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Weight-Loss drug may also protect heart arteries

NCT ID NCT07657676

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time

Summary

This study tests whether mazdutide, a weekly injection that helps with weight loss, can slow the buildup of fatty plaque in the heart arteries of 116 overweight or obese adults with coronary heart disease. Participants will receive either the drug or a placebo for 52 weeks, and doctors will use CT scans to measure changes in plaque and inflammation. The goal is to see if this drug can do more than just help with weight—it might also protect the heart.

What this could mean

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

Active substance
Mazdutide (a weekly injection that targets gut hormones to help with weight and metabolism)
What this could lead to
If it works, this could point toward a treatment that slows heart disease progression in people who are overweight.
What could go wrong
This is a small, early-phase trial with only 116 participants, so results may not apply widely. The drug may not reduce plaque or could cause side effects like nausea or injection-site reactions.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 116 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

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. Age ≥ 18 years 2. BMI ≥ 28 kg/m2 or BMI≥ 24kg/m2 with at least one of the following conditions: dyslipidemia, metabolic associated fatty liver disease, hypertension, prediabetes, type 2 diabetes mellitus, or obesity-related obstructive sleep apnea syndrome (at screening or within 6 months prior to screening). 3. Coronary stenosis 30-70% confirmed by CAG or CCTA within 3 months prior to enrollment. 4. Signed informed consent 5. Willing to comply with follow-up Exclusion Criteria: 1. History or evidence of the following : 1. A history of severe hypoglycemia, or recurrent symptomatic hypoglycemia (≥2 episodes) within the past six months 2. Severe heart disease as determined by the investigator, including coronary artery disease that has undergone or is planned for coronary artery bypass grafting or percutaneous coronary intervention, valvular heart disease requiring valve repair or replacement, heart transplantation, severe heart failure (NYHA III-IV) or cardiogenic shock, or a known history of left ventricular ejection fraction ≤30% 3. A hemorrhagic/ischemic stroke or transient ischemic attack within six months prior to screening 4. A history of acute or chronic pancreatitis, gallbladder/bile duct disease, or pancreatic injury 5. Presence of severe diseases such as malignant tumors, lymphoma, liver cirrhosis, HIV-positive status, etc., with an expected survival of less than 2 years 6. Contraindications to GLP-1/GCG dual receptor agonists, such as hypersensitivity or severe intolerance 7. A personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 2. Use of the following medications or treatments prior to screening : 1. Use of weight-affecting medications (e.g., systemic steroids, tricyclic antidepressants, psychiatric/sedative medications, etc.) within three months prior to screening 2. Use of GLP-1 RA or GIP/GLP-1 RA (exposure to investigational drugs) within three months prior to screening 3. Participation in other clinical trials (exposure to investigational drugs) within three months prior to screening 4. Known clinically significant abnormal gastric emptying or current use of medications that directly affect gastrointestinal motility 3. Laboratory test results meeting any of the following criteria at screening (repeat testing within one week is permitted if there is a clear reason, and the reason for retesting must be documented by the investigator) 1. Serum calcitonin ≥50 ng/L (pg/mL) 2. ALT/AST \>3.0 × ULN 3. eGFR \<30 mL/min/1.73m² 4. Abnormal thyroid function (TSH \>6 mIU/L or \<0.4 mIU/L) 4. Pregnancy, planned pregnancy, or breastfeeding 5. Contraindications to CCTA, including severe allergy to iodine contrast agents, presence of cardiac implantable electronic devices or other metal implants that may affect image analysis 6. Inability to complete the study or comply with study requirements as determined by the investigator Exclusion criteria for the PET-CT substudy: All exclusion criteria of the main study, as well as contraindications to PET-CT examination

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Conditions

The condition(s) this trial relates to.

coronary artery disorder coronary atherosclerosis Coronary Disease Obesity obesity disorder Overweight Plaque, Amyloid

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.

  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, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College

    Beijing, Beijing Municipality, 100037, China

More trials for these conditions

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