Active not recruitingPHASE3INTERVENTIONAL

A Study of Retatrutide (LY3437943) Compared to Tirzepatide (LY3298176) in Adults Who Have Obesity

This research study is comparing two experimental medications, Retatrutide and Tirzepatide, for adults who have obesity. The main goal is to find out if one medicine is more effective or safer than the other for helping people lose weight and keep it off. Researchers want to understand how these new treatments work and if they could be useful options for people struggling with obesity. The study will look closely at how participants respond to the medications over a period of about 89 weeks, checking for both positive effects and any potential side effects. It's a way to learn more about promising new treatments for weight management.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Eli Lilly and Company

Enrolment target

800

Start

01 Nov 2024

Estimated completion

01 Dec 2026

Obesity

What is this study about?

This clinical trial is an important step in understanding new ways to help adults living with obesity. It's comparing two medications, Retatrutide and Tirzepatide, to see how well they work and if they are safe. Both medications are being tested to see if they can help people lose weight effectively.

Obesity is a complex health condition that can lead to other health problems. Researchers are always looking for new and better treatments to help people manage their weight and improve their overall health. This study aims to gather detailed information on how these two specific drugs might help, providing valuable insights for future medical care.

The study will last for around 89 weeks, which is about a year and three-quarters. Throughout this time, participants will be carefully monitored. By comparing the two medications, doctors hope to learn which one offers the best balance of effectiveness and safety, ultimately helping more people achieve their health goals.

Key takeaways

The study compares two new drugs, Retatrutide and Tirzepatide, for obesity.
It aims to find out which drug is more effective and safer for weight loss.
Participation lasts about 89 weeks and involves regular clinic visits.
You must be an adult with obesity who has previously tried to lose weight.
Certain health conditions or recent medical events may prevent you from joining.
You can stop participating at any time without affecting your healthcare.

Who may be eligible?

To join this study, you must be an adult with obesity. You should also have tried to lose weight through diet before, but without success.

There are several reasons why someone might not be able to join. For example, if your weight has changed by more than 5 kilograms (about 11 pounds) in the three months before the study starts, or if you've had weight-loss surgery or procedures in the past or plan to have them. Also, if you've used weight-loss drugs (even over-the-counter ones) within three months of the study, you wouldn't be able to participate.

Certain health conditions would also prevent you from joining. These include a personal or family history of a specific type of thyroid cancer (medullary thyroid carcinoma) or a related condition (MEN-2). If you've had a heart attack, stroke, or heart-related hospitalisation in the past three months, or if you have severe heart failure or a history of pancreatitis, you would not be eligible.

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 an adult (18 years or older)?
Do you have obesity?
Have you tried losing weight through diet before, without success?
Have you avoided weight-loss drugs (including over-the-counter ones) for the past 3 months?
Do you have a personal or family history of certain types of thyroid cancer or related conditions?
Have you had a heart attack, stroke, or severe heart problems in the past 3 months, or do you have a history of pancreatitis?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive either Retatrutide or Tirzepatide medication. You won't know which one you're getting, as this is decided randomly to make the study fair. Participation will involve regular visits to a study clinic, where you'll have various health checks, assessments, and blood tests to monitor your progress and ensure your safety.

Throughout the study, you'll be giving information about your health, weight, and any side effects you might experience. The research team will guide you through all the steps and answer any questions you have. The total duration of your involvement in the study will be about 89 weeks, which is roughly a year and a three-quarters, including the time you take the medication and follow-up appointments.

Potential risks and benefits

Taking part in this study might offer potential benefits, such as receiving a potential new treatment for obesity and contributing to medical research that could help others. However, like all medications, the study drugs may have side effects, and some are not yet fully known. The research team will monitor you closely for any adverse effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care, if you decide it is no longer right for you.

Locations (65)

Medical Advancement Centers of Arizona
Verified postcode
Tempe, United States
Mary & Dick Allen Diabetes Center
Verified postcode
Newport Beach, United States
Artemis Institute for Clinical Research
Verified postcode
San Diego, United States
Encompass Clinical Research
Verified postcode
Spring Valley, United States
Diablo Clinical Research, Inc.
Verified postcode
Walnut Creek, United States
Lynn Institute of Denver
Verified postcode
Aurora, United States
Bridgeport Hospital
Verified postcode
Bridgeport, United States
Yale University School of Medicine
Verified postcode
New Haven, United States
Encore Medical Research
Verified postcode
Hollywood, United States
Suncoast Research Group
Verified postcode
Miami, United States
Onhealth Research Center
Verified postcode
Miami, United States
Precision Clinical Research
Verified postcode
Sunrise, United States

Common questions

What is obesity?

Obesity is a medical condition where someone has too much body fat, which can negatively affect their health. It's often measured using something called Body Mass Index (BMI).

What are Retatrutide and Tirzepatide?

These are both experimental medications being tested to see if they can help people with obesity lose weight. They are not yet widely available as treatments.

How long will the study last?

Your involvement in the study will last for approximately 89 weeks, which is about one year and three-quarters.

Will I know which medication I'm taking?

No, participants in this type of study usually don't know which medication they are receiving until the study is over. This helps ensure fair results.

Can I stop participating in the study if I want to?

Yes, you have the right to withdraw from the study at any time, for any reason, and it won't affect your medical care.