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A Phase II Clinical Study of SYH2068 Injection in Adults With Elevated Lipoprotein(a)

ConditionAdult Participants 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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • SYH2068 Dose 1

    Drug

    Administered by subcutaneous injection.

  • SYH2068 Dose 2

    Drug

    Administered by subcutaneous injection.

  • SYH2068 Dose 3

    Drug

    Administered by subcutaneous injection.

  • Placebo

    Drug

    Administered by subcutaneous injection.

Treatment groups

120 Participants
are divided into 4 treatment groups
Group A: SYH2068 Dose 1Experimental treatment 1 intervention
Group B: SYH2068 Dose 2Experimental treatment 1 intervention
Group C: SYH2068 Dose 3Experimental treatment 1 intervention
Group D: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percentage change in Lp(a) from baseline to Day 60~180

Time frame
Day 60~180

Secondary outcomes

1

Percentage change in Lp(a) from baseline to Day 30~540

Time frame
Day 30~540
2

The percentage of participants achieving Lp(a) < 125 nmol/L and <75 nmol/L.

Time frame
Day 30~540
3

Changes of LDL-C from baseline to Day 30~540

Time frame
Day 30~540
4

Changes of ApoB from baseline to Day 30~540

Time frame
Day 30~540

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: