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Which diabetes drug protects the heart better? large study aims to find out

NCT ID NCT06980623

Disease control 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 large study compares two popular diabetes drugs, tirzepatide and semaglutide, in 26,000 people who have both type 2 diabetes and a type of heart failure. Researchers will track who ends up in the hospital for heart failure or dies, to see if one drug works better. The goal is to help doctors choose the best treatment for patients with these two conditions.

What this could mean

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

Active substance
tirzepatide and semaglutide
What this could lead to
If this study shows one drug is clearly better, it could guide doctors to prescribe the more effective option for patients with both diabetes and heart failure.
What could go wrong
This is an observational study, not a controlled trial, so results may be influenced by other factors. It also does not test a new drug, just compares existing ones.

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

About 26,000 people

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

Started

Jan 2025

Expected to finish

Oct 2026

An estimate. End dates often move.

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

Patients \> 18 years old with T2D and HFpEF.

Ages

18 years and older

Sex

Anyone

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: * Patients who are new users of tirzepatide or new users of semaglutide * Patients with diagnosis of T2D and HFpEF, i.e., EF \>= 45%. * Age \>= 18 years old * Patients with continuous health plan enrollment before and including the treatment initiation date Exclusion Criteria: * Patients with missing age or sex information * Patients with type 1 diabetes mellitus, secondary or gestational diabetes * History of diabetes related complications * Patients with related chronic diseases. * History of gastrointestinal conditions. * Previous exposure to other GLP-1RA and pramlintide * Patients with prescription dispensing for both tirzepatide and semaglutide on cohort entry date

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder diastolic heart failure heart failure type 2 diabetes mellitus

As listed by the trial registrant

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

Heart failure 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.