CompletedPhase IVInterventional

ASCEND PLUS - a research study to test whether a treatment called oral semaglutide can protect people with type 2 diabetes from heart attacks, strokes, and other health problems

ASCEND PLUS is a large UK clinical trial run by the University of Oxford. It is testing whether taking a daily tablet called semaglutide can help protect people with type 2 diabetes from future heart attacks, strokes, and mini-strokes. Semaglutide is already widely used in the UK to help manage blood sugar levels and weight. The study aims to involve 20,000 adults aged 55 and older who have type 2 diabetes and have never had a heart attack or stroke in the past. Taking part is designed to be simple and convenient. There are no clinic or hospital visits required. Study tablets are posted directly to your home, and you will take one tablet daily for about five years. You will also fill out around 12 short health questionnaires during the study. Half of the participants receive semaglutide, and half receive an inactive dummy tablet (placebo).

At a glance

Status

Completed

Phase

Phase IV

Sponsor

University of Oxford

Enrolment target

20,000

Start

13 Mar 2023

Estimated completion

17 Jun 2026

Type 2 diabetes

What is this study about?

Type 2 diabetes is a lifelong condition that causes the level of sugar in the blood to become too high. Over time, high blood sugar can damage blood vessels and raise the risk of serious cardiovascular problems, including heart attacks and strokes. Finding safe, simple ways to protect the heart and circulation is an important goal in diabetes care.

The ASCEND PLUS trial is investigating whether a medicine called semaglutide can offer long-term protection against these problems. Semaglutide is already approved in the UK to help control blood sugar and support weight loss. Researchers now want to find out if taking it as a daily tablet can also prevent heart disease and strokes in people who have not previously experienced them.

This nationwide study is led by the University of Oxford and will include 20,000 volunteers. Half of the volunteers will receive semaglutide tablets, while the other half will receive dummy tablets known as placebos. By comparing the two groups over five years, researchers will be able to see clearly whether the active medicine provides meaningful protection. The findings could help shape future NHS treatment guidelines and protect many people living with diabetes.

Key takeaways

Tests whether a daily semaglutide tablet protects against first-time heart attacks and strokes.
Open to adults aged 55 and over with type 2 diabetes who have never had a stroke or heart attack.
Completely home-based with no hospital or clinic visits required.
Study medication is delivered straight to your door by post for around five years.
Run by the University of Oxford and funded by Novo Nordisk.

Who may be eligible?

You may be eligible to join ASCEND PLUS if you are 55 years of age or older and have been diagnosed with type 2 diabetes. Because this trial looks at preventing cardiovascular problems before they first happen, you must not have had a heart attack or a stroke in the past.

The trial is not suitable for everyone. You cannot take part if you have type 1 diabetes, severe heart failure, or severe kidney disease. You also cannot join if you are already taking or planning to start a similar diabetes medicine (called a GLP-1 treatment), if you have had recent cancer treatment, or if you are pregnant or breastfeeding.

Most participants will be invited following a search of NHS records, but your own GP will always be consulted before you join to make sure taking part is safe and right for your health.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am aged 55 or older.
I have been diagnosed with type 2 diabetes.
I have never suffered a heart attack or a stroke.
I am not currently taking or planning to take a GLP-1 diabetes treatment.
I am not pregnant, planning a pregnancy, or breastfeeding.

Answer every question to see your result.

What does participation involve?

Taking part in ASCEND PLUS lasts for about five years and is designed to fit smoothly into your everyday routine. There are no hospital visits or clinic appointments required. All study tablets are posted directly to your home address in discreet packaging.

You will be asked to take one tablet each day. To keep the study fair and unbiased, half of the volunteers will take semaglutide and half will take a placebo tablet that looks identical. A computer chooses your group at random, and neither you nor the research team will know which tablet you are taking. Over the five years, you will also complete around 12 brief health questionnaires online or on paper. You will continue seeing your usual GP and diabetes team for all your standard NHS care.

Potential risks and benefits

Taking part may help improve your blood sugar levels and could reduce your chance of having a heart attack or stroke, although personal health benefits cannot be promised. The findings will help doctors better protect people with diabetes in the future. Semaglutide is generally safe, but around one in ten people experience mild stomach side effects such as nausea, sickness, or diarrhoea, especially in the first few weeks. Rapidly improving blood sugar can also temporarily affect eye health, so it is important to keep attending your regular NHS diabetic eye screening. Taking part is completely voluntary, and you are free to stop at any time without your normal NHS care being affected.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

ASCEND PLUS Coordinating Office
City only
Oxford, England

Common questions

Do I need to travel to a clinic or hospital for this trial?

No. The entire study is conducted from home. Study tablets are sent to you by post, and health questionnaires are completed online or by mail.

What is a placebo tablet?

A placebo is a dummy tablet that looks and tastes identical to the active medicine but contains no active drug. It allows researchers to see whether any health changes are genuinely caused by semaglutide.

Can I continue taking my regular prescription medicines?

Yes. You should carry on taking all your usual medications as prescribed by your doctor, unless your GP or diabetes team specifically advises otherwise.

What should I do if the study tablets make me feel unwell?

Mild digestive issues often settle after a short time. However, you can contact the study medical helpline at any time for advice, and you can pause or stop taking the tablets whenever you wish.

Will taking part interfere with my standard NHS diabetes care?

No. Your regular NHS appointments, blood tests, and annual diabetes reviews will continue as normal alongside the study.

How to find out more

Ryonfa Lee

ascend-plus@ndph.ox.ac.uk +44 1865 743743 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.