Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New shot aims to slash hidden heart risk in 203 patients

NCT ID NCT07185776

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests an experimental drug called HRS-5632 in 203 adults with high levels of lipoprotein(a), a fatty substance that raises the risk of heart attacks and strokes. Participants receive either the drug or a placebo to see if the drug safely lowers this substance. The goal is to find a new way to control heart disease risk.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

203 people

The number who actually took part.

Started

Oct 2025

Expected to finish

Oct 2027

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 years and older

Sex

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Understanding the specific procedures of the trial, voluntarily participating in this trial, and providing written informed consent; 2. Being at least 18 years of age on the day of signing the informed consent form; 3. Body Mass Index (BMI) within the range of 18.5 to 40 kg/m² (inclusive of boundary values); 4. Participants must be at high risk of cardiovascular events, defined as individuals diagnosed with Atherosclerotic Cardiovascular Disease (ASCVD) and those at moderate risk or high risk for ASCVD; 5. Based on clinical practice, participants receiving the following medications must be receiving a stable regimen prior to screening or randomization and expected to remain on a stable regimen at the end of the treatment follow-up period: 1. Lipid-lowering drugs (statins, cholesterol absorption inhibitors, prescription-dose niacin, fibrates, fish oil or other omega-3 fatty acid-containing products, including over-the-counter \[OTC\] preparations) must be receiving a stable regimen for ≥ 8 weeks prior to randomization; PCSK9 monoclonal antibodies must be receiving a stable regimen for ≥ 12 weeks prior to screening; 2. Testosterone, estrogen, anti-estrogen/anti-androgen, progestin, selective estrogen receptor modulator, or growth hormone must be receiving a stable regimen for ≥ 4 weeks prior to screening; 6. Participants (including their partners) are willing to voluntarily use highly effective contraceptive measures from the time of signing the informed consent form until 1 year after the last administration of the study drug; female participants must have a negative blood pregnancy test and must not be breastfeeding; 7. Willing and able to comply with all the provisions of the protocol, including demonstrating the ability to adhere to study procedures prior to random assignment. Exclusion Criteria: 1. Any of the following events occurring within 3 months prior to screening or between screening and randomization, or other events considered by the investigator to indicate clinical instability: major cardiac or non-cardiac surgery; coronary, carotid, or peripheral arterial revascularization; stroke or transient ischemic attack, myocardial infarction or unstable angina, acute limb ischemia, and uncontrolled arrhythmias requiring treatment; 2. Cardiac, cerebrovascular, or peripheral arterial surgery or coronary revascularization planned or anticipated during the trial after randomization; 3. A history of hemorrhagic stroke or other major bleeding (e.g., hemophilia, von Willebrand disease, coagulation factor deficiency), or a hemorrhagic stroke or other major bleeding event (fatal; major organ bleeding; resulting in a rapid, short-term decrease in hemoglobin or blood transfusion) occurring between the screening visit and the randomization visit; 4. Patients with an indication for anticoagulation at screening but not receiving anticoagulation therapy, such as patients with atrial fibrillation or flutter or those undergoing aortic valve replacement; 5. History of any organ system malignancy within 5 years prior to screening (excluding cured basal cell or squamous cell skin cancer, non-invasive stage 0 cervical cancer, non-invasive stage 0 prostate cancer, or ductal carcinoma in situ of the breast), or a history of any organ system malignancy diagnosed between the screening visit and the randomization visit, regardless of whether there is evidence of local recurrence or metastasis; 6. A history of a disease that significantly affects lipid levels, such as nephrotic syndrome, severe liver disease, or Cushing's syndrome; 7. Uncontrolled type 1 or type 2 diabetes (including diabetic ketoacidosis or hyperglycemic hyperosmolar state) within 6 months prior to screening, or HbA1c \> 8.0% at screening (secondary confirmation is permitted); 8. History of acute kidney injury within 12 months prior to screening; 9. Uncontrolled hyperthyroidism or hypothyroidism at screening or before randomization; 10. Active infection requiring systemic antiviral or antibacterial medication before randomization; 11. New York Heart Association (NYHA) class III-IV heart function or a most recently measured left ventricular ejection fraction (LVEF) \<30% at screening or before randomization; 12. At screening or before randomization, patients, as determined by the investigator, have a major medical condition that is currently unstable and not adequately controlled, such as hematologic disease, renal disease, metabolic or endocrine dysfunction, gastrointestinal disease, chronic disease or infection, unstable mental health disorder, or are recovering from major surgery; 13. Long-term continuous or repeated use of systemic corticosteroids within 3 months prior to screening (excluding local use, such as intra-articular, nasal, inhaled, topical, etc.; long-term continuous means ≥ 7 days; repeated means cumulative use ≥ 3 times); 14. Lipoprotein apheresis within 3 months prior to screening, or plans to undergo such treatment during the study; 15. Patients who are allergic to the active ingredient or any excipients of HRS-5632; 16. Uncontrolled hypertension (sitting systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg) before randomization; 17. eGFR \< 30 ml/min/1.73 m² (calculated using the CKD-EPI 2009 formula) at screening or before randomization, or current dialysis; 18. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or gamma-glutamyltransferase (GGT) more than 3 times the upper limit of normal (ULN), or total bilirubin more than 1.5 times the ULN at screening or before randomization; 19. Fasting triglycerides ≥ 5.6 mmol/L before randomization; 20. HIV infection (HIV-Ab positive), hepatitis C virus infection (HCV-RNA positive), Treponema pallidum infection (Treponema pallidum antibody positive), or hepatitis B virus infection (HBsAg or HBV-DNA positive) at screening or before randomization; 21. Creatine kinase (CK) levels more than 3 times the ULN before randomization; 22. Thyroid-stimulating hormone (TSH) levels below the lower limit of normal (LLN) or more than 1.5 times the ULN before randomization; 23. Significant abnormalities in laboratory test indicators at screening or before randomization, deemed unsuitable for participation in this study by the investigator; 24. Recent history (within the past year) of drug or alcohol abuse or dependence; 25. Pregnant or breastfeeding women; 26. Participants who have participated in any drug or medical device clinical trial within 3 months prior to screening (participation in a clinical trial is defined as the participant receiving treatment with the investigational drug/device), or who have been exposed to the investigational drug for less than 5 half-lives before screening, whichever is longer; 27. Participants who, as determined by the investigator, are noncompliant or have any other factors that make them unsuitable for participation in the trial, including but not limited to participation that would place the participant at unacceptable risk or could interfere with study evaluations, procedures, or completion.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Lipoprotein disorder are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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, 710061, China

  • The Second Affiliated Hospital of AFMU

    Xi’an, Shanxi, 710038, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.