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Massive study pits diabetes drugs against each other for heart protection

NCT ID NCT07096063

Knowledge-focused Sponsor: Brigham and Women's Hospital Source: ClinicalTrials.gov ↗

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looked at real-world medical records from over 887,000 people with type 2 diabetes, overweight, and heart risk to compare two drugs: tirzepatide and semaglutide. The goal was to see which one better prevents serious heart problems like heart attack, stroke, or death. The study did not give anyone new treatment but instead analyzed existing data to learn how to use real-world information for future research.

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.

Participants

887,132 people

The number who actually took part.

Started

Oct 2024

Finished

Jul 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Individuals typically treated in clinical practice who are at cardiovascular risk with type 2 diabetes mellitus and overweight.

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.

ELIGIBILITY FOR TIRZEPATIDE VS DULAGLUTIDE Inclusion criteria * History of MI, stroke, any surgical or percutaneous revascularization procedure, use of any antihypertensive/lipid-lowering drugs, coronary/carotid/peripheral artery disease, hypertension * Type 2 diabetes * BMI ≥25.0kg/m2 * Age ≥18 years * Male or female sex Exclusion Criteria: * Medullary thyroid carcinoma, MEN syndrome type 2 * Malignancy * Type 1 diabetes or secondary diabetes * Chronic kidney disease or dialysis * Uncontrolled diabetic retinopathy or maculopathy * Pregnancy * Prior use of pramlintide or any GLP-1-RA ELIGIBILITY FOR SEMAGLUTIDE VS SITAGLIPTIN Inclusion Criteria: * History of MI, stroke, any surgical or percutaneous revascularization procedure, use of any antihypertensive/lipid-lowering drugs, coronary/carotid/peripheral artery disease, hypertension * Type 2 diabetes * BMI ≥25.0kg/m2 * Age ≥18 years * Male or female sex Exclusion Criteria: * Medullary thyroid carcinoma, MEN syndrome type 2 * Malignancy * Type 1 diabetes or secondary diabetes * Chronic kidney disease or dialysis * Uncontrolled diabetic retinopathy or maculopathy * Pregnancy * Prior use of pramlintide or any GLP-1-RA or DPP4i ELIGIBILITY FOR TIRZEPATIDE VS SEMAGLUTIDE Inclusion Criteria: * History of MI, stroke, any surgical or percutaneous revascularization procedure, use of any antihypertensive/lipid-lowering drugs, coronary/carotid/peripheral artery disease, hypertension * Type 2 diabetes * BMI ≥25.0kg/m2 * Age ≥18 years * Male or female sex Exclusion Criteria: * Medullary thyroid carcinoma, MEN syndrome type 2 * Malignancy * Type 1 diabetes or secondary diabetes * Chronic kidney disease or dialysis * Uncontrolled diabetic retinopathy or maculopathy * Pregnancy * Prior use of pramlintide or any GLP-1-RA

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Conditions

The condition(s) this trial relates to.

Overweight type 2 diabetes mellitus

As listed by the trial registrant

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

Cardiovascular (CV) risk Overweight Type 2 diabetes

Contacts and locations

Locations

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02120, United States

More trials for these conditions

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