Active not recruitingPHASE3INTERVENTIONAL

REDEFINE 3: A Research Study to See the Effects of CagriSema in People Living With Diseases in the Heart and Blood Vessels

The REDEFINE 3 study is looking into a new medicine called CagriSema for individuals living with heart and blood vessel diseases, also known as cardiovascular disease. The main goal is to find out if CagriSema can lower the chance of experiencing serious health problems such as heart attacks or strokes. Participants will receive either CagriSema or a dummy medicine (placebo) by weekly injection, decided randomly. The study will last for up to four and a half years. This research is important because it could offer a new way to protect people at risk of cardiovascular events.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Novo Nordisk A/S

Enrolment target

7,101

Start

01 Mar 2023

Estimated completion

13 Oct 2027

Cardiovascular Disease

What is this study about?

The REDEFINE 3 study is an important research project focusing on a new medicine called CagriSema. This medicine is being investigated for its potential to help people who have heart and blood vessel diseases. These conditions, known as cardiovascular diseases, can lead to serious health issues like heart attacks and strokes. The study aims to understand if CagriSema can reduce the risk of these events happening.

Participants in the study will be given either CagriSema or a 'dummy' medicine known as a placebo. A placebo looks like the study medicine but doesn't contain any active ingredients, so it has no effect on the body. This is a common practice in medical research to fairly compare the new medicine to not receiving treatment. The decision of whether a participant receives CagriSema or the placebo will be made randomly, meaning there's an equal chance of getting either one.

This is a long-term study, designed to run for up to four and a half years. Over this period, researchers will carefully monitor participants to see how CagriSema affects them and if it can indeed lower the risk of cardiovascular events. The information gathered from this study will be crucial in determining if CagriSema could become a new treatment option for people with these conditions, ultimately helping to improve their health and quality of life.

Key takeaways

Tests a new medicine, CagriSema, for heart and blood vessel diseases.
Aims to reduce the risk of heart attack and stroke.
Participants receive CagriSema or a dummy medicine by weekly injection.
The study will run for up to 4.5 years.
For people aged 55+ with existing heart or blood vessel disease.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you need to be a man or woman aged 55 years or older. You also need to have a Body Mass Index (BMI) of 25 or more, which is a measure of your weight in relation to your height. Most importantly, you must have an existing heart or blood vessel disease, such as having had a previous heart attack or stroke, or have issues with blood circulation in your legs, like pain when walking or needing a procedure to improve blood flow to your legs.

If you also have Type 2 Diabetes, there are a few extra requirements. You must have been diagnosed with Type 2 Diabetes at least six months before the study starts, and your blood sugar control, measured by a test called HbA1c, needs to be within a specific range. You should also be managing your diabetes through lifestyle changes, or with certain oral medicines, or with basal insulin, either alone or with up to two oral medicines.

There are also some reasons why you might not be able to join. For example, if you've had a recent heart attack, stroke, or severe chest pain (unstable angina) within the last two months, you won't be eligible. Also, if you know you need to have a procedure to improve blood flow to your heart, brain, or legs in the near future, you wouldn't be able to participate.

Quick self-check

Are you 55 years old or older?
Do you have a BMI of 25 or more?
Have you had a heart attack, stroke, or circulation problems in your legs?
If you have Type 2 Diabetes, was it diagnosed at least 6 months ago and is your blood sugar (HbA1c) in range?
Have you NOT had a recent heart attack or stroke in the last 2 months?
Do you NOT have a planned heart, brain, or leg blood vessel procedure coming up?

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 in this study, you will be asked to inject the study medicine (either CagriSema or a placebo) once a week. These injections are given with a fine needle, and you can typically do this yourself in your stomach, thigh, or upper arm. The study will involve regular check-ups and assessments to monitor your health and the effects of the treatment. The total duration of your participation in this study could be for up to four and a half years.

Potential risks and benefits

Taking part in a clinical trial like REDEFINE 3 could offer potential benefits, such as receiving a new investigational medicine that might help reduce your risk of serious cardiovascular events. You will also receive close medical attention and monitoring throughout the study. However, there are also potential risks, including side effects from the study medicine, or the possibility that CagriSema may not be effective for you. You will be fully informed about all known risks before deciding to participate. Remember, your participation is voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (631)

Univ of Alabama Birmingham
Birmingham, United States
Chambliss Clinical Trials LLC
Montgomery, United States
Honor Health
Scottsdale, United States
National Heart Institute Cal
Beverly Hills, United States
Valley Clinical Trials
Covina, United States
Scripps Wht Diab Inst La Jolla
La Jolla, United States
First Valley Medical Group
Lancaster, United States
Clinical Trials Research_Sacramento
Lincoln, United States
Torrance Clin Res Inst, Inc.
Lomita, United States
Pacific Clinical Studies
Los Alamitos, United States
Monterey Endocrine & Diabetes Institute, Inc
Monterey, United States
Valley Clinical Trials, Inc.
Northridge, United States

+619 more sites — see the official record for the full list.

Common questions

What is CagriSema?

CagriSema is a new investigational medicine that scientists are studying to see if it can help people with heart and blood vessel diseases.

What is a placebo?

A placebo is a 'dummy' medicine that looks like the real treatment but contains no active ingredients. It's used in studies to fairly compare the new medicine to not receiving treatment.

How is the medicine given?

The study medicine is given as an injection once a week, usually into the stomach, thigh, or upper arm.

How long does the study last?

The study will last for up to four and a half years.

Will I know if I'm getting the real medicine or the placebo?

No, it's decided by chance, and neither you nor the study team will know which treatment you are receiving until after the study is complete. This helps ensure the study results are unbiased.