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Diabetes pill could slash heart attack risk in millions

NCT ID NCT05441267

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing whether a daily semaglutide tablet can safely reduce the risk of heart attacks, strokes, and related deaths in over 21,000 adults with type 2 diabetes who have never had a heart attack or stroke. Participants take either semaglutide or a placebo pill for several years. The goal is to see if this medication, already used for diabetes, can 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
Semaglutide oral tablet
What this could lead to
If successful, this could provide a simple daily pill to lower the risk of heart attacks and strokes in people with type 2 diabetes.
What could go wrong
This is a large, late-stage trial, but results are not yet available. Semaglutide can cause side effects like nausea or vomiting, and it may not prove effective for everyone.

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

21,296 people

The number who actually took part.

Started

Mar 2023

Expected to finish

Aug 2048

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.

Ages

55 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: * Adults aged at least 55 years at the time of the Screening assessment * Type 2 Diabetes Mellitus (based on self-reported medical history) Exclusion criteria: * Myocardial Infarction * Stroke * Current or planned treatment with a GLP-1 RA * Previous hypersensitivity to or intolerance of GLP-1 RA therapy * Severe hypoglycaemia within the last six months or during run-in * Symptomatic hypoglycaemia within the last month * Currently under consideration to commence insulin * Severe heart failure (NYHA class 4) * Current or planned renal replacement therapy * Unwilling to complete regular follow-up assessments * Ongoing treatment for cancer or diagnosis with cancer (excluding non-melanoma skin cancer) in the last 2 years * Type 1 or other type of diabetes (e.g. MODY) * History of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma * Currently breastfeeding or pregnant, or planning a pregnancy * Any serious illness which is likely to limit survival or active participation for at least 5 years * Current participation in a clinical trial with an unlicensed investigational medicinal product used to treat diabetes * For participants taking thyroxine, lack of agreement to arrange a thyroid function test in the next 3 months and agree to regular testing throughout the trial * Non-adherence to run-in treatment (i.e. reports taking the run-in tablets 'Never' or 'Only occasionally') * Their doctor does not wish them to be randomised

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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.

Contacts and locations

Locations

  • Clinical Trial Service Unit and Epidemiological Studies Unit

    Oxford, United Kingdom

More trials for these conditions

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