J1I-MC-GZBK: A Master Protocol to Investigate the Efficacy and Safety of LY3437943 Once Weekly in Participants with Type 2 Diabetes Mellitus Who Have Obesity or Overweight: A Randomized Double-Blind, Placebo-Controlled Trial (TRIUMPH-2)
This research study, called TRIUMPH-2, is investigating a new medicine called Retatrutide. This medicine is given as an injection once a week. It's designed for adults who have type 2 diabetes and are also overweight or obese. The main purpose of the study is to carefully check how much weight people lose when taking Retatrutide compared to those who receive a placebo, which is a dummy injection with no active medicine. The study will also look at how safe the new medicine is. This is a Phase 3 study, meaning it’s one of the final steps before a medicine might become widely available, if it proves to be safe and effective. It's important to understand if this new treatment could offer a good option for managing weight in people with type 2 diabetes.
At a glance
What is this study about?
This study is a very important next step in understanding a new medicine called Retatrutide. It's given as a weekly injection and is being tested for adults over 18 who have type 2 diabetes and are also overweight or obese. The main aim is to see if this new medication can help people lose a significant amount of weight, and to make sure it's safe to use.
Type 2 diabetes often comes with challenges like managing weight, which can make the condition harder to control and lead to other health problems. Researchers are always looking for better ways to help people with type 2 diabetes improve their health. This study compares Retatrutide to a 'placebo', which is a dummy injection that looks exactly like the real one but contains no active medicine. This comparison helps scientists know for sure if any changes people experience are due to the new medicine or something else.
This kind of study is called a 'Phase 3' trial. This means the medicine has already been tested in smaller groups of people and shown some promising results. Phase 3 trials involve many more people to confirm that the medicine is effective and safe enough for it to potentially be approved for wider use in the future. By participating, you could help doctors learn more about managing type 2 diabetes and obesity effectively.
Key takeaways
- This study is testing a new weekly injection (Retatrutide) for type 2 diabetes and weight management.
- It's for adults 18+ who have type 2 diabetes and are also overweight or obese.
- The main goal is to see how much weight people lose and how safe the medicine is.
- Participants will receive either the new medicine or a dummy injection (placebo).
- Close medical monitoring and regular clinic visits will be part of the study.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
This study is looking for adult volunteers, aged 18 or older, regardless of whether they are male or female. You would need to have a diagnosis of type 2 diabetes.
Additionally, you must be either overweight or obese. Your doctor or the study team will be able to check your body mass index (BMI) to confirm if you meet the specific weight criteria for the study.
There will be other detailed health checks to make sure the study is a safe and suitable option for you. The study team will discuss all these checks with you in full and answer any questions you may have.
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 type 2 diabetes?
- Are you currently overweight or obese?
- Are you able to attend regular clinic appointments?
What does participation involve?
If you decide to take part in this study, you would first have a full medical check-up to make sure it’s suitable for you. During the study, you would receive either the new medicine (Retatrutide) or a dummy injection (placebo) once a week. Neither you nor your study doctor would know which one you are receiving – this is called 'double-blind' and helps ensure fair results. You would receive these injections for a set period, and there would be regular visits to the clinic.
During these visits, the study team would carefully monitor your health, check your weight, take blood tests, and ask about any changes you notice. They would also provide you with all necessary study medication. After the main treatment period, there will be a follow-up period to continue checking your health and progress. The total duration of your participation, including all visits and follow-ups, would be explained to you in detail by the study team before you make any decisions.
Potential risks and benefits
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Common questions
What is Retatrutide?
Retatrutide is a new investigational medication, given as a weekly injection, being tested to see if it helps with weight loss in people with type 2 diabetes.
What does 'placebo-controlled' mean?
It means some participants will receive the active medicine, and others will receive a dummy injection (placebo) that looks identical but contains no medicine. This helps researchers compare the effects accurately.
Will I know if I'm getting the real medicine or the placebo?
No, this is a 'double-blind' study, meaning neither you nor your study doctor will know which treatment you are receiving until after the study is complete, to ensure unbiased results.
What is a Phase 3 study?
A Phase 3 study is a large research trial that includes many people. It's one of the final steps to confirm if a new medicine is safe and effective enough to be approved for general use.
How long would I be in the study?
The exact duration of your participation, including treatment and follow-up visits, will be explained in full by the study team. It typically involves several months.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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