All studies
Active not recruitingPHASE3INTERVENTIONAL

A Study of Retatrutide (LY3437943) in Participants With Obesity and Cardiovascular Disease

This research study is testing a new medicine called retatrutide, given once a week, for people who have both obesity and existing heart and blood vessel problems. The main goal is to find out if retatrutide is effective at helping with weight loss and if it's safe to use. Heart and blood vessel problems, also known as cardiovascular disease, include conditions like having had a heart attack, stroke, or circulation issues in the legs. Participants in the study will either receive retatrutide or a placebo (a dummy drug with no active ingredients). The study is expected to last for about two years. By understanding more about this new treatment, doctors hope to find better ways to help people manage their weight and improve their heart health.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
Eli Lilly and Company
Enrolment target
1,946
Start
30 May 2023
Estimated completion
01 May 2026

What is this study about?

This is a research study looking into a new medicine called retatrutide. The main aim is to see if this medicine, taken once a week, can help people who are living with both obesity and heart and blood vessel problems. These kinds of heart problems are sometimes called 'cardiovascular disease' and could include things like having had a heart attack or a stroke in the past, or problems with circulation in your legs.

Doctors want to understand two key things about retatrutide: first, if it actually works to help people lose weight, and second, if it's safe to use. You might be given the new medicine or a 'placebo', which looks exactly like the medicine but doesn't have any active ingredients. This helps researchers understand if any changes are truly due to the new medicine or not.

Finding new and effective ways to help people manage their weight and improve their heart health is very important. This study could help us learn more about potential new treatments and how they might benefit people in the future.

Key takeaways

  • This study is testing a new weekly medicine, retatrutide, for obesity and heart disease.
  • It aims to see if retatrutide is safe and helps with weight loss compared to a dummy medicine.
  • The study will last about two years with regular clinic visits.
  • You might receive the new medicine or a placebo (inactive treatment).
  • Participation includes close medical monitoring and potential benefits or risks.
  • You can stop participating at any time you wish.

Who may be eligible?

To join this study, you would need to be 18 years old or older and have a Body Mass Index (BMI) of 35 or above, which is a measure that indicates obesity. You would also need to have a history of heart or blood vessel disease, such as having had a heart attack, stroke, or a condition affecting the blood flow to your legs. Additionally, you should have tried to lose weight through dieting at least once before, without success.

There are also some reasons why you might not be able to join. For example, if you've recently had a serious heart event, like a heart attack or stroke, within the last three months, or if you've had major heart surgery during that time. You also couldn't join if you've taken weight-loss medicines (even some over-the-counter ones) in the last three months, or if you've had major weight-loss surgery or have plans to have one. Significant weight changes (more than 5 kg or about 11 pounds) in the last three months would also make you ineligible. People with Type 1 diabetes, a personal or family history of a specific type of thyroid cancer (medullary thyroid carcinoma or MEN-2), or a history of pancreatitis would also not be able to participate.

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.

  1. Are you 18 years old or older?
  2. Do you have a BMI of 35 or higher (indicating obesity)?
  3. Have you had a heart attack, stroke, or circulation problems in your legs?
  4. Have you tried to lose weight with diet before, but it didn't work?
  5. Have you *not* had a recent heart attack, stroke, or major heart surgery in the last 3 months?
  6. Are you *not* currently taking weight-loss medication or planning weight-loss surgery?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it would last for about two years (113 weeks). You would have regular visits to the clinic where you would have various assessments. This would likely include physical examinations, blood tests, and other checks to monitor your health and how the study medicine is affecting you. You would be given either the new medicine (retatrutide) or a placebo (a dummy medicine) to take once a week. The research team would explain exactly how and when to take your study medicine. After the main treatment period, there will be a follow-up period to ensure your continued well-being. All study-related care and medicines would be provided at no cost, and you would be fully supported throughout the process.

Potential risks and benefits

Taking part in a study like this might offer some potential benefits, such as receiving a new medicine that could help with your weight and heart health, as well as close medical monitoring and care from a research team. However, there are also potential risks, such as side effects from the study medicine, which would be explained in detail. You might also receive the placebo and not the active medicine. It's very important to remember that you are free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (169)

  • Central Phoenix Medical Clinic
    Verified postcode
    Phoenix, United States
  • Valley Clinical Trials, Inc.
    Verified postcode
    Covina, United States
  • Neuro-Pain Medical Center
    Verified postcode
    Fresno, United States
  • Valley Research
    Verified postcode
    Fresno, United States
  • Collaborative Neuroscience Research, LLC
    Verified postcode
    Los Alamitos, United States
  • Velocity Clinical Research, Westlake
    Verified postcode
    Los Angeles, United States
  • Valley Clinical Trials, Inc.
    Verified postcode
    Northridge, United States
  • Velocity Clinical Research, Panorama City
    Verified postcode
    Van Nuys, United States
  • Chase Medical Research, LLC
    Verified postcode
    Waterbury, United States
  • Indago Research & Health Center, Inc
    Verified postcode
    Hialeah, United States
  • Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
    Verified postcode
    Jacksonville, United States
  • Clinical Neuroscience Solutions, Inc.
    Verified postcode
    Orlando, United States

Common questions

What is retatrutide?

Retatrutide is a new medicine being tested in this study to see if it can help people with obesity and heart problems to lose weight and improve their health.

What is a placebo?

A placebo is a 'dummy' medicine that looks like the real medicine but contains no active ingredients. It helps researchers see if any effects are truly from the new medicine.

How long will the study last?

The study is expected to last for about 113 weeks, which is just over two years.

Will I know if I'm getting the real medicine or the placebo?

No, neither you nor the study team will know who is getting the active medicine and who is getting the placebo. This helps make the study results as fair and accurate as possible.

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 future 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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