Non-familial Hypercholesterolemia and Mixed HyperlipidemiaPhase 3NCT07421284
A Study to Evaluate the Safety, Efficacy of SYH2053 in Chinese Participants With Non-familial Hypercholesterolemia and Mixed Hyperlipidemia on a Background of Lipid-lowering Therapy
A Phase 3 study of Non-familial Hypercholesterolemia and Mixed Hyperlipidemia, run by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to compare the effectiveness, safety of SYH2053 in participants with primary hypercholesterolemia (non-familial) or mixed dyslipidemia on a background of lipid-lowering therapy. This trial plans to enroll 900 Participants. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-familial Hypercholesterolemia and Mixed Hyperlipidemia
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 900 participants
- Where
- 1 siteChina
- Study dates
- 31 Mar 2026to 31 Jan 2028
- Phase
- Phase 3
- 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
- Age of 18 - 75 years (inclusive);
- Participants with primary hypercholesterolemia or mixed dyslipidemia who have maintained stable dose of lipid-lowering therapy (statin with other lipid-lowering therapy) ≥4 weeks;
- Fasting serum low-density lipoprotein cholesterol (LDL-C) levels failing to meet the target criteria at screening and prior to randomization (based on local laboratory results). Any one of the following conditions satisfies the criterion(according to the 2023 Chinese Guidelines for Lipid Management):
- With a history of ASCVD:
- Very high risk: 55 mg/dL (1.4 mmol/L) ≤ LDL-C < 188 mg/dL (4.9 mmol/L);
- Extremely high risk: LDL-C ≥ 70 mg/dL (1.8 mmol/L);
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- Without a history of ASCVD:
- Moderate to high risk: LDL-C ≥ 100 mg/dL (2.6 mmol/L);
- Low risk: LDL-C ≥ 130 mg/dL (3.4 mmol/L); 4.Participants are able to establish good communication with the investigator and complete the trial in accordance with the protocol.
Who cannot join
- Prior diagnosis of familial hypercholesterolemia; or a history of the following diseases: Cushing's syndrome, nephrotic syndrome, myeloma, glycogen storage disease, systemic lupus erythematosus, acute intermittent porphyria, cirrhosis, severe biliary obstruction, or other diseases known to significantly cause dyslipidemia；
- Treatment with PCSK9 monoclonal antibodies or oral PCSK9 inhibitors within the past 180 days before screening or treatment with incisiran or any other RNA-based lipid-lowering therapy within the past 2 years before screening;
- History of malignancy within 5 years (excluding treated basal cell carcinoma of the skin), or presence of a suspected malignancy currently being evaluated by the investigator;
- Systolic blood pressure (SBP) > 180 mmHg or diastolic blood pressure (DBP) > 110 mmHg during the Screening Period or prior to Randomization;
- History of heart failure with NYHA Class III-IV within 180days before screening or prior to Randomization, or LVEF < 40% within 180 days before screening;
- eGFR < 30 mL/min/1.73 m² during the Screening Period or prior to Randomization;
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- Creatine Kinase (CK) > 3 × ULN at Screening Period;
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 × ULN or Total Bilirubin (TBIL), > 1.5 × ULN at Screening Period or prior to Randomization;
- Prolonged QT/QTcF interval at Screening Period or prior to Randomization (QTcF > 450 ms for males, > 470 ms for females)
- Positive result for any one of hepatitis B surface antigen (HBsAg), Hepatitis C virus (HCV) antibody, syphilis antibody, or Human Immunodeficiency Virus (HIV) antibody;
- HbA1c > 8.0% at screening Period or prior to Randomization; or Type 1 diabetes , gestational diabetes ;
- History of drug abuse within 5 years, including the recurrent use of dependence-producing drugs or substances unrelated to medical purposes in large quantities, including addictive and habituating drugs that cause physical and psychological dependence;
- History of alcohol abuse within 1 year (defined as consuming more than 14 units of alcohol per week [1 unit = 360 mL of beer with 5% alcohol content, or 45 mL of spirits with 40% alcohol content, or 150 mL of wine with 12% alcohol content]);
- Participation in any other clinical trial involving the administration of an investigational drug within 3 months prior to Screening or within 5 half-lives of the other investigational drug (whichever is longer), or plans to participate in any other clinical trial during the study period;
- Any condition that, in the Investigator's opinion, may interfere with the conduct of the study, including but not limited to: a. presence of any disease within 6 months prior to Screening through the study period that may interfere with study results; b. any other reason that would prevent the subject from completing the study or that makes them inappropriate for inclusion;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Affiliation: Peking University Third Hospital
Beijing, Beijing Municipality
Yida Tang, PhD, 13901010211, tang_yida@163.com
About this study
Official title: A Phase Ⅲ Randomized, Parallel-group, Placebo-controlled Trial to Assess the Efficacy, Safety of the SYH2053 Subcutaneous Injection in Participants With Primary Hypercholesterolemia (Non-familial) or Mixed Dyslipidemia on a Background of Lipid-lowering Therapy
The purpose of this study is to compare the effectiveness, safety of SYH2053 in participants with primary hypercholesterolemia (non-familial) or mixed dyslipidemia on a background of lipid-lowering therapy.
This trial plans to enroll 900 Participants.
- Being tested
- SYH2053/placebo injection
- Medical subject headings
- Hyperlipoproteinemia Type II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYH2053/placebo injectionDrug
Participants receive SYH2053/placebo injection by subcutaneous administration.
| Study group | Role | What they receive |
|---|---|---|
| SYH2053 injection | Experimental | Participants in this cohort receive three doses Receives: Drug: SYH2053/placebo injection |
| SYH2053 injection placebo | Placebo comparator | Participants in this cohort receive three doses Receives: Drug: SYH2053/placebo injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in LDL-C relative to baseline
Measured: Day 330
Secondary outcomes (4)
The value of change in LDL-C relative to baseline
Measured: Day 330
Time adjusted percent change in LDL-C levels from baseline between Day 90 and Day 360 levels
Measured: Day 90-360
Incidence and severity of adverse events (AE), serious adverse events (SAE), etc. Description:
Measured: Days 1-360
Number of ADA and Nab
Measured: Day 30-360
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start31 Mar 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-familial Hypercholesterolemia and Mixed HyperlipidemiaStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07421284
- Sponsor's protocol ID
- SYH2053-004
- Status last verified
- Feb 2026
- First submitted
- 12 Feb 2026
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ⅲ Randomized, Parallel-group, Placebo-controlled Trial to Assess the Efficacy, Safety of the SYH2053 Subcutaneous Injection in Participants With Primary Hypercholesterolemia (Non-familial) or Mixed Dyslipidemia on a Background of Lipid-lowering Therapy
- ClinicalTrials.gov ID
- NCT07421284
- Acronym / sponsor ID
- SYH2053-004
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Mar 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 19 Feb 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 compare the effectiveness, safety of SYH2053 in participants with primary hypercholesterolemia (non-familial) or mixed dyslipidemia on a background of lipid-lowering therapy.
This trial plans to enroll 900 Participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SYH2053 injection | Experimental | Drug: SYH2053/placebo injectionParticipants in this cohort receive three doses |
| SYH2053 injection placebo | Placebo comparator | Drug: SYH2053/placebo injectionParticipants in this cohort receive three doses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age of 18 - 75 years (inclusive);
- Participants with primary hypercholesterolemia or mixed dyslipidemia who have maintained stable dose of lipid-lowering therapy (statin with other lipid-lowering therapy) ≥4 weeks;
- Fasting serum low-density lipoprotein cholesterol (LDL-C) levels failing to meet the target criteria at screening and prior to randomization (based on local laboratory results). Any one of the following conditions satisfies the criterion(according to the 2023 Chinese Guidelines for Lipid Management):
- Very high risk: 55 mg/dL (1.4 mmol/L) ≤ LDL-C < 188 mg/dL (4.9 mmol/L);
- Extremely high risk: LDL-C ≥ 70 mg/dL (1.8 mmol/L);
Key exclusion criteria (15 listed)
- Prior diagnosis of familial hypercholesterolemia; or a history of the following diseases: Cushing's syndrome, nephrotic syndrome, myeloma, glycogen storage disease, systemic lupus erythematosus, acute intermittent porphyria, cirrhosis, severe biliary obstruction, or other diseases known to significantly cause dyslipidemia；
- Treatment with PCSK9 monoclonal antibodies or oral PCSK9 inhibitors within the past 180 days before screening or treatment with incisiran or any other RNA-based lipid-lowering therapy within the past 2 years before screening;
- History of malignancy within 5 years (excluding treated basal cell carcinoma of the skin), or presence of a suspected malignancy currently being evaluated by the investigator;
- Systolic blood pressure (SBP) > 180 mmHg or diastolic blood pressure (DBP) > 110 mmHg during the Screening Period or prior to Randomization;
- History of heart failure with NYHA Class III-IV within 180days before screening or prior to Randomization, or LVEF < 40% within 180 days before 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 |
|---|---|---|
| SYH2053/placebo injectionParticipants receive SYH2053/placebo injection by subcutaneous administration. | Drug | SYH2053 injection, SYH2053 injection placebo |
Primary outcome
Percentage change in LDL-C relative to baseline
Time frame: Day 330
4 secondary outcomes
The value of change in LDL-C relative to baseline
Time frame: Day 330
Time adjusted percent change in LDL-C levels from baseline between Day 90 and Day 360 levels
Time frame: Day 90-360
Incidence and severity of adverse events (AE), serious adverse events (SAE), etc. Description:
Time frame: Days 1-360
Number of ADA and Nab
Time frame: Day 30-360
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 19 Feb 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Non-familial Hypercholesterolemia and Mixed Hyperlipidemia, run by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. at 1 site in China.
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 9 inclusion and 15 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 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 LDL-C relative to baseline (time frame: Day 330). 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 19 Feb 2026.