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New shot could cut heart attacks and strokes in High-Risk patients

NCT ID NCT07551492

Disease control Sponsor: Fujian Shengdi Pharmaceutical Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 09, 2026 · Updated 3 times

Summary

This Phase 3 trial is testing an injectable drug called HRS9531 in about 9,200 people with atherosclerotic cardiovascular disease (hardened arteries). The goal is to see if it can lower the chance of major heart problems like heart attack, stroke, or death. Participants receive either the drug or a placebo shot, and the study will last until enough heart events occur to compare the groups.

What this could mean

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

Active substance
HRS9531 injection
What this could lead to
If it works, this could provide a new treatment to lower the risk of major heart problems like heart attack or stroke in people with hardened arteries.
What could go wrong
This is a large Phase 3 trial, but the drug is still experimental. It may not prove effective, and side effects are possible. Results are not expected for several years.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 9,262 people

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

Started

May 2026

Expected to finish

Jun 2031

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. Diagnosed with atherosclerotic cardiovascular disease (ASCVD) 2. The body mass index (BMI) at the time of screening was ≥24.0 kg/m ². Patients with type 2 diabetes have a BMI of ≥22.0 kg/m ² Exclusion Criteria: 1. Screening for myocardial infarction, acute decompensated heart failure, hospitalization due to heart failure, unstable angina pectoris, stroke or transient ischemic attack, coronary revascularization, atrial flutter/fibrillation ablation, valve repair/replacement, carotid or peripheral artery recanalization within 30 days prior to the screening 2. Severe hypoglycemic events or recurrent hypoglycemic events occurred within one month before screening 3. When screening, there are proliferative retinopathy or macular degeneration requiring acute treatment, painful diabetic neuropathy, diabetic foot ulcers 4. Coronary revascularization, atrial flutter/fibrillation ablation, valve repair/replacement, and carotid or peripheral artery recanalization are planned to be performed during the trial 5. Those with a history of acute or chronic pancreatitis, acute cholecystitis, or symptomatic or treatment-requiring gallbladder diseases 6. Any malignant tumor of the organ system has occurred within the past five years, regardless of whether there is evidence of local recurrence or metastasis, except for cured local cutaneous basal cell carcinoma and cervical carcinoma in situ 7. Pregnant or lactating women, or participants with fertility who are unwilling to take effective contraceptive measures 8. Those who have had any previous conditions that affected gastric emptying or have undergone gastrointestinal surgery 9. Diagnosed or suspected as type 1 diabetes, special type diabetes or secondary diabetes 10. Acute complications of diabetes occurred within one month before screening 11. There are endocrine diseases that may significantly affect weight

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Conditions

The condition(s) this trial relates to.

atherosclerosis atherosclerotic cardiovascular disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atherosclerotic cardiovascular disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Fuwai Hospital, CAMS&PUMC

    RECRUITING

    Beijing, Beijing Municipality, 100037, China

More trials for these conditions

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