A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of Oral SAL0137 in Adults With Ele… (NCT07729475) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of Oral SAL0137 in Adults With Elevated Lp(a) and Increased Risk of Cardiovascular Events
China120 participantsStarted 2026-07-27
Plain-language summary
This is a randomized, double-blind, placebo-controlled Phase II trial evaluating the efficacy and safety of oral SAL0137 in adults with elevated Lp(a) and high cardiovascular risk. Participants will be randomized 1:1:1:1 to receive low-dose SAL0137, medium-dose SAL0137, high-dose SAL0137, or placebo for a treatment period of 12 weeks. The study assesses changes in Lp(a) levels and safety parameters.
Who can participate
Age range
18 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
. Aged ≥ 18 years on the date of signing the informed consent form, male or female;
. Body mass index (BMI) within the range of 18.5 to 40.0 kg/m² (inclusive);
. Participants must be at elevated risk for cardiovascular events;
. Lp(a) ≥ 150 nmol/L (or ≥ 60 mg/dL) at screening or prior to randomization;
. Participants receiving the following medications at screening must have been on a stable regimen for the specified duration prior to screening and prior to randomization, and are expected to remain on a stable regimen throughout the study
. Compliance with study drug administration during the run-in period prior to randomization must be between 80% and 120%;
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 from Baseline in Lipoprotein (a) Lp(a)
. Participants (including their partners) must be willing to voluntarily adopt highly effective contraceptive measures from the time of signing the informed consent form until 3 months after the last dose of study drug (see Appendix 2); female participants of childbearing potential must have a negative pregnancy test (serum) and must not be breastfeeding;
. Fully understand the objectives and requirements of this study, voluntarily participate in the clinical trial and sign the written informed consent form, and be willing and able to comply with the visit, treatment, and examination procedures specified in the protocol.
Exclusion criteria
. Experienced any of the following within 3 months prior to screening or prior to randomization: myocardial infarction or unstable angina, stroke or transient ischemic attack, acute limb ischemia, hemorrhagic stroke or other major bleeding history, major cardiac or non-cardiac surgery, coronary, carotid, or peripheral artery revascularization; or other events that, in the investigator's opinion, indicate clinical instability;
. Planned cardiac, cerebrovascular, or peripheral artery surgery, or coronary revascularization, or other major surgery after randomization;
. Active malignancy, or history of malignancy within 5 years prior to screening (except for basal cell carcinoma of the skin or carcinoma in situ of the cervix that have been radically resected);
. Previous history of diseases that significantly affect lipid levels, such as nephrotic syndrome, severe liver disease, Cushing's syndrome, etc.;
. History of acute kidney injury within 12 months prior to screening;
. Uncontrolled hyperthyroidism or hypothyroidism;
. Uncontrolled type 1 or type 2 diabetes mellitus within 6 months prior to screening (including diabetic ketoacidosis or hyperglycemic hyperosmolar state, or HbA1c \> 8.5% at screening);
. Active infection requiring systemic anti-infective therapy (oral or intravenous) prior to randomization, and the infection has not clinically resolved or still requires continued anti-infective treatment prior to randomization;