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

A Phase II Randomized, Double-Blind, Parallel-group, Placebo-Controlled Trial of SYH2068 Injection in Adults With Elevated Lipoprotein(a)

The purpose of this study is to evaluate the efficacy and safety of SYH2068 injection in patients with elevated lipoprotein(a).

Study Overview

• Status: Not yet recruiting
• Conditions: Adult Participants With Elevated Lipoprotein(a)
• Intervention / Treatment: Drug: SYH2068 Dose 1; Drug: SYH2068 Dose 2; Drug: SYH2068 Dose 3; Drug: Placebo

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 Type: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Clinical Trials Information Group officer; Phone Number: 0311-69085587; Email: ctr-contact@cspc.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male or female participants ≥18 years of age;
2. Elevated Lp(a);
3. 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;
4. Presence of ASCVD or ASCVD risk stratification assessed as moderate or high risk;
5. Participants are able to understand and cooperate to complete this study, voluntarily participate in this study, and sign the ICF.

Exclusion Criteria:

1. Diseases that significantly affect Lp(a) during screening period,
2. Major or unstable cardiovascular events occurring from 3 months before signing the ICF to randomization;
3. 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;
4. NYHA class III-IV at the time of signing the ICF or LVEF <40% during the screening period;
5. Type 1 diabetes or hereditary hemorrhagic disorder at screening;
6. History of malignant tumor or suspected malignancy within 5 years prior to screening;
7. Use of drugs affecting Lp(a) within the specified period before screening or expected to use during the study period;
8. Allergy to oligonucleotide drugs;
9. Received any other clinical study treatment within 3 months prior to screening or within 5 half-lives of the investigational drug;
10. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Administered by subcutaneous injection.
Experimental: SYH2068 Dose 1	Drug: SYH2068 Dose 1; Administered by subcutaneous injection.
Experimental: SYH2068 Dose 2	Drug: SYH2068 Dose 2; Administered by subcutaneous injection.
Experimental: SYH2068 Dose 3	Drug: SYH2068 Dose 3; Administered by subcutaneous injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage change in Lp(a) from baseline to Day 60~180	Day 60~180

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage change in Lp(a) from baseline to Day 30~540	Day 30~540
The percentage of participants achieving Lp(a) < 125 nmol/L and <75 nmol/L.	Day 30~540
Changes of LDL-C from baseline to Day 30~540	Day 30~540
Changes of ApoB from baseline to Day 30~540	Day 30~540
Incidence of TEAEs during the treatment	During treatment
ADA incidence	During treatment
The plasma concentration of SYH2068.	During treatment

Collaborators and Investigators

• Sponsor: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): July 30, 2026
• Primary Completion (Estimated): March 30, 2028
• Study Completion (Estimated): September 30, 2028

Study Registration Dates

• First Submitted: June 5, 2026
• First Submitted That Met QC Criteria: June 5, 2026
• First Posted (Actual): June 10, 2026

Study Record Updates

• Last Update Posted (Actual): June 10, 2026
• Last Update Submitted That Met QC Criteria: June 5, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: SYH2068-002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No