A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease (ATTAIN-Outcomes)
The ATTAIN-Outcomes study is investigating a new medicine, orforglipron, for its effects on heart health. It's for adults who already have heart disease (atherosclerotic cardiovascular disease) and/or long-term kidney problems (chronic kidney disease). Researchers want to see if orforglipron can help prevent serious heart-related issues compared to a dummy medicine, called a placebo. This is a "Phase 3" study, meaning it's a large trial to confirm the medicine's safety and effectiveness. Participants will be involved for approximately five years. The goal is to understand if this new treatment could be a helpful option for people managing these conditions.
At a glance
What is this study about?
This study, called ATTAIN-Outcomes, is looking into a new medication named orforglipron. It's designed for people who have certain heart conditions, specifically atherosclerotic cardiovascular disease, which means a build-up of fatty deposits in the arteries. It's also for those with long-term kidney problems, known as chronic kidney disease. We know that these conditions can sometimes make other health problems more likely, especially affecting the heart.
The main aim of this study is to find out if orforglipron can help improve heart health outcomes for these patients. This means we want to see if it can lower the chances of things like heart attacks, strokes, or other heart-related issues. To do this, some participants will receive orforglipron, and others will receive a 'placebo', which looks like the medication but doesn't contain any active drug. This allows researchers to compare the two groups and understand the true effects of the new medicine.
By taking part, you would be helping doctors and scientists learn more about how to best treat and support people living with heart and kidney conditions. The information gathered from this study could lead to new ways to improve care for many people in the future.
Key takeaways
- This study is testing a new medicine, orforglipron, for heart and kidney conditions.
- It aims to see if the medicine can improve heart health outcomes.
- The study includes adults with existing heart disease or chronic kidney disease, usually aged 50 and above.
- Some participants will get the new medicine, others a dummy pill (placebo).
- Participation lasts about five years with regular check-ups.
- You can always choose to stop being part of the study at any time.
Who may be eligible?
To join this study, you must already have a diagnosis of either heart disease where arteries are narrowed (atherosclerotic cardiovascular disease) or long-term kidney disease (chronic kidney disease).
There are also some important reasons why you might not be able to join. For example, if you have Type 1 diabetes, you would not be eligible. Also, if you've had a significant heart event, like a heart attack or stroke, within the last two months, you wouldn't be able to participate right now. Finally, if you have a very severe form of heart failure, known as Class IV, you would also not be able to join this particular study.
The study is open to both men and women, usually aged 50 years and older. Your study doctor will check all these details carefully to make sure the study is right and safe 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.
- Do I have a diagnosis of atherosclerotic cardiovascular disease?
- Do I have a diagnosis of chronic kidney disease?
- Am I aged 50 or older?
- Do I have Type 1 diabetes (if yes, you likely can't join)?
- Have I had a major heart problem in the last two months (if yes, you likely can't join)?
- Do I have very severe heart failure (NYHA Class IV - if yes, you likely can't join)?
What does participation involve?
If you decide to take part, your involvement in the study will last for about five years. During this time, you will have regular visits to the clinic where the study team will monitor your health closely. These visits will involve various tests and checks to see how you are doing and how the medicine is affecting you. You will be given either the study medicine, orforglipron, or a placebo to take regularly throughout the study period, following instructions from the study team. You'll also have follow-up appointments to track your progress and any changes in your health. The study team will explain everything in detail if you are interested.
Potential risks and benefits
Locations (568)
- Instituto de Investigaciones Clínicas Bahia BlancaVerified postcodeBahía Blanca, Argentina· Recruiting
- CONEXA Investigacion Clinica S.A.Verified postcodeBuenos Aires, Argentina· Recruiting
- Buenos Aires Macula S.AVerified postcodeBuenos Aires, Argentina· Recruiting
- CIPRECVerified postcodeBuenos Aires, Argentina· Recruiting
- Instituto Médico Especializado (IME)Verified postcodeBuenos Aires, Argentina· Recruiting
- Cicemo SrlVerified postcodeBuenos Aires, Argentina· Recruiting
- Cardiología PalermoVerified postcodeBuenos Aires, Argentina· Recruiting
- Consultorio Medico Investigador Principal Dr BesadaVerified postcodeBuenos Aires, Argentina· Recruiting
- Glenny Corp. S.A.Verified postcodeBuenos Aires, Argentina· Recruiting
- Organizacion Medica de InvestigacionVerified postcodeBuenos Aires, Argentina· Recruiting
- Stat Research S.A.Verified postcodeBuenos Aires, Argentina· Recruiting
- Investigaciones Medicas Imoba SrlVerified postcodeBuenos Aires, Argentina· Recruiting
Common questions
What is 'atherosclerotic cardiovascular disease'?
It's a common type of heart disease where fatty deposits build up inside your arteries, making them narrower and harder, which can affect blood flow to your heart or other parts of your body.
What is 'chronic kidney disease'?
This means your kidneys aren't working as well as they should to filter waste from your blood, and this has been going on for a long time.
What is a 'placebo'?
A placebo is a dummy medicine that looks exactly like the real study drug but doesn't contain any active ingredients. It helps researchers compare the effects of the new medicine.
How long will I be in the study?
If you join, your participation in the study will last for approximately five years.
Can I leave the study if I change my mind?
Yes, absolutely. You can withdraw from the study at any time, for any reason, without it affecting your medical care.
How to find out more
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.