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Diabetes pill could slash heart attack risk in millions
NCT ID NCT05441267
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 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: * 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
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