NCT07640217Not yet recruitingPhase 2
A Phase II Randomized, Double-Blind, Parallel-group, Placebo-Controlled Trial of SYH2068 Injection in Adults With Elevated Lipoprotein(a)
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.0 sites120 target enrollmentStarted: July 30, 2026Last updated:
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Enrollment
- 120
Study Overview
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of SYH2068 injection in patients with elevated lipoprotein(a).
Detailed Description
This is a multicenter, randomized, double-blind, parallel, placebo-controlled Phase II clinical trial aimed at evaluating the efficacy, safety, immunogenicity, and pharmacokinetic characteristics of SYH2068 injection in adult participants with elevated lipoprotein(a). The study consists of a screening period and a treatment period.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female participants ≥18 years of age;
- •Elevated Lp(a);
- •Participants who have used lipid-lowering drugs continue to use a stable dose, and those who have not used do not start new lipid-lowering drugs;
- •Presence of ASCVD or ASCVD risk stratification assessed as moderate or high risk;
- •Participants are able to understand and cooperate to complete this study, voluntarily participate in this study, and sign the ICF.
Exclusion Criteria
- •Diseases that significantly affect Lp(a) during screening period,
- •Major or unstable cardiovascular events occurring from 3 months before signing the ICF to randomization;
- •Undergoing or expected to undergo peripheral arterial, coronary, or cerebrovascular revascularization surgery or other major surgery within 3 months prior to signing the ICF until randomization or during the study period;
- •NYHA class III-IV at the time of signing the ICF or LVEF <40% during the screening period;
- •Type 1 diabetes or hereditary hemorrhagic disorder at screening;
- •History of malignant tumor or suspected malignancy within 5 years prior to screening;
- •Use of drugs affecting Lp(a) within the specified period before screening or expected to use during the study period;
- •Allergy to oligonucleotide drugs;
- •Received any other clinical study treatment within 3 months prior to screening or within 5 half-lives of the investigational drug;
- •Female participants who are pregnant or breastfeeding at screening, or female / male participants who plan to conceive during the study and within 1 year after the last dose.
Investigators
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