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Can a daily pill tame a hidden heart risk?

NCT ID NCT07745114

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 04, 2026 · Last updated Aug 05, 2026 · Updated 1 time

Summary

This early-stage trial tests an experimental oral drug called SAL0137 in healthy adults, some with elevated Lp(a), a genetic risk factor for heart disease. The study aims to check the drug's safety, how the body processes it, and its effect on Lp(a) levels. Participants receive either the drug or a placebo, with some taking a single dose and others taking it daily for two weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SAL0137 tablets
What this could lead to
If successful, this could lead to a daily pill that lowers Lp(a), a risk factor for heart disease, potentially reducing cardiovascular risk.
What could go wrong
This is an early-phase trial focused on safety and dosing, not effectiveness. The drug may not lower Lp(a) as hoped or could have side effects.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 144 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Sep 2026

An estimate. End dates often move.

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 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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. Have fully understood the study and voluntarily sign the written informed consent form, and are able to comply with the requirements and restrictions listed in the informed consent form; 2. Male or female participants aged 18 to 65 years (inclusive); 3. At screening, weight ≥50 kg for males and ≥45 kg for females, and body mass index (BMI) between 19.0 and 28.0 kg/m2 (inclusive; BMI = weight ÷ height2); 4. At screening, results of all examinations (including physical examination, vital signs, hematology, urinalysis, blood chemistry, coagulation tests, viral serology and 12-lead electrocardiogram) other than Lp(a) are normal or have minor abnormalities judged by the investigator to be of no clinical significance, where fibrinogen should not be below the lower limit of the normal range. 5. At screening, Lp(a) for participants in Part B and Part C should be ≥75 nmoL/L(or 300 mg/L); 6. The participants or their partners have no plans for pregnancy during the study and for 6 months after the last dose of the study drug, and are willing to use effective contraceptive measures (the use of contraceptive pills is prohibited during the study). In addition, the participants will not donate sperm or eggs (oocytes) for reproductive or assisted reproductive purposes. Exclusion Criteria: 1. Pregnant or lactating women, or women of childbearing potential with a positive pregnancy screening result, or female participants of childbearing potential who have had unprotected sexual intercourse within 14 days before the first dose; 2. Any disease (e.g., acute gastritis, gastrointestinal ulcer, Henoch-Schonlein purpura, lupus erythematosus, etc.) or medical history (e.g., history of intracranial haemorrhage, history of intraocular haemorrhage, history of haemophilia, history of von Willebrand disease, etc.) that, in the investigator's judgment, could alter or increase the haemorrhagic diathesis; 3. History of clinically significant acute drug or food allergy within 2 weeks before screening, or allergic diathesis (e.g., allergy to two or more drugs, foods, or pollens), or a history of allergic diseases (e.g., asthma, urticaria, eczematous dermatitis, etc.), or known or suspected allergy, hypersensitivity, or clinically significant reaction to the investigational product (including similar drugs or the control drug) or any of its excipients, as judged by the investigator; 4. Positive result for any of the following tests: hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, and Treponema pallidum specific antibody; 5. Use of any of the following foods, drugs, or treatments before the first dose: 1. Use of any inhibitors or inducers of metabolic enzymes and transporters within 2 weeks before the first dose; 2. Use of any prescription drugs, over-the-counter drugs, Chinese herbal medicines, and dietary supplements (including vitamins, health products, etc.) within 2 weeks before the first dose; 3. Consumption of foods or beverages containing grapefruit from 48 hours before the first dose until study withdrawal; 4. Consumption of foods or beverages containing caffeine (e.g., strong tea, coffee, cola) or rich in xanthine (e.g., chocolate, cocoa beans) from 48 hours before the first dose until study withdrawal. 6. Illicit drug use or drug abuse, alcoholism, or heavy smoking: 1. History of illicit drug use or drug abuse, or a positive urine drug screen at screening; 2. Average weekly alcohol use of more than 14 units in the 3 months prior to screening (1 unit ≈17.7 mL of ethanol, i.e., 1 unit ≈360 mL of 5% alcohol beer, or 45 mL of 40% alcohol liquor, or 150 mL of 12% alcohol wine), or a positive alcohol breath test at screening, or inability to completely abstain from any food or beverage containing alcohol during the study; 3. Average daily smoking of more than 5 cigarettes in the 3 months prior to screening, or inability to completely abstain from any tobacco products during the study; 7. Blood donation (including component donation) or blood loss ≥400 mL within 3 months before screening, blood donation (including component donation) or blood loss ≥200 mL or have received a transfusion within 1 month before screening, or plans to donate blood or blood components during the study or within 1 month after the end of the study; 8. Difficulty with blood sampling or inability to tolerate multiple venipunctures, or a clinically significant history of needle or blood phobia as judged by the investigator; 9. Have dysphagia, or have special dietary requirements and cannot adhere to the standardized diet; 10. Have received a live vaccine, live attenuated vaccine, or any vaccine with live viral components within 3 months before screening, or plan to receive such vaccines during the study or within 1 month after the end of the study; 11. Have experienced severe trauma or have received major surgery (e.g., requiring general anaesthesia) within 3 months before screening, or plan to undergo surgery (except for surgery under local anaesthesia) during the study or within 3 months after the end of the study; 12. Have participated in or are currently participating in any interventional clinical study (including investigational drugs or vaccines, as well as other clinical studies of this investigational product or other groups of this study) and received an investigational product within 3 months before screening; or have received siRNA drugs within the past 12 months; or have received antisense oligonucleotide drugs/antibody drugs within the past 6 months; 13. Presence of other clinically significant diseases or medical history that, in the investigator's judgment, may interfere with the participant's ability to complete this study (including diseases or disorders involving the respiratory, cardiovascular, digestive, urogenital, hematologic, endocrine, neurological, and psychiatric systems, as well as malignancies), or other diseases or medical history that may significantly alter drug absorption, metabolism, or clearance (e.g., history of surgery judged to potentially affect the in vivo disposition of the drug, such as gastrointestinal surgery, renal surgery, or cholecystectomy), or infectious diseases; 14. Male study participants with QTCF \> 450 ms, female study participants with QTCF \> 470 ms; 15)Poor compliance as judged by the investigator, or any other factors that make the participant unsuitable for this study.

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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 ANHUI Medical University

    Hefei, Anhui, 230088, China

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