Mixed HyperlipidemiaPhase 2NCT07695597
A Study of SYH2070 Injection in Participants With Mixed Hyperlipidemia
A Phase 2 study testing SYH2070 in people with Mixed Hyperlipidemia, run by CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. at 1 site in China.
Trial summary
This is a randomized, double-blind, placebo-parallel, multicenter phase II clinical trial to evaluate the efficacy and safety of SYH2070 injection in participants with mixed hyperlipidemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mixed Hyperlipidemia
- What is being tested?
- SYH2070
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2026to 10 Sep 2027
- 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
- Age ≥ 18 years old, no gender limitation;
- 1.7 mmol/L (150 mg/dL) ≤ fasting TG ≤ 5.6 mmol/L (499 mg/dL) at screening;
- fasting LDL-C ≥ 2.6 mmol/L (100 mg/dL) at screening;
- Participants must have been continuously taking stable medium-intensity or higher statin drugs for at least 4 weeks, accompanied or not by cholesterol absorption inhibitors or fibrates, and maintain the same drug, dosage, frequency and brand throughout the trial period;
- Weight index range: 18.5 kg/m2 ≤ BMI ≤ 40.0 kg/m2 at screening;
- Understand the trial procedures and methods, voluntarily participate in this trial and sign the ICF in person;
- Male participants with reproductive capacity and their partners who are reproductive-aged women must agree to use highly effective contraceptive measures during the trial period and 24 weeks after the last administration of the trial drug; serum pregnancy tests before medication, serum or urine pregnancy tests during the trial period must be negative, and not be in the lactation period; participants are not allowed to donate sperm or eggs during the trial period and 24 weeks after the last administration of the trial drug.
Who cannot join
- Genetic diagnosis or clinical diagnosis indicates homozygous familial hypercholesterolemia;
- During the screening or before randomization, there is NYHA-defined heart function grade Ⅲ-Ⅳ or known left ventricular ejection fraction < 30%;
- Within 3 months before the screening, there has been a new major cardiovascular adverse event, including acute coronary syndrome (such as myocardial infarction, unstable angina pectoris), cerebrovascular disease history (such as acute stroke or transient ischemic attack), or acute pulmonary embolism;
- Within 3 months before the screening, there are clinically significant arrhythmias, such as recurrent and symptomatic ventricular tachycardia, atrial fibrillation with rapid ventricular rate, atrial flutter with rapid ventricular rate, third-degree atrioventricular block, sinus arrest, etc.), drug or ablation-induced arrhythmias that cannot be controlled;
- Within 1 month before the screening, there is a history of percutaneous coronary intervention or peripheral artery revascularization surgery;
- At screening, there is poorly controlled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg);
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- Previously diseases that significantly affect lipid levels, such as nephrotic syndrome, severe liver diseases, Cushing's syndrome, etc.;
- Previously diagnosed with type 1 diabetes, or type 2 diabetes HbA1c > 8.5% at screening ;
- Within 1 year before the screening, there is a history of acute or chronic pancreatitis;
- Within 5 years before the screening, there is a history of malignant tumor (excluding well-treated basal cell skin cancer and cervical carcinoma in situ);
- Within 3 months before the screening, there is a history of major surgery (including coronary artery bypass grafting surgery) or planned major surgery during the trial;
- Plan to undergo percutaneous coronary intervention, coronary artery bypass grafting, carotid or peripheral artery revascularization, pacemaker implantation, cardiac resynchronization therapy, implantation of implantable cardioverter-defibrillator, etc. during the trial;
- At the time of screening or before randomization, there is an active infectious disease that the investigator deems not suitable for participation in the trial;
- Previously had a history of drug abuse, alcohol abuse, or drug addiction;
- Known to be allergic to the test drugs or have a severe allergic reaction to other small nucleic acid drugs;
- Within 6 months before the screening has used other ANGPTL3 inhibitor lipid-lowering drugs;
- Within 3 months before the screening has used PCSK9 monoclonal antibody lipid-lowering drugs;
- Within 1 year before the screening has used other siRNA lipid-lowering drugs;
- Within 2 months before the screening has received or plans to receive plasma exchange treatment;
- Within 3 months before the screening has used drugs with weight loss effects or undergone surgeries that cause unstable weight;
- Within 3 months before the screening has long-term continuous or repeated use of cyclosporine, systemic corticosteroids (excluding local use, such as intra-articular, nasal, inhalation, topical use, etc.; long-term continuous refers to ≥ 7 days; repeated refers to cumulative use ≥ 3 times);
- Within 3 months before the screening has participated in any clinical trial (excluding those who failed the screening), or is within 5 half-lives of the trial drug at the time of screening, with the longer time being the criterion;
- Any of the indicators meet the following criteria:
- 1) Alanine aminotransferase or aspartate aminotransferase or γ-glutamyl transferase exceeds 2.0 times the upper limit of normal (ULN), or total bilirubin exceeds 1.5 times of the ULN; 2) QTcF interval: for males, > 450 ms; for females, > 470 ms; 3) HBsAg positive and HBV-DNA positive; or HCV antibody positive and HCV RNA positive; or positive for HIV antibody or anti- Treponema pallidum antibody; 4) Creatine kinase exceeds 3 times of the ULN; 5) Thyroid stimulating hormone is lower than the lower limit of normal or exceeds 1.5 times of the ULN (except for those who have been using thyroid hormone replacement therapy for 12 weeks or more before LDL-C testing in the screening period); 6) eGFR < 30 mL/min/1.73m2 (calculated using the MDRD formula); 24. General criteria:
- Researchers evaluate those whose lifestyle has undergone significant changes within the previous 4 weeks, or those who cannot maintain it during the trial;
- Researchers determine that they are not suitable for subcutaneous injection;
- Pregnant or lactating women;
- Researchers judge that the participants have poor compliance or any factors that are not suitable for participating in this trial, including but not limited to participating in the trial would expose the participants to unacceptable risks or may interfere with the trial results.
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, 1 recruiting
- Recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang
Wang Jianan, PhD, 0571-87315001, wang_jian_an@vip.tom.com
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of SYH2070 Injection in Participants With Mixed Hyperlipidemia
This is a randomized, double-blind, placebo-parallel, multicenter phase II clinical trial to evaluate the efficacy and safety of SYH2070 injection in participants with mixed hyperlipidemia.
- Conditions
- Mixed Hyperlipidemia
- Being tested
- SYH2070, 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.
SYH2070Drug
SYH2070 injection, 150 mg, 300 mg, 400 mg, SC, administration duration: 24 weeks
PlaceboDrug
Placebo, SC, administration duration: 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| SYH2070, 150 mg | Experimental | Not described Receives: Drug: SYH2070 |
| SYH2070, 150 mg placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| SYH2070, 300 mg | Experimental | Not described Receives: Drug: SYH2070 |
| SYH2070, 300 mg placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| SYH2070, 400 mg | Experimental | Not described Receives: Drug: SYH2070 |
| SYH2070, 400 mg 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.
The percentage change in serum TG levels from baseline at week 24
Measured: Baseline through Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start15 Jul 2026
- Primary completion30 Apr 2027 (estimated)
- Study completion10 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07695597
- Sponsor's protocol ID
- SYH2070-004
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2026
- Last updated
- 22 Jul 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 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of SYH2070 Injection in Participants With Mixed Hyperlipidemia
- ClinicalTrials.gov ID
- NCT07695597
- Acronym / sponsor ID
- SYH2070-004
- Conditions
- Mixed Hyperlipidemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Jul 2026 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 10 Sep 2027 (estimated)
- First posted
- 10 Jul 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.
This is a randomized, double-blind, placebo-parallel, multicenter phase II clinical trial to evaluate the efficacy and safety of SYH2070 injection in participants with mixed hyperlipidemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| SYH2070, 150 mg | Experimental | Drug: SYH2070 |
| SYH2070, 150 mg placebo | Placebo comparator | Drug: Placebo |
| SYH2070, 300 mg | Experimental | Drug: SYH2070 |
| SYH2070, 300 mg placebo | Placebo comparator | Drug: Placebo |
| SYH2070, 400 mg | Experimental | Drug: SYH2070 |
| SYH2070, 400 mg 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 (7 listed)
- Age ≥ 18 years old, no gender limitation;
- 1.7 mmol/L (150 mg/dL) ≤ fasting TG ≤ 5.6 mmol/L (499 mg/dL) at screening;
- fasting LDL-C ≥ 2.6 mmol/L (100 mg/dL) at screening;
- Participants must have been continuously taking stable medium-intensity or higher statin drugs for at least 4 weeks, accompanied or not by cholesterol absorption inhibitors or fibrates, and maintain the same drug, dosage, frequency and brand throughout the trial period;
- Weight index range: 18.5 kg/m2 ≤ BMI ≤ 40.0 kg/m2 at screening;
Key exclusion criteria (28 listed)
- Genetic diagnosis or clinical diagnosis indicates homozygous familial hypercholesterolemia;
- During the screening or before randomization, there is NYHA-defined heart function grade Ⅲ-Ⅳ or known left ventricular ejection fraction < 30%;
- Within 3 months before the screening, there has been a new major cardiovascular adverse event, including acute coronary syndrome (such as myocardial infarction, unstable angina pectoris), cerebrovascular disease history (such as acute stroke or transient ischemic attack), or acute pulmonary embolism;
- Within 3 months before the screening, there are clinically significant arrhythmias, such as recurrent and symptomatic ventricular tachycardia, atrial fibrillation with rapid ventricular rate, atrial flutter with rapid ventricular rate, third-degree atrioventricular block, sinus arrest, etc.), drug or ablation-induced arrhythmias that cannot be controlled;
- Within 1 month before the screening, there is a history of percutaneous coronary intervention or peripheral artery revascularization surgery;
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 |
|---|---|---|
| SYH2070SYH2070 injection, 150 mg, 300 mg, 400 mg, SC, administration duration: 24 weeks | Drug | SYH2070, 150 mg, SYH2070, 300 mg, SYH2070, 400 mg |
| PlaceboPlacebo, SC, administration duration: 24 weeks | Drug | SYH2070, 150 mg placebo, SYH2070, 300 mg placebo, SYH2070, 400 mg placebo |
Primary outcome
The percentage change in serum TG levels from baseline at week 24
Time frame: Baseline through Week 24
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 22 Jul 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 2 study testing SYH2070 in people with 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 7 inclusion and 28 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: looking for participants now, as of the sponsor's last update on 22 Jul 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?
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?
The percentage change in serum TG levels from baseline at week 24 (time frame: Baseline through Week 24). 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 22 Jul 2026.