Hypercholesterolemia and Mixed DyslipidemiaPhase 2NCT07278830
A Phase II Study to Evaluate the Safety and Efficacy of SAL003 Combined With Atorvastatin in Hypercholesterolemia and Mixed Dyslipidemia
A Phase 2 study testing SAL003 140mg+Atorvastatin and SAL003 420mg+Atorvastatin in people with Hypercholesterolemia and Mixed Dyslipidemia, run by Shenzhen Salubris Pharmaceuticals Co., Ltd. at 1 site in China.
Trial summary
This is a Phase II, multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of SAL003, a recombinant fully human anti-PCSK9 monoclonal antibody, in combination with a stable dose of atorvastatin in patients with hypercholesterolemia and mixed dyslipidemia. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypercholesterolemia and Mixed Dyslipidemia
- What is being tested?
- SAL003 140mg+Atorvastatin and SAL003 420mg+Atorvastatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 214 participants
- Where
- 1 siteChina
- Study dates
- 2 Jun 2023to 7 Jun 2024
- 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
- Subjects aged 18 to 75 years.
- Diagnosis of hypercholesterolemia and/or mixed dyslipidemia per the 2016 Chinese guidelines.
- On a stable statin regimen as defined by the two pathways:
- Pathway 1: On other statins or irregular atorvastatin, willing to switch to/stabilize on atorvastatin.
- Pathway 2: On stable, regular atorvastatin (Lipitor) for ≥4 weeks.
- Fasting LDL-C must be above target:
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- With ASCVD history: ≥1.8 mmol/L (70 mg/dL)
- Without ASCVD history: ≥2.6 mmol/L (100 mg/dL)
- Fasting triglycerides (TG) ≤ 5.6 mmol/L (500 mg/dL) at screening.
- Provide signed informed consent.
Who cannot join
- Suffering from homozygous familial hypercholesterolemia (HoFH); Other diseases that may cause secondary increase of LDL-C: Cushing's syndrome, nephrotic syndrome, myeloma, glycogen storage disease, systemic lupus erythematosus, acute intermittent porphyria;
- Route 1: The medication compliance of atorvastatin during the induction period is less than 80% or more than 120%; Route 2: The medication compliance of atorvastatin within 28 days before screening is less than 80% or more than 120%;
- Within 3 months before screening, there is heart failure (NYHA cardiac function classification of grade III and IV), acute coronary syndrome, percutaneous coronary intervention, or other serious heart diseases [such as cardiogenic shock, grade II-III atrioventricular block, bradycardia (heart rate < 50 beats/minute), other serious arrhythmias, etc.];
- Within 3 months before screening, there is a serious cerebrovascular disease (hypertensive encephalopathy, cerebral vascular injury, stroke, transient ischemic attack, etc.), or there is a serious aortic or peripheral vascular lesion, or there are indications for surgical intervention;
- Within 3 months before screening, there is a major surgical history or plans to undergo major surgery during the study period;
- Patients with poorly controlled hypertension (SBP ≥ 160 mm Hg or DBP ≥ 100 mm Hg);
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- Diabetic patients with the following conditions known: 1) Type 1 diabetic patients; 2) Type 2 diabetic patients with poor blood sugar control (HbA1c > 8.0%);
- Patients with active viral hepatitis (including hepatitis B and hepatitis C), other severe liver diseases, or liver dysfunction (ALT or AST > 2.5 times the upper limit of normal, TBIL > 2 times the upper limit of normal);
- Glomerular filtration rate (eGFR) < 30 ml/min/1.73m2 during the screening period;
- Patients with abnormal thyroid function (thyroid stimulating hormone TSH exceeds the normal range of the center);
- CK > 3 times the upper limit of normal during the screening period;
- Positive for AIDS or syphilis tests;
- Active malignant tumors, or patients with a history of malignant tumors within 5 years before screening (excluding skin basal cell carcinoma or cervical carcinoma in situ);
- Patients known to be allergic to the test drug or any component of the test drug, or who have had a severe allergic reaction to other antibody-based drugs;
- Patients with a history of organ transplantation;
- Within 3 months before screening, blood donation or significant blood loss (> 400 mL), or those diagnosed with insufficient blood volume;
- Within 30 days before the administration of the study drug, use of any known substances that can affect lipid metabolism, tonics (such as fish oil > 1000 mg/day, drugs containing red yeast rice components or health supplements), or other cholesterol-lowering drugs other than statins;
- Within 3 months before screening, participated in other drug or device clinical trials, or within 6 months before screening received any treatment targeting the proprotein convertase subtilisin/kexin type 9 (PCSK9) target;
- Within 6 months before screening had a history of drug abuse or alcoholism (14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine);
- Female subjects during the screening period or during the trial are breastfeeding or have a positive serum pregnancy result;
- The subject or the subject's spouse or partner has a pregnancy plan or refuses to adopt an acceptable effective contraceptive method from the time of signing the informed consent form to the end of the last administration;
- The subject and his/her spouse or partner have a pregnancy plan or refuse to adopt an acceptable effective contraceptive method from the time of signing the informed consent form to the end of the last administration within 6 months;
- Patients considered not suitable for participating in the clinical trial by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site
Sun Yat-sen Memorial Hospital, Sun Yat-sen University，Guangzhou，Guangdong，510120
Guangzhou, Guangdong, 510120
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Safety and Efficacy of Recombinant Fully Human Anti-PCSK9 Monoclonal Antibody Injection (SAL003) Combined With Atorvastatin in Subjects With Hypercholesterolemia and Mixed Dyslipidemia
This is a Phase II, multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of SAL003, a recombinant fully human anti-PCSK9 monoclonal antibody, in combination with a stable dose of atorvastatin in patients with hypercholesterolemia and mixed dyslipidemia.
Read the detailed description
This is a Phase II, multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy, safety, and pharmacokinetics of SAL003, a recombinant fully human anti-PCSK9 monoclonal antibody, when used in combination with stable, background atorvastatin therapy in adult patients with hypercholesterolemia and mixed dyslipidemia.
The study is structured into four distinct periods to ensure patient eligibility, standardize background therapy, and assess both short-term and longer-term effects of the investigational product.
- Being tested
- SAL003 140mg+Atorvastatin, SAL003 420mg+Atorvastatin, Placebo 140mg+Atorvastatin, Placebo 420mg+Atorvastatin
- Keywords
- LDL-C (Low-Density Lipoprotein Cholesterol), PCSK9 Inhibitor, SAL003
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAL003 140mg+AtorvastatinDrug
Double-blind treatment period: During the stable dose of atorvastatin treatment, 140mg of SAL003 was administered once every 4 weeks for a total of 6 times. Extended treatment period: During the stable dose of atorvastatin treatment, 140mg of SAL003 was administered once every 4 weeks for a total of 2 times.
SAL003 420mg+AtorvastatinDrug
Double-blind treatment period: During the stable dose of atorvastatin treatment, 420mg of SAL003 was administered once every 8 weeks for a total of 3 times. Extended treatment period: During the stable dose of atorvastatin treatment, 140mg of SAL003 was administered once every 4 weeks for a total of 2 times.
Placebo 140mg+AtorvastatinDrug
Double-blind treatment period: During the stable dose of atorvastatin treatment, 140mg of Placebo was administered once every 4 weeks for a total of 6 times. Extended treatment period: During the stable dose of atorvastatin treatment, 140mg of SAL003 was administered once every 4 weeks for a total of 2 times.
Placebo 420mg+AtorvastatinDrug
Double-blind treatment period: During the stable dose of atorvastatin treatment, 420mg of Placebo was administered once every 8 weeks for a total of 3 times. Extended treatment period: During the stable dose of atorvastatin treatment, 140mg of SAL003 was administered once every 4 weeks for a total of 2 times.
| Study group | Role | What they receive |
|---|---|---|
| Test Group Q4W | Experimental | Not described Receives: Drug: SAL003 140mg+Atorvastatin |
| Test Group Q8W | Experimental | Not described Receives: Drug: SAL003 420mg+Atorvastatin |
| Reference Group Q4W | Placebo comparator | Not described Receives: Drug: Placebo 140mg+Atorvastatin |
| Reference Group Q8W | Placebo comparator | Not described Receives: Drug: Placebo 420mg+Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change of Low-Density Lipoprotein Cholesterol (LDL-C)
Percent change from baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24.
Measured: at Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start2 Jun 2023
- Primary completion24 May 2024
- Study completion7 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypercholesterolemia and Mixed DyslipidemiaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Salubris (Chengdu) Biotechnology Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07278830
- Sponsor's protocol ID
- SAL003A201
- Status last verified
- Nov 2025
- First submitted
- 1 Dec 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. 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 Study to Evaluate the Safety and Efficacy of Recombinant Fully Human Anti-PCSK9 Monoclonal Antibody Injection (SAL003) Combined With Atorvastatin in Subjects With Hypercholesterolemia and Mixed Dyslipidemia
- ClinicalTrials.gov ID
- NCT07278830
- Acronym / sponsor ID
- SAL003A201
- Keywords
- LDL-C (Low-Density Lipoprotein Cholesterol), PCSK9 Inhibitor, SAL003
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Shenzhen Salubris Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Salubris (Chengdu) Biotechnology Co., Ltd.
- Study start
- 2 Jun 2023 (actual)
- Primary completion
- 24 May 2024 (actual)
- Study completion
- 7 Jun 2024 (actual)
- First posted
- 12 Dec 2025 (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 Phase II, multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of SAL003, a recombinant fully human anti-PCSK9 monoclonal antibody, in combination with a stable dose of atorvastatin in patients with hypercholesterolemia and mixed dyslipidemia.
Detailed description
This is a Phase II, multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy, safety, and pharmacokinetics of SAL003, a recombinant fully human anti-PCSK9 monoclonal antibody, when used in combination with stable, background atorvastatin therapy in adult patients with hypercholesterolemia and mixed dyslipidemia.
The study is structured into four distinct periods to ensure patient eligibility, standardize background therapy, and assess both short-term and longer-term effects of the investigational product.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Test Group Q4W | Experimental | Drug: SAL003 140mg+Atorvastatin |
| Test Group Q8W | Experimental | Drug: SAL003 420mg+Atorvastatin |
| Reference Group Q4W | Placebo comparator | Drug: Placebo 140mg+Atorvastatin |
| Reference Group Q8W | Placebo comparator | Drug: Placebo 420mg+Atorvastatin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects aged 18 to 75 years.
- Diagnosis of hypercholesterolemia and/or mixed dyslipidemia per the 2016 Chinese guidelines.
- On a stable statin regimen as defined by the two pathways:
- Fasting LDL-C must be above target:
- Fasting triglycerides (TG) ≤ 5.6 mmol/L (500 mg/dL) at screening.
Key exclusion criteria (23 listed)
- Suffering from homozygous familial hypercholesterolemia (HoFH); Other diseases that may cause secondary increase of LDL-C: Cushing's syndrome, nephrotic syndrome, myeloma, glycogen storage disease, systemic lupus erythematosus, acute intermittent porphyria;
- Route 1: The medication compliance of atorvastatin during the induction period is less than 80% or more than 120%; Route 2: The medication compliance of atorvastatin within 28 days before screening is less than 80% or more than 120%;
- Within 3 months before screening, there is heart failure (NYHA cardiac function classification of grade III and IV), acute coronary syndrome, percutaneous coronary intervention, or other serious heart diseases [such as cardiogenic shock, grade II-III atrioventricular block, bradycardia (heart rate < 50 beats/minute), other serious arrhythmias, etc.];
- Within 3 months before screening, there is a serious cerebrovascular disease (hypertensive encephalopathy, cerebral vascular injury, stroke, transient ischemic attack, etc.), or there is a serious aortic or peripheral vascular lesion, or there are indications for surgical intervention;
- Within 3 months before screening, there is a major surgical history or plans to undergo 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 |
|---|---|---|
| SAL003 140mg+AtorvastatinDouble-blind treatment period: During the stable dose of atorvastatin treatment, 140mg of SAL003 was administered once every 4 weeks for a total of 6 times. Extended treatment period: During the stable dose of atorvastatin treatment, 140mg of SAL003 was administered once every 4 weeks for a total of 2 times. | Drug | Test Group Q4W |
| SAL003 420mg+AtorvastatinDouble-blind treatment period: During the stable dose of atorvastatin treatment, 420mg of SAL003 was administered once every 8 weeks for a total of 3 times. Extended treatment period: During the stable dose of atorvastatin treatment, 140mg of SAL003 was administered once every 4 weeks for a total of 2 times. | Drug | Test Group Q8W |
| Placebo 140mg+AtorvastatinDouble-blind treatment period: During the stable dose of atorvastatin treatment, 140mg of Placebo was administered once every 4 weeks for a total of 6 times. Extended treatment period: During the stable dose of atorvastatin treatment, 140mg of SAL003 was administered once every 4 weeks for a total of 2 times. | Drug | Reference Group Q4W |
| Placebo 420mg+AtorvastatinDouble-blind treatment period: During the stable dose of atorvastatin treatment, 420mg of Placebo was administered once every 8 weeks for a total of 3 times. Extended treatment period: During the stable dose of atorvastatin treatment, 140mg of SAL003 was administered once every 4 weeks for a total of 2 times. | Drug | Reference Group Q8W |
Primary outcome
Percent change of Low-Density Lipoprotein Cholesterol (LDL-C)
Time frame: at Week 24
Percent change from baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 24.
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 12 Dec 2025.
- Individual participant dataSharing planned: No
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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 SAL003 140mg+Atorvastatin and SAL003 420mg+Atorvastatin in people with Hypercholesterolemia and Mixed Dyslipidemia, run by Shenzhen Salubris Pharmaceuticals 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 10 inclusion and 23 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 12 Dec 2025. 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?
Percent change of Low-Density Lipoprotein Cholesterol (LDL-C) (time frame: at 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 12 Dec 2025.