Status:
RECRUITING
A Study on Efficacy and Safety of HST101 in Chinese Patients with Hypercholesterolemia
Lead Sponsor:
Hasten Biopharmaceutical Co., Ltd.
Conditions:
Hypercholesterolemia
Dyslipidemias
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 w...
Detailed Description
This is a multi-center, randomized, double-blind, placebo-controlled Phase 3 study. Participants who fulfill the inclusion and exclusion criteria will be enrolled at up to 35 study sites in mainland C...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT06568471
Start Date
November 16 2024
End Date
May 1 2026
Last Update
February 6 2025
Active Locations (18)
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1
Beijing Anzhen Hospital of Capital Medical University
Beijing, Beijing Municipality, China
2
Beijing Luhe Hospital, Capital Medical Univeristy
Beijing, Beijing Municipality, China
3
Beijing Tsinghua Changgeng Hospital
Beijing, Beijing Municipality, China
4
Fuwai Hospital, CAMS & PUMC
Beijing, Beijing Municipality, China