Can a daily pill slash high lipoprotein(a) — a hidden heart risk with no approved treatment?
NCT ID NCT07729475
First seen Jul 27, 2026 · Last updated Jul 28, 2026 · Updated 1 time
Summary
This phase 2 trial tests whether an experimental oral drug, SAL0137, can safely lower high levels of lipoprotein(a) — a genetic risk factor for heart attacks and strokes that currently has no approved medication. About 120 adults with elevated Lp(a) and high cardiovascular risk will receive one of three doses of SAL0137 or a placebo for 12 weeks. The study measures how much Lp(a) levels drop and monitors for side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- an experimental oral drug called SAL0137
- What this could lead to
- If successful, this could lead to a new daily pill to lower high lipoprotein(a) — a genetic risk factor for heart attacks and strokes that currently has no approved treatment.
- What could go wrong
- This is an early-phase trial with only 120 participants, so results may not apply to everyone. The drug's long-term safety and ability to actually prevent heart events are not yet known.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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: 1. Aged ≥ 18 years on the date of signing the informed consent form, male or female; 2. Body mass index (BMI) within the range of 18.5 to 40.0 kg/m² (inclusive); 3. Participants must be at elevated risk for cardiovascular events; 4. Lp(a) ≥ 150 nmol/L (or ≥ 60 mg/dL) at screening or prior to randomization; 5. 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 6. Compliance with study drug administration during the run-in period prior to randomization must be between 80% and 120%; 7. 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; 8. 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: 1. 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; 2. Planned cardiac, cerebrovascular, or peripheral artery surgery, or coronary revascularization, or other major surgery after randomization; 3. 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); 4. Previous history of diseases that significantly affect lipid levels, such as nephrotic syndrome, severe liver disease, Cushing's syndrome, etc.; 5. History of acute kidney injury within 12 months prior to screening; 6. Uncontrolled hyperthyroidism or hypothyroidism; 7. 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); 8. 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; 9. New York Heart Association (NYHA) Class III or IV cardiac function prior to screening; 10. Lipoprotein apheresis within 3 months prior to screening, or planned during the study period; 11. Use of weight-loss medications (see Appendix 3) or undergone surgery causing weight instability within 2 months prior to screening; 12. Long-term continuous or repeated use of systemic glucocorticoids within 3 months prior to screening; 13. Known allergy to the active ingredient or any excipients of SAL0137; 14. Uncontrolled hypertension at screening or prior to randomization (office sitting systolic blood pressure ≥ 160 mmHg and/or office sitting diastolic blood pressure ≥ 100 mmHg); 15. Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m² at screening or prior to randomization (calculated using the CKD-EPI 2021 formula, see Appendix 4), or undergoing dialysis; 16. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or gamma-glutamyl transferase (GGT) \> 3 × upper limit of normal (ULN), or total bilirubin \> 2 × ULN at screening or prior to randomization; 17. Fasting triglycerides ≥ 5.6 mmol/L at screening or prior to randomization; 18. Creatine kinase (CK) \> 3 × ULN at screening or prior to randomization; 19. Thyroid-stimulating hormone (TSH) \< lower limit of normal (LLN) or \> 1.5 × ULN at screening or prior to randomization; 20. History of drug or alcohol abuse or dependence within 6 months prior to screening (average weekly alcohol intake \> 14 standard units; 1 unit = 285 mL beer, or 25 mL spirits, or 100 mL wine); 21. Positive virology test results at screening, including hepatitis B surface antigen (if positive, the investigator may decide whether to perform HBV-DNA quantification), HCV antibody, HIV antibody, and Treponema pallidum-specific antibody; 22. Participation in any drug clinical trial and use of investigational drug within 3 months prior to screening (or within 5 half-lives of the investigational drug, whichever is longer), or participation in any medical device clinical trial and use of a medical device; 23. Any other reasons that, in the investigator's opinion, may affect the evaluation of efficacy and/or safety of this study, or make the participant unsuitable for participation in this clinical trial (including but not limited to poor compliance as judged by the investigator, or remote residence precluding scheduled follow-up visits).
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
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