J2A-MC-GZGS: A Phase 3, Open-Label Study of Once Daily Orforglipron Compared with Insulin Glargine in Adult Participants with Type 2 Diabetes and Obesity or Overweight at Increased Cardiovascular Risk (ACHIEVE-4)
This important study, called ACHIEVE-4, is looking into a new daily medicine called Orforglipron for adults with type 2 diabetes. Participants who are also overweight or obese and have a higher chance of heart problems will be involved. The researchers want to see how well Orforglipron helps prevent serious heart issues like heart attacks or strokes, compared to a common insulin treatment called Glargine. It's an 'open-label' study, meaning everyone will know which medicine they are taking. This research aims to find better ways to manage type 2 diabetes and related heart risks.
At a glance
What is this study about?
This study is a type of research called a 'Phase 3 trial', which means it's one of the final steps before a new medicine might be approved for wider use. It's focusing on a new treatment called Orforglipron. This medicine is being tested in adults who have type 2 diabetes, a common condition where the body doesn't use sugar properly. Participants also need to be overweight or obese, and have a higher risk of developing heart and blood vessel problems.
The main goal of the study is to see if Orforglipron can help reduce the chance of serious heart issues. These include things like having a heart attack, a stroke, needing to go to hospital for unstable chest pain, or even death related to heart problems. The researchers will be comparing Orforglipron with a type of insulin called Glargine, which is already used to treat diabetes.
By comparing these two treatments, the study hopes to find out if Orforglipron is a safe and effective option that could improve the health of people with type 2 diabetes who are also at risk of heart disease. Finding new ways to manage both diabetes and heart health is really important for improving people's quality of life.
Key takeaways
- Tests a new medicine (Orforglipron) for type 2 diabetes.
- Compares it to existing insulin (Glargine).
- Focuses on adults who are overweight/obese with heart risks.
- Aims to prevent serious heart problems like heart attacks and strokes.
- It's a large, late-stage study (Phase 3).
- Participation involves daily medicine and regular health checks.
Who may be eligible?
To join this study, you need to be an adult, aged 18 or older, regardless of your gender. You must have type 2 diabetes, a condition where your body doesn't properly use sugar for energy.
It's also important that you are either overweight or obese. This study is specifically looking at how the new medicine works in people who have these conditions alongside their diabetes.
Additionally, you will need to have some factors that put you at a higher risk of developing heart and blood vessel problems. A doctor involved in the study would check all these details to see if this study is 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 type 2 diabetes?
- Are you considered overweight or obese?
- Has your doctor told you that you have an increased risk of heart problems?
What does participation involve?
If you decide to take part, you would be given either the new medicine, Orforglipron, as a once-daily treatment, or an existing insulin medicine called Glargine. This is an 'open-label' study, which means both you and your study doctor would know which medicine you are receiving.
You would have regular visits to the clinic for health checks, blood tests, and to review how you're feeling and how the medicine is working. These visits might also involve other health assessments to monitor your heart health and diabetes control. The study will look closely at how long it takes for a serious heart event to happen, if at all.
The total length of time you would be in the study can vary, but these types of trials often last for a few years to properly track long-term effects. You would receive detailed information about the schedule of visits and what each visit involves before making any decisions.
Potential risks and benefits
Locations (8)
- —UnverifiedGreece
- —UnverifiedGermany
- —UnverifiedAustria
- —UnverifiedRomania
- —UnverifiedSlovakia
- —UnverifiedCzechia
- —UnverifiedSpain
- —UnverifiedItaly
Common questions
What is Orforglipron?
Orforglipron is a new medicine being tested to help manage type 2 diabetes and potentially reduce the risk of heart problems.
What is type 2 diabetes?
Type 2 diabetes is a common condition where your body doesn't produce enough insulin or doesn't use insulin properly, leading to high blood sugar levels.
What does 'increased cardiovascular risk' mean?
It means you have a higher chance of developing heart and blood vessel problems, such as heart attacks or strokes, often due to other health conditions.
Will I know which medicine I'm taking?
Yes, this is an 'open-label' study, so both you and the study team will know whether you are taking Orforglipron or insulin Glargine.
What kind of heart problems are they looking for?
They are specifically looking for serious heart events like heart attacks, strokes, hospital stays for severe chest pain, or death related to heart issues.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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