Non-familial Hypercholesterolemia and Mixed HyperlipidemiaPhase 3NCT07421297
A Study to Evaluate the Safety, Efficacy of SYH2053 as Monotherapy in Chinese Participants With Non-familial Hypercholesterolemia or Mixed Hyperlipidemia
A Phase 3 study testing SYH2053 injection in people with Non-familial Hypercholesterolemia and Mixed Hyperlipidemia, run by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. at 2 sites in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of SYH2053 monotherapy in patients with primary hypercholesterolemia (non-familial) or mixed dyslipidemia . This trial plans to enroll 760 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
- What is being tested?
- SYH2053 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 760 participants
- Where
- 2 sitesChina
- Study dates
- 28 Feb 2026to 31 Jan 2028
- Phase
- Phase 3
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 ≥18 years (inclusive);
- 、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):① Low risk: LDL-C ≥130 mg/dL（3.4 mmol/L）and LDL-C<188 mg/dL（4.9 mmol/L）; ②Moderate risk: LDL-C ≥ 100 mg/dL (2.6 mmol/L) and LDL-C<188 mg/dL（4.9 mmol/L）; 3、At screening (based on local laboratory results), Fasting serum Triglyceride (TG)<500 mg/dL（5.6 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；
- A documented history of established atherosclerotic cardiovascular disease (ASCVD), defined as a history of: acute coronary syndrome (myocardial infarction or unstable angina), chronic coronary syndrome, or prior coronary revascularization (e.g., PCI or CABG); ischemic stroke or transient ischemic attack (TIA); or significant peripheral artery disease (PAD). PAD includes conditions such as chronic limb-threatening ischemia, acute limb ischemia, or atherosclerotic disease in other major arteries (e.g., carotid, vertebral, subclavian, renal, or mesenteric arteries)；
- Treatment with short-acting lipid-lowering therapies (e.g., statins, fibrates, bempedoic acid, ezetimibe, bile acid sequestrants, niacin, omega-3 fatty acids) or any preparation of unknown composition with lipid-lowering intent (including over-the-counter, traditional, or herbal medicines) within 90 days prior to screening; or treatment with PCSK9 monoclonal antibodies or oral PCSK9 inhibitors within the past 180 days before screening or treatment with inclisiran or any other RNA-based lipid-lowering therapy (e.g., siRNA, antisense oligonucleotide) 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;
- At screening, Systolic blood pressure (SBP) > 160 mmHg or diastolic blood pressure (DBP) > 100 mmHg（either in untreated patients or in those on stable medical therapy） ;
- History of heart failure with NYHA Class III-IV within 180days before screening or prior to Randomization;
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- At screening, eGFR < 30 mL/min/1.73 m²（as calculated by the CKD-EPI equation）;
- At screening, Creatine Kinase (CK) > 3 × ULN ;
- At screening, Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 × ULN or Total Bilirubin (TBIL), > 1.5 × ULN （unless attributable to Gilbert's syndrome）;
- At screening, 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;
- At screening, 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
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Not yet recruiting
Affiliation: Peking University Third Hospital
Beijing, Beijing Municipality
Yida Tang, PhD, 13901010211, tang_yida@163.com
- Recruiting
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 as Monotherapy in Participants With Primary Hypercholesterolemia (Non-familial) or Mixed Dyslipidemia
The purpose of this study is to evaluate the efficacy and safety of SYH2053 monotherapy in patients with primary hypercholesterolemia (non-familial) or mixed dyslipidemia .
This trial plans to enroll 760 Participants.
- Being tested
- SYH2053 injection, SYH2053 injection placebo
- 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 injectionDrug
Participants receive SYH2053 injection by subcutaneous administration.
SYH2053 injection placeboOther
Participants receive SYH2053 injection placebo by subcutaneous administration.
| Study group | Role | What they receive |
|---|---|---|
| SYH2053 injection | Experimental | Administer the medication in accordance with the requirements of the clinical trial protocol Receives: Drug: SYH2053 injection |
| SYH2053 injection placebo | Placebo comparator | Administer the medication in accordance with the requirements of the clinical trial protocol Receives: Other: SYH2053 injection placebo |
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 start28 Feb 2026
- 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
- 760 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
- NCT07421297
- Sponsor's protocol ID
- SYH2053-005
- Status last verified
- Feb 2026
- First submitted
- 12 Feb 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No