RECRUITINGPhase 3INTERVENTIONAL
A Study on Efficacy and Safety of HST101 in Chinese Patients with Hypercholesterolemia
A Randomized, Double-blind, Placebo-controlled Phase 3 Clinical Study to Evaluate the Efficacy and Safety of HST101 in Chinese Patients with Hypercholesterolemia
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- Provision of written and signed willing to sign a consent form 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 waiting period after previous treatment of ≥6 weeks after the last dose; for those on 300 mg or 420 mg Q4W, the waiting period after previous treatment 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.
Who Should NOT Join This Trial:
- 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;
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DRUG
Lerodalcibep
PCSK9 inhibitor
DRUG
matching placebo
placebo
Locations (18)
Beijing Anzhen Hospital of Capital Medical University
Beijing, Beijing Municipality, China
Beijing Luhe Hospital, Capital Medical Univeristy
Beijing, Beijing Municipality, China
Beijing Tsinghua Changgeng Hospital
Beijing, Beijing Municipality, China
Fuwai Hospital, CAMS & PUMC
Beijing, Beijing Municipality, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Shijiazhuang People's Hospital
Shijiazhuang, Hebei, China
Daqingshi People's Hospital
Daqing, Heilingjiang, China
The 2nd Xiangya Hospital of Central South University
Changsha, Hunan, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
Nanchang People's Hospital
Nanchang, Jiangxi, China
Binzhou Medical University Hospital
Binzhou, Shandong, China
Heze Municipal Hospital
Heze, Shandong, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Zibo Municipal Hospital
Zibo, Shandong, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Tianjin People's Hospital
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital of Wenzhou Medical Univesity
Wenzhou, Zhejiang, China
Peking University First Hospital
Beijing, China