Not yet recruitingPHASE4INTERVENTIONAL

DECODE - Haemodynamic Effects Of Semaglutide and Tirzepatide - a Series of Pilot Studies

This research, called 'Decode', is investigating how medications like semaglutide and tirzepatide, used for weight loss and diabetes, affect blood pressure and blood vessels. While these drugs are known to help people lose weight and lower blood pressure, scientists want to find out if there's a direct effect on the heart and blood system that isn't just due to weight loss. The study will look at how these drugs influence blood flow in the arm and their overall effects on the body. Different groups of people will take part, including those with normal weight, and those with obesity, with or without high blood pressure, to get a full picture of their effects.

At a glance

Status

Not yet recruiting

Phase

PHASE4

Sponsor

Cambridge University Hospitals NHS Foundation Trust

Enrolment target

112

Start

01 Mar 2026

Estimated completion

01 Apr 2028

Cardiovascular Diseases

What is this study about?

High blood pressure is a major health concern, affecting many adults in the UK. Being overweight or having obesity is closely linked to high blood pressure. While healthy eating and weight loss are often recommended, it can be hard to lose weight and keep it off. This means we need more ways to help people manage their weight and blood pressure.

New medications, like semaglutide and tirzepatide, originally used for type 2 diabetes, have been very successful in helping people lose significant weight. What's also been noticed is that they often lead to a big drop in blood pressure. This study aims to understand why this happens. Is it simply because people lose weight, or do these drugs have special qualities that directly help blood vessels and the heart?

By carefully studying how these medications work in the body, researchers hope to discover if they can play an even bigger role in treating both obesity and high blood pressure, potentially improving heart health for many people.

Key takeaways

This study investigates if new weight loss drugs directly benefit blood pressure and heart health.
It aims to understand effects beyond just weight loss.
Participants will be adults aged 18-50, including those with obesity and/or high blood pressure.
Involvement can range from 2 days to approximately 2.5 months.
The research could lead to a better understanding of high blood pressure and obesity treatments.

Who may be eligible?

This study is looking for adults aged 18 to 50 years. Researchers are particularly interested in three groups of people: those who are a healthy weight with normal blood pressure, those who have obesity but normal blood pressure, and those who have both obesity and high blood pressure (specifically, stage 1 high blood pressure).

There are some important things that might mean you can't take part. For example, you shouldn't be a smoker. If you're a woman who could get pregnant, you'll need to use reliable contraception and have a negative pregnancy test at each visit. You also can't be taking certain heart or blood pressure medications (or you might need to temporarily stop them if your doctor agrees). You also can't have serious heart valve problems, an implanted pacemaker, active cancer, or severe kidney issues.

Quick self-check

Are you between 18 and 50 years old?
Do you not smoke?
If you're a woman, are you using reliable contraception (if needed) and willing to have pregnancy tests?
Do you not have a pacemaker, serious heart valve disease, or active cancer?
Are you able to pause certain heart medications for study visits (if applicable, and your doctor agrees)?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, your involvement could last from a minimum of 2 days to about 2 to 2.5 months, depending on which part of the study you're in. The study involves a few different visits where researchers will give you either semaglutide or tirzepatide and monitor how your blood vessels and heart respond. Some visits might involve infusing the drugs directly into an arm artery, while others will involve giving the drugs through your general circulation. You will have regular checks, including blood tests and measurements of your blood pressure and heart function. There will also be a follow-up phone call after your last visit. The overall study is expected to run for about 18 months, but your personal participation within that timeframe will be shorter.

Potential risks and benefits

Taking part in a study like this could potentially help scientists learn more about how these new medications affect heart health, which might lead to better treatments for high blood pressure and obesity in the future. As with any medication, there can be side effects, which the study team will fully explain. You might experience some discomfort from blood tests or monitoring. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Addenbrooke's Hospital
Cambridge, United Kingdom

Common questions

What are semaglutide and tirzepatide?

These are medications commonly used to treat type 2 diabetes, and they have also been found to help people lose weight and improve blood sugar control.

What does 'haemodynamic effects' mean?

This refers to how blood flows through your body and how your heart and blood vessels work to control it, including blood pressure.

Will I receive treatment for my high blood pressure during the study?

The study is looking at the effects of the specific medications. If you have high blood pressure, discussions will be had with you and your doctor about managing your medication around the study visits.

How long will I need to be in the study?

Your involvement could range from just 2 days to about 2.5 months, depending on the specific part of the study you participate in.

Will I get paid for taking part?

The study information doesn't mention payment, but you should ask the research team about any compensation for time or travel.

How to find out more

Guneswary Thaygaraja, Msc Genomic Medicine

cuh.cambs.cardiovascular@nhs.net 01223 349762 Official trial record

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