Hypercholesterolemia and Mixed HyperlipidemiaPhase 2NCT07421232
A Study to Evaluate the Safety, Efficacy of SYH2053 in Chinese Participants With Non-familial Hypercholesterolemia and Mixed Hyperlipidemia
A Phase 2 study testing Inclisiran (Leqvio®) 300mg in people with 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 or mixed dyslipidemia. A total of 156 Participants were actually enrolled Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypercholesterolemia and Mixed Hyperlipidemia
- What is being tested?
- Inclisiran (Leqvio®) 300mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- 1 siteChina
- Study dates
- 3 Dec 2024to 12 Feb 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 75 years
- 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 a low-fat diet for at least 4 weeks prior to screening. Additionally, meet one of the following criteria:
- A stable dose of lipid-lowering therapy (statin or statin intolerance with other lipid-lowering therapy) ≥4 weeks, or no use of lipid-lowering therapy for ≥4 weeks;
- According to local laboratory results, low-density lipoprotein cholesterol (LDL-C) level ≥100 mg/dL(2.6 mmol/L) and fasting triglycerides ≤400 mg/dL (4.5 mmol/L);
- Participants must understand of the study protocol, including the nature of the intervention and potential adverse events, and must provide voluntary, written informed consent before enrollment;
- Participants are able to establish good communication with the investigator and complete the trial in accordance with the protocol.
Who cannot join
- Participants with severe allergic diseases or an allergic constitution (allergies to three or more drugs or foods) or allergic to oligonucleotide drugs；
- History of treatment with PCSK9-targeted antibody therapies or PCSK9-targeted oligonucleotide therapies;
- 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 (repeat measurement allowed once);
- History of severe cardiovascular or cerebrovascular disease (e.g., hypertensive encephalopathy, acute stroke, transient ischemic attack, acute myocardial infarction, severe arrhythmia, etc.) within 6 months prior to Screening or prior to Randomization; or presence of severe aortic or peripheral vascular disease; or presence of conditions requiring surgical intervention; history of major surgery within 6 months prior to Screening or prior to Randomization; or plans for major surgery during the study period;
- History of heart failure with NYHA Class III-IV, or LVEF < 40% at Screening Period;
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- eGFR < 30 mL/min/1.73 m² at Screening Period;
- Presence of severe thyroid disease (except for subjects on a stable dose of thyroid hormone replacement therapy or anti-thyroid medication for at least 6 months prior to Screening or Randomization);
- Thyroid Stimulating Hormone (TSH) > 1.5 × ULN at Screening Period (a single repeat measurement is permitted within 1 week);
- Creatine Kinase(CK) > 3 × ULN at Screening Period (a single repeat measurement is permitted within 1 week);
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 × ULN at Screening Period (a single repeat measurement is permitted within 1 week); or any one of Total Bilirubin (TBIL), gamma-glutamyl transferase (GGT), or alkaline phosphatase (ALP) > 1.5 × ULN (a single repeat measurement is permitted within 1 week);
- 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 > 8.5% at screening Period; or unstable anti-diabetic treatment within 3 months prior to Screening for patients with Type 2 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]);
- Body weight change (gain or loss) ≥ 10% within 3 months prior to Screening;
- 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;
- Pregnant or lactating women; or women of childbearing potential and male participants who plan to father a child (including sperm or egg donation) during the study period and/or who refuse to use effective contraceptive methods.
Trial locations and contacts
1 site in 1 country.
China1 site
Affiliation: Peking University Third Hospital
Beijing, Beijing Municipality
About this study
Official title: A Phase Ⅱ Randomized, Parallel-group, Placebo-controlled, Active-controlled Trial to Assess the Efficacy, Safety of the SYH2053 Subcutaneous Injection in Participants With Primary Hypercholesterolemia or Mixed Dyslipidemia
The purpose of this study is to compare the effectiveness, safety of SYH2053 in Participants with primary hypercholesterolemia or mixed dyslipidemia.
A total of 156 Participants were actually enrolled
- Being tested
- SYH2053/placebo injection, Inclisiran (Leqvio®) 300mg
- Medical subject headings
- Hypercholesterolemia, 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.
Inclisiran (Leqvio®) 300mgDrug
Participants receive Leqvio® injection by subcutaneous administration.
| Study group | Role | What they receive |
|---|---|---|
| Low-dose SYH2053 injection | Experimental | Participants in this cohort receive two doses Receives: Drug: SYH2053/placebo injection |
| Medium-dose SYH2053 injection | Experimental | Participants in this cohort receive two doses Receives: Drug: SYH2053/placebo injection |
| High-dose SYH2053 injection | Experimental | Participants in this cohort receive two doses Receives: Drug: SYH2053/placebo injection |
| SYH2053 injection placebo | Placebo comparator | Participants in this cohort receive two doses Receives: Drug: SYH2053/placebo injection |
| Inclisiran (Leqvio®) 300mg | Active comparator | Participants in this cohort receive two doses Receives: Drug: Inclisiran (Leqvio®) 300mg |
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 180
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 start3 Dec 2024
- Primary completion30 Aug 2025
- Study completion12 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypercholesterolemia and Mixed HyperlipidemiaStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07421232
- Sponsor's protocol ID
- SYH2053-002
- 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 Ⅱ Randomized, Parallel-group, Placebo-controlled, Active-controlled Trial to Assess the Efficacy, Safety of the SYH2053 Subcutaneous Injection in Participants With Primary Hypercholesterolemia or Mixed Dyslipidemia
- ClinicalTrials.gov ID
- NCT07421232
- Acronym / sponsor ID
- SYH2053-002
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Dec 2024 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 12 Feb 2026 (actual)
- 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 or mixed dyslipidemia.
A total of 156 Participants were actually enrolled
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Low-dose SYH2053 injection | Experimental | Drug: SYH2053/placebo injectionParticipants in this cohort receive two doses |
| Medium-dose SYH2053 injection | Experimental | Drug: SYH2053/placebo injectionParticipants in this cohort receive two doses |
| High-dose SYH2053 injection | Experimental | Drug: SYH2053/placebo injectionParticipants in this cohort receive two doses |
| SYH2053 injection placebo | Placebo comparator | Drug: SYH2053/placebo injectionParticipants in this cohort receive two doses |
| Inclisiran (Leqvio®) 300mg | Active comparator | Drug: Inclisiran (Leqvio®) 300mgParticipants in this cohort receive two doses |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age of 18 - 75 years (inclusive);
- Participants with primary hypercholesterolemia or mixed dyslipidemia who have maintained a low-fat diet for at least 4 weeks prior to screening. Additionally, meet one of the following criteria:
- A stable dose of lipid-lowering therapy (statin or statin intolerance with other lipid-lowering therapy) ≥4 weeks, or no use of lipid-lowering therapy for ≥4 weeks;
- According to local laboratory results, low-density lipoprotein cholesterol (LDL-C) level ≥100 mg/dL(2.6 mmol/L) and fasting triglycerides ≤400 mg/dL (4.5 mmol/L);
- Participants must understand of the study protocol, including the nature of the intervention and potential adverse events, and must provide voluntary, written informed consent before enrollment;
Key exclusion criteria (20 listed)
- Participants with severe allergic diseases or an allergic constitution (allergies to three or more drugs or foods) or allergic to oligonucleotide drugs；
- History of treatment with PCSK9-targeted antibody therapies or PCSK9-targeted oligonucleotide therapies;
- 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 (repeat measurement allowed once);
- History of severe cardiovascular or cerebrovascular disease (e.g., hypertensive encephalopathy, acute stroke, transient ischemic attack, acute myocardial infarction, severe arrhythmia, etc.) within 6 months prior to Screening or prior to Randomization; or presence of severe aortic or peripheral vascular disease; or presence of conditions requiring surgical intervention; history of major surgery within 6 months prior to Screening or prior to Randomization; or plans for major surgery during the study period;
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 | High-dose SYH2053 injection, Low-dose SYH2053 injection, Medium-dose SYH2053 injection, SYH2053 injection placebo |
| Inclisiran (Leqvio®) 300mgParticipants receive Leqvio® injection by subcutaneous administration. | Drug | Inclisiran (Leqvio®) 300mg |
Primary outcome
Percentage change in LDL-C relative to baseline
Time frame: Day 180
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Inclisiran (Leqvio®) 300mg in people with 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 6 inclusion and 20 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: finished, 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 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 19 Feb 2026.