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Tests treatment safety and results for Hypercholesterolemia
Official title A Study on Efficacy and Safety of HST101 in Chinese Patients with Hypercholesterolemia
ClinicalTrials.gov ID: NCT06568471
What this study is testing
What is Lerodalcibep?
Lerodalcibep is an investigational medicine, given as a monthly injection under the skin, being studied as a potential treatment for hypercholesterolemia.
Also referred to as HST101, LIB003.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
- 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...
You likely can't join 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) ≥...
- Serious arrhythmia, MI, unstable angina pectoris, PCI, CABG, implantable cardioverter defibrillator, aortic valve surgery or stroke within 3 months...
See the full eligibility 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
- Guangzhou, Guangdong, China
- Shijiazhuang, Hebei, China
- Daqing, Heilingjiang, China
- Changsha, Hunan, China
- Nanchang, Jiangxi, China
- Binzhou, Shandong, China
- Heze, Shandong, China
- Jinan, Shandong, China
- Zibo, Shandong, China
- Chengdu, Sichuan, China
- Tianjin, Tianjin Municipality, China
- Wenzhou, Zhejiang, China
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China; Guangzhou, Guangdong, China; Shijiazhuang, Hebei, China; Daqing, Heilingjiang, China; Changsha, Hunan, China; Nanchang, Jiangxi, China and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.