NCT06568471 A Study on Efficacy and Safety of HST101 in Chinese Patients with Hypercholesterolemia
| NCT ID | NCT06568471 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Hasten Biopharmaceutical Co., Ltd. |
| Condition | Hypercholesterolemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 210 participants |
| Start Date | 2024-11-16 |
| Primary Completion | 2026-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 210 participants in total. It began in 2024-11-16 with a primary completion date of 2026-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
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
Contact & Investigator
Yong Huo
PRINCIPAL INVESTIGATOR
Peking University First Hospital
Frequently Asked Questions
Who can join the NCT06568471 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hypercholesterolemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06568471 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 210 participants.
Is NCT06568471 currently recruiting?
Yes, NCT06568471 is actively recruiting participants. Contact the research team at huoyong@263.net.cn for enrollment information.
Where is the NCT06568471 trial being conducted?
This trial is being conducted at Beijing, China, Beijing, China, Beijing, China, Beijing, China and 11 additional locations.
Who is sponsoring the NCT06568471 clinical trial?
NCT06568471 is sponsored by Hasten Biopharmaceutical Co., Ltd.. The principal investigator is Yong Huo at Peking University First Hospital. The trial plans to enroll 210 participants.