A Study of SAL003 in Participants With Hypercholesterolemia and Mixed Dyslipidemia (NCT07295418) | Clinical Trial Compass
CompletedPhase 3
A Study of SAL003 in Participants With Hypercholesterolemia and Mixed Dyslipidemia
China618 participantsStarted 2023-10-23
Plain-language summary
This is a Phase 3 study to evaluate the efficacy and safety of SAL003, a fully human monoclonal antibody against PCSK9, as monotherapy in Chinese participants with hypercholesterolemia and mixed dyslipidemia. Participants who are not on lipid-lowering therapy or have washed out from previous therapy will be randomized in a 2:1 ratio to receive either SAL003 140 mg or matching placebo, administered subcutaneously every 4 weeks for 12 weeks. Following the double-blind period, all participants will enter an open-label extension period and receive SAL003 140 mg Q4W for an additional 40 weeks. The primary objective is to demonstrate the superiority of SAL003 over placebo in reducing Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female, aged 18 to 75 years (inclusive).
* Fasting LDL-C ≥2.6 mmol/L and \<4.9 mmol/L at screening/randomization.
* Meets criteria based on the 2023 Chinese Lipid Management Guidelines (e.g., specific LDL-C levels with certain risk factors, or presence of diabetes).
* Fasting triglycerides (TG) ≤5.6 mmol/L at screening/randomization.
* Provides written informed consent.
Exclusion Criteria:
* Diagnosis of familial hypercholesterolemia (HoFH or HeFH).
* History of atherosclerotic cardiovascular disease (ASCVD).
* Uncontrolled hypertension (SBP ≥160 mmHg or DBP ≥100 mmHg).
* Type 1 diabetes or poorly controlled Type 2 diabetes (HbA1c \>8.0%).
* Significant hepatic or renal impairment.
* Active liver disease or positive for HIV or Syphilis.
* History of malignancy within 5 years prior to screening.
* Use of any lipid-lowering drugs (statins, ezetimibe, etc.) or traditional Chinese medicines known to affect lipid metabolism within 3 months prior to screening.
* Prior treatment with any PCSK9 inhibitor.
* Known hypersensitivity to any component of the investigational product or history of severe allergy to antibody therapies.
* Any other condition deemed by the investigator to be unsuitable for participation.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percent change of Low-Density Lipoprotein Cholesterol (LDL-C).