Adult Participants With Elevated Lipoprotein(a)Phase 2NCT07640217
A Phase II Clinical Study of SYH2068 Injection in Adults With Elevated Lipoprotein(a)
A Phase 2 study testing SYH2068 Dose 1, SYH2068 Dose 2 and SYH2068 Dose 3 in people with Adult Participants With Elevated Lipoprotein(a), run by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd..
Trial summary
The purpose of this study is to evaluate the efficacy and safety of SYH2068 injection in patients with elevated lipoprotein(a). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Participants With Elevated Lipoprotein(a)
- What is being tested?
- SYH2068 Dose 1, SYH2068 Dose 2 and SYH2068 Dose 3
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 30 Jul 2026to 30 Sep 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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).
Read the 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.
- Being tested
- SYH2068 Dose 1, SYH2068 Dose 2, SYH2068 Dose 3, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYH2068 Dose 1Drug
Administered by subcutaneous injection.
SYH2068 Dose 2Drug
Administered by subcutaneous injection.
SYH2068 Dose 3Drug
Administered by subcutaneous injection.
PlaceboDrug
Administered by subcutaneous injection.
| Study group | Role | What they receive |
|---|---|---|
| SYH2068 Dose 1 | Experimental | Not described Receives: Drug: SYH2068 Dose 1 |
| SYH2068 Dose 2 | Experimental | Not described Receives: Drug: SYH2068 Dose 2 |
| SYH2068 Dose 3 | Experimental | Not described Receives: Drug: SYH2068 Dose 3 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in Lp(a) from baseline to Day 60~180
Measured: Day 60~180
Secondary outcomes (7)
Percentage change in Lp(a) from baseline to Day 30~540
Measured: Day 30~540
The percentage of participants achieving Lp(a) < 125 nmol/L and <75 nmol/L.
Measured: Day 30~540
Changes of LDL-C from baseline to Day 30~540
Measured: Day 30~540
Changes of ApoB from baseline to Day 30~540
Measured: Day 30~540
Incidence of TEAEs during the treatment
Measured: During treatment
ADA incidence
Measured: During treatment
The plasma concentration of SYH2068.
Measured: During treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start30 Jul 2026 (estimated)
- Primary completion30 Mar 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adult Participants With Elevated Lipoprotein(a)Studies of the same condition, open and under way.
- More trials run by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07640217
- Sponsor's protocol ID
- SYH2068-002
- Status last verified
- Jun 2026
- First submitted
- 5 Jun 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized, Double-Blind, Parallel-group, Placebo-Controlled Trial of SYH2068 Injection in Adults With Elevated Lipoprotein(a)
- ClinicalTrials.gov ID
- NCT07640217
- Acronym / sponsor ID
- SYH2068-002
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Jul 2026 (estimated)
- Primary completion
- 30 Mar 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 10 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SYH2068 Dose 1 | Experimental | Drug: SYH2068 Dose 1 |
| SYH2068 Dose 2 | Experimental | Drug: SYH2068 Dose 2 |
| SYH2068 Dose 3 | Experimental | Drug: SYH2068 Dose 3 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SYH2068 Dose 1Administered by subcutaneous injection. | Drug | SYH2068 Dose 1 |
| SYH2068 Dose 2Administered by subcutaneous injection. | Drug | SYH2068 Dose 2 |
| SYH2068 Dose 3Administered by subcutaneous injection. | Drug | SYH2068 Dose 3 |
| PlaceboAdministered by subcutaneous injection. | Drug | Placebo |
Primary outcome
Percentage change in Lp(a) from baseline to Day 60~180
Time frame: Day 60~180
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SYH2068 Dose 1, SYH2068 Dose 2 and SYH2068 Dose 3 in people with Adult Participants With Elevated Lipoprotein(a), run by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Information Group officer (0311-69085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage change in Lp(a) from baseline to Day 60~180 (time frame: Day 60~180). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.