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New shot could help lower stubborn high cholesterol
NCT ID NCT07253584
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This Phase 3 trial tested an injectable drug called SAL003 in 720 adults with high cholesterol or mixed dyslipidemia. Participants were already on statins but still had high LDL cholesterol. The study compared SAL003 to a placebo to see if it safely lowers cholesterol further. The main goal was the percent change in LDL cholesterol after 24 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SAL003 (an anti-PCSK9 monoclonal antibody injection)
- What this could lead to
- If successful, SAL003 could offer a new option to lower stubborn high cholesterol when statins alone aren't enough, potentially reducing heart disease risk.
- What could go wrong
- This is a completed Phase 3 trial, but results are not yet public. The drug may not show enough benefit over placebo, or side effects could limit its use. It's also an add-on to statins, not a standalone treatment.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
720 people
The number who actually took part.
- Started
-
Dec 2023
- Finished
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Jun 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Subjects aged 18 to 75 years. * On a stable, moderate- to high-intensity statin regimen (with or without ezetimibe) for at least 4 weeks prior to screening. * Fasting LDL-C above target levels per 2023 Chinese guidelines: With ASCVD history: ≥1.4 mmol/L (Extreme Risk) or ≥1.8 mmol/L (Very High Risk). Without ASCVD history: ≥2.6 mmol/L (Moderate/High Risk) or ≥3.4 mmol/L (Low Risk). Fasting triglycerides (TG) ≤ 5.6 mmol/L at screening/randomization. * Provide signed informed consent. Exclusion Criteria: * Homozygous Familial Hypercholesterolemia (HoFH). * Uncontrolled hypertension (SBP ≥160 mmHg or DBP ≥100 mmHg). * Significant cardiovascular event (e.g., MI, unstable angina, stroke, PCI, CABG) within 3 months prior to screening. * Heart failure (NYHA Class III or IV) or LVEF \<40% within 3 months. * Severe renal impairment (eGFR \<30 mL/min/1.73m²). * Active liver disease or significant hepatic impairment (ALT/AST \>2.5x ULN or TBiL \>2x ULN). * Uncontrolled diabetes (HbA1c \>8.0%) or type 1 diabetes. * Use of other lipid-lowering therapies (e.g., fibrates, niacin) within 3 months or any PCSK9 inhibitor within 6 months prior to screening. * Known hypersensitivity to any component of the investigational product or other antibody therapies.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
The First Affiliated Hospital of Xi 'an Jiaotong University
Xi’an, Shanxi, China
More trials for these conditions
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