A Phase II Clinical Study of SYH2068 Injection in Adults With Elevated Lipoprotein(a)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SYH2068 Dose 1, SYH2068 Dose 2, SYH2068 Dose 3, Placebo.
- Who it may be relevant to
- Registry conditions: Adult Participants With Elevated Lipoprotein(a). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Phase II Randomized, Double-Blind, Parallel-group, Placebo-Controlled Trial of SYH2068 Injection in Adults With Elevated Lipoprotein(a)
Overview
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.
Interventions
- Drug SYH2068 Dose 1
Administered by subcutaneous injection. - Drug SYH2068 Dose 2
Administered by subcutaneous injection. - Drug SYH2068 Dose 3
Administered by subcutaneous injection. - Drug Placebo
Administered by subcutaneous injection.
Primary outcome measures
- Percentage change in Lp(a) from baseline to Day 60~180 [Time frame: Day 60~180]
Secondary outcome measures (7)
- Percentage change in Lp(a) from baseline to Day 30~540 [Time frame: Day 30~540]
- The percentage of participants achieving Lp(a) < 125 nmol/L and <75 nmol/L. [Time frame: Day 30~540]
- Changes of LDL-C from baseline to Day 30~540 [Time frame: Day 30~540]
- Changes of ApoB from baseline to Day 30~540 [Time frame: Day 30~540]
- Incidence of TEAEs during the treatment [Time frame: During treatment]
- ADA incidence [Time frame: During treatment]
- The plasma concentration of SYH2068. [Time frame: During treatment]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07640217 · SYH2068-002