A Phase II Clinical Study of SYH2068 Injection in Adults With Elevated Lipoprotein(a)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
About this trial
The purpose of this study is to evaluate the efficacy and safety of SYH2068 injection in patients with elevated lipoprotein(a).
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- SYH2068 Dose 1
- SYH2068 Dose 2
- SYH2068 Dose 3
- Placebo
Treatment groups
120 Participants
are divided into 4 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov