All studies
Active not recruitingPHASE3INTERVENTIONAL

The Effect of Retatrutide Once Weekly on Cardiovascular Outcomes and Kidney Outcomes in Adults Living With Obesity (TRIUMPH-Outcomes)

This research, called TRIUMPH-Outcomes, is testing a new medicine called retatrutide. The main goal is to find out if this weekly injection can significantly lower the chances of serious heart problems or prevent kidney disease from worsening in adults. Participants must have a body mass index (BMI) of 27 or higher, and already have heart disease or chronic kidney disease. This is a large-scale study, expected to last about five years. During this time, participants will have regular check-ups with the study doctors to monitor their health and the effects of the treatment.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
Eli Lilly and Company
Enrolment target
10,000
Start
30 Apr 2024
Estimated completion
01 Feb 2029

What is this study about?

This study is investigating a new medicine called retatrutide. Researchers want to understand if this medicine can help protect the heart and kidneys in people who are living with obesity and already have existing heart or kidney conditions. Heart disease, like heart attacks or strokes, and chronic kidney disease are serious health challenges, and finding new ways to manage them is very important.

The main idea behind this study is to see if retatrutide can reduce the risk of future serious heart problems or stop kidney problems from getting worse. It's hoped that by carefully studying this new medicine, we can learn more about how to improve the health and well-being of people facing these conditions. The study will compare retatrutide to a 'placebo', which is a dummy medicine, to properly understand its effects.

Taking part in a study like this helps doctors and researchers learn more about new treatments. This knowledge can then benefit many other people in the future. It's a key step in developing new therapies to tackle important health issues affecting many people in the UK and worldwide.

Key takeaways

  • Tests a new medicine, retatrutide, for heart and kidney health.
  • For adults with obesity, heart disease, or kidney problems.
  • Compares retatrutide to a placebo (dummy medicine).
  • Study lasts about 5 years with regular clinic visits.
  • Aims to reduce serious heart issues and slow kidney disease.
  • You can withdraw from the study at any time.

Who may be eligible?

To join this study, you need to be an adult of any age from 45 years upwards, and have a Body Mass Index (BMI) of 27 or higher. You must also have existing heart disease (like problems with your heart arteries, a history of stroke, or poor circulation in your legs) or certain levels of chronic kidney disease. If you have type 2 diabetes, your blood sugar levels (HbA1c) need to be 10% or less.

There are also reasons why you might not be able to join. For instance, if you have type 1 diabetes or have recently had a heart attack, stroke, or certain heart or circulation procedures in the last three months. You also can't take part if you have severe heart failure, very advanced kidney disease, are on dialysis, or have had a kidney transplant. Certain other conditions, like a history of pancreatitis, some types of thyroid cancer, or previous weight-loss surgery, would also prevent you from joining.

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 an adult aged 45 or older?
  2. Do you have a Body Mass Index (BMI) of 27 or higher?
  3. Have you been diagnosed with heart disease OR chronic kidney disease?
  4. Have you NOT had a heart attack, stroke, or certain heart procedures in the last 3 months?
  5. Are you NOT currently on dialysis or do you not have very severe kidney disease?
  6. Do you NOT have Type 1 Diabetes or very severe heart failure?
Answer every question to see your result.

What does participation involve?

If you join this study, you'll be part of it for about five years. During this time, you will have up to 27 visits with the study doctor at the clinic. These visits are important for the team to monitor your health, give you the study medicine (either retatrutide or a placebo), and perform any necessary tests. They will also check how you are feeling and if you are experiencing any side effects. The medicine will likely be given as a once-weekly injection. You will be closely supported by the study team throughout your involvement.

Potential risks and benefits

Participating in a clinical trial offers potential benefits, such as receiving a new investigational treatment and close medical monitoring. You might also contribute to medical knowledge that could help others in the future. However, there are also potential risks; the new medicine might cause side effects, or it might not work for you. Some tests in the study could also rarely have minor risks. You will be told about all known risks before you decide to join. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (745)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Alabama Kidney Research
    Verified postcode
    Alabaster, United States
  • Central Research Associates
    Verified postcode
    Birmingham, United States
  • Alliance for Multispecialty Research, LLC
    Verified postcode
    Daphne, United States
  • Nephrology Consultants
    Verified postcode
    Huntsville, United States
  • Alliance for Multispecialty Research, LLC
    Verified postcode
    Mobile, United States
  • Prime Medical Group, LLC dba Gilbert Center for Family Medicine, LLC
    Verified postcode
    Gilbert, United States
  • Sun City Clinical Research
    Verified postcode
    Glendale, United States
  • Arizona Kidney Disease & Hypertension Center (AKDHC) - Thunderbird
    Verified postcode
    Glendale, United States
  • Helios Clinical Research - SAZ-PDV-026
    Verified postcode
    Paradise Valley, United States
  • Banner University Medical Center Phoenix
    Verified postcode
    Phoenix, United States
  • Phoenix Clinical LLC
    Verified postcode
    Phoenix, United States
  • Elite Clinical Studies, LLC
    Verified postcode
    Phoenix, United States

Common questions

What is retatrutide?

Retatrutide is a new medicine being studied to see if it can help people with obesity, heart disease, or kidney problems.

What is a placebo?

A placebo is a 'dummy' medicine that looks like the real treatment but doesn't contain any active drug. It helps researchers compare the effects of the new medicine.

How long will the study last?

The study is expected to last for about five years.

How often will I need to visit the clinic?

You'll have up to 27 clinic visits with the study doctor over the five years.

Can I stop participating if I want to?

Yes, you have the right to withdraw from the study at any time, for any reason, without affecting your 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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