A Research Study to Look at How Well Zenagamtide Works Compared to Placebo in People With Established Atherosclerotic Cardiovascular Disease and Either Overweight or Obesity
This research study is looking at a new medicine called Zenagamtide. It's for people who have certain heart and blood vessel conditions, often called 'atherosclerotic cardiovascular disease' (like having had a heart attack, stroke, or circulation problems in the legs), and are also overweight or obese. The main goal is to find out if Zenagamtide is safe and works better than a dummy medicine (placebo) to help improve health outcomes for these patients. Half of the people taking part will get Zenagamtide, and the other half will get the placebo. This is a common way to test new medicines to see their true effects.
At a glance
What is this study about?
This study is about a new medicine called Zenagamtide. We are looking for people who have certain heart and blood vessel conditions and are also overweight or obese. These conditions are sometimes called 'atherosclerotic cardiovascular disease'. This can include things like having had a heart attack in the past, a stroke, or problems with blood flow in the legs (peripheral artery disease).
The main purpose of this study is to see if Zenagamtide is safe and if it helps people with these conditions. The medicine is still in development and isn't available from doctors yet. We will compare Zenagamtide to a 'placebo', which looks exactly like the real medicine but contains no active ingredients. This helps us understand if any changes in health are truly because of Zenagamtide or if they happen for other reasons.
By taking part, you could help doctors learn more about how to treat people with heart and blood vessel problems who are also overweight or obese. This information could lead to new ways of helping many people in the future.
Key takeaways
- This study is for people with heart/blood vessel problems and who are overweight or obese.
- It tests a new medicine called Zenagamtide against a dummy medicine (placebo).
- Participation involves regular clinic visits, taking study medication, and health checks.
- You won't know if you're getting Zenagamtide or the placebo.
- The study aims to see if Zenagamtide is safe and effective for these conditions.
Who may be eligible?
To join this study, you need to be aged 45 or over. You must also have a history of certain heart and blood vessel problems. This includes having had a heart attack, a stroke, or specific circulation issues in your legs (peripheral artery disease). If you have type 2 diabetes, you might still be able to join, but your diabetes treatment needs to have been stable for at least 3 months, and you can't be on certain types of diabetes medicines that work in a similar way to Zenagamtide.
There are also reasons why you might not be able to join. For example, if you've had a recent heart attack, stroke, or severe heart failure within the last month, or if you've had certain heart or blood vessel procedures recently. You also can't take part if you have certain types of severe heart failure, or if you've had frequent severe low blood sugar episodes, type 1 diabetes, or certain severe eye problems related to diabetes.
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 45 years old or older?
- Have you had a heart attack, stroke, or circulation problems in your legs?
- Are you currently overweight or obese?
- Have you *not* had a heart attack, stroke, or severe heart failure in the last month?
- If you have Type 2 Diabetes, has your treatment been stable for at least 3 months?
What does participation involve?
If you decide to take part in this study, you'll be assigned by chance to either receive Zenagamtide or a dummy medicine (placebo). Neither you nor your study doctor will know which one you are receiving. You will need to attend several visits to the study clinic where you'll have various health checks, such as blood tests, blood pressure measurements, and heart checks. You will be given the study medicine to take regularly. The doctors and nurses will monitor your health closely throughout the study to see how you are responding and if you experience any side effects. This is a 'Phase 3' study, which means it's one of the final steps before a medicine might be approved, and these studies often last for a significant period.
Potential risks and benefits
Locations (769)
- Uni of Alabama at BirminghamVerified postcodeBirmingham, United States
- Eastern Shore Rsrch Inst, LLCVerified postcodeFairhope, United States
- Mobile Heart SpecialistsVerified postcodeMobile, United States
- Chambliss Clinical Trials LLCVerified postcodeMontgomery, United States
- Mercy Gilbert Medical CenterVerified postcodeGilbert, United States
- Sun City Clinical ResearchVerified postcodeGlendale, United States
- Honor HealthVerified postcodeScottsdale, United States
- Clinical Research Institute of ArizonaVerified postcodeSurprise, United States
- National Heart Institute CalVerified postcodeBeverly Hills, United States
- California Inst Of Renal ResVerified postcodeChula Vista, United States
- Valley Clinical TrialsVerified postcodeCovina, United States
- First Valley Medical GroupVerified postcodeLancaster, United States
Common questions
What does 'atherosclerotic cardiovascular disease' mean?
It means you have a history of conditions like a heart attack, a stroke, or problems with blood flow in your legs due to narrowed or hardened arteries.
What is 'Placebo'?
A placebo is a dummy medicine that looks just like the real medicine but contains no active ingredients. It's used to fairly test if the new medicine works.
Will I know if I'm getting the real medicine or the placebo?
No, during the study, neither you nor the study team will know if you're receiving Zenagamtide or the placebo. This helps ensure fair results.
Is Zenagamtide available from my GP?
No, Zenagamtide is a new investigational medicine that is not yet approved or available for prescription by doctors outside of this research study.
How long will the study last?
The study is usually for a significant period, but the exact duration will be explained by the study team if you are considered eligible.
How to find out more
Novo Nordisk
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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