Weight-Loss drug may also protect heart arteries
NCT ID NCT07657676
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 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. 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Coronary atherosclerosis are added.
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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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.
- Can a Very-Low-Carb diet reverse prediabetes? trial puts it to the test
- Can you keep the weight off after stopping GLP-1 drugs? scientists test three exit plans
- Can a stearic Acid-Rich diet improve blood vessel health?
- Can a High-Phenolic ancient grain rewire metabolism?
- Can a tiny fat sample predict childhood obesity?
- Can cooking classes curb dangerous pregnancy weight gain?