/L (400 mg/dL) at screening for<br> patients at high-risk for ASCVD including patients with HeFH;<br><br> - Patients on a PCSK9 mAb at a dose of 75 mg, 140 mg, or 150 mg Q2W must undergo a<br> washout period of =6 weeks after the last dose; for those on 300 mg or 420 mg Q4W,<br> the washout period is =10 weeks following last dose;<br><br> - Female of childbearing potential must have a negative pregnancy test at the last<br> screening visit and consent to use highly effective contraceptives during the trial<br> and 3 months after the last dose of investigational drug.<br><br>Exclusion Criteria:<br><br> - Documented history of homozygous familial hypercholesterolemia (HoFH);<br><br> - Estimated glomerular filtration rate (eGFR)<30 mL/min/1.73m2;<br><br> - Active liver disease or hepatic dysfunction, history of liver transplant, and/or ALT<br> or AST >2.5 × ULN at screening;<br><br> - Poorly controlled thyroid disorder including hypothyroidism or hyperthyroidism;<br><br> - Poorly controlled Type 1 or Type 2 diabetes mellitus defined as fasting blood<br> glucose =11.0 mmol/L (200 mg/dL) and glycosylated hemoglobin (HbA1c) = 9%;<br><br> - Serious arrhythmia, MI, unstable angina pectoris, PCI, CABG, implantable<br> cardioverter defibrillator, aortic valve surgery or stroke within 3 months prior to<br> the first dose;<br><br> - Planned cardiac surgery or revascularization during the study period;<br><br> - New York Heart Association (NYHA) Class III-IV heart failure;<br><br> - Pregnant or lactating women;<br><br> - Poorly controlled hypertension (SBP=160 mmHg or DBP=100 mmHg in a sitting position)<br><br> - Unexplained creatine kinase (CK) > 5 x ULN (retested once is needed if suspected to<br> be related to excessive exercise or abnormal activity);<br><br> - LDL apheresis or plasma exchange within 2 months prior to the first dose;<br><br> - HIV, Treponema pallidum, or HCV antibody test positive, or HBV-DNA >ULN at<br> screening;<br><br> - History of prescription drug abuse, illicit drug use or alcohol abuse within 6<br> months prior to screening;<br><br> - History of any major drug allergy, including allergy to protein biologics;<br><br> - Participate another clinical trial within 30 days or less than 5 half-lifes (drug)<br> before screening, whichever is longer
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method LDL-C change compared to Placebo;Mean LDL-C change at Weeks 10 and 12 compared to Placebo
- Secondary Outcome Measures
Name Time Method LDL-C change over time;Free PCSK9 change;Other Lipid parameters change;Percentage of patients achieving LDL-C goals recommended by 2023 Chinese guideline;Incidence of treatment-emergent adverse events