J1I-MC-GZBM: A Randomized, Double-Blind, Phase 3 Study to Investigate the Efficacy and Safety of LY3437943 Once Weekly Compared to Placebo in Participants with Severe Obesity and Established Cardiovascular Disease (TRIUMPH-3)
This research study, called TRIUMPH-3, is investigating a new treatment named Retatrutide. It's an injection given once a week. The study focuses on people who have severe obesity and also established heart (cardiovascular) disease. We want to find out if this new medicine can help them lose weight effectively and safely. To do this, some people will receive the new medicine, while others will get a 'dummy' injection (placebo) that looks the same but contains no active drug. This helps us compare the new treatment's effects. Researchers will carefully check how much weight participants lose. The study is in its final main stage before a new medicine might become widely available.
At a glance
What is this study about?
This study is called TRIUMPH-3, and it's a very important step in seeing if a new medicine can help people with severe obesity and existing heart conditions. Severe obesity can put a lot of strain on your body, including your heart, and can lead to serious health problems. We're looking for new and effective ways to help manage both of these conditions.
The new medicine being tested is called Retatrutide. It's given as a simple injection once a week. The main goal of this study is to see how well Retatrutide helps people lose weight compared to a 'dummy' injection, which has no medicine in it. By comparing the two, doctors can understand if the weight loss seen is truly due to the new medicine or other factors. We also carefully monitor the health and safety of everyone taking part throughout the study.
This type of study is called a 'Phase 3' study. It means it's one of the final and largest steps before a new medicine might be approved for general use. These studies are crucial because they involve many people and provide clear information about whether a new treatment works and is safe for a wider group of patients. It means scientists have already done earlier tests to check its basic safety.
Key takeaways
- This study is testing a new weekly injection, Retatrutide, for severe obesity and heart problems.
- It aims to see if Retatrutide helps with weight loss and is safe.
- Participants will receive either the new medicine or a dummy injection.
- Both men and women aged 18 and over can participate if they meet health criteria.
- Regular clinic visits and health checks will be part of taking part.
Who may be eligible?
To join this study, you need to be an adult, 18 years of age or older. Both men and women can take part. A key requirement is that you must have severe obesity. This generally means having a very high Body Mass Index (BMI).
You also need to have an existing heart or blood vessel condition. This could include things like having had a heart attack, a stroke, or certain types of heart disease. The research team will review your medical history carefully to make sure you meet all the specific health criteria for the study.
There will be other detailed health checks to make sure the study is safe and suitable for you. These will be discussed fully by the study doctors and nurses, and they will explain why certain health conditions might mean the study isn't right for you.
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.
- Are you 18 years old or older?
- Do you have severe obesity (a high Body Mass Index)?
- Do you have an existing heart (cardiovascular) disease?
- Are you able to attend regular clinic appointments?
What does participation involve?
If you decide to take part in this study, you won't know whether you are receiving the active medicine (Retatrutide) or the dummy injection, and neither will your study doctor. This is called 'double-blind' and helps make sure the results are fair. You'll receive your study treatment as an injection once a week.
Your participation will involve regular visits to the clinic for health checks, blood tests, and to measure your weight. These visits will help the doctors understand how the treatment is affecting you and to monitor your safety. You will also be asked about any side effects you might be experiencing. The study will last for a specific period, which the study team will explain in full detail, including how long you will receive the medication and any follow-up appointments after that. The total duration of your participation, including follow-up, will be outlined before you agree to join.
Potential risks and benefits
Locations (4)
- —UnverifiedSlovakia
- —UnverifiedHungary
- —UnverifiedSpain
- —UnverifiedPoland
Common questions
What is Retatrutide?
Retatrutide is a new investigational medication given as a weekly injection, being studied for its effects on weight loss in people with severe obesity.
What is a 'dummy' injection (placebo)?
A dummy injection looks exactly like the real medicine but contains no active drug. It helps researchers compare the true effects of the new medication.
Will I know if I'm getting the real medicine or the dummy injection?
No, neither you nor your study doctor will know which treatment you are receiving until after the study has finished. This is standard practice in medical research.
How long will I be in the study?
The study team will explain the exact time commitment, including how long you'll receive medication and any follow-up visits, before you agree to participate.
Can I stop participating if I want to?
Yes, you can leave the study at any time, for any reason, without affecting your regular medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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