All studies
Active not recruitingPHASE3INTERVENTIONAL

A Study of Retatrutide (LY3437943) in the Maintenance of Weight Reduction in Individuals With Obesity

This research is looking into a new drug, Retatrutide, for individuals who are overweight. The main goal is to understand how well Retatrutide can help people keep off weight they've lost. The study involves two parts: an initial 80-week phase where everyone takes Retatrutide, followed by a 36-week phase where participants are randomly assigned to either continue with Retatrutide, try a different dose, or switch to a dummy medication (placebo). Taking part in the study will last for about 125 weeks in total.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
Eli Lilly and Company
Enrolment target
643
Start
05 Mar 2025
Estimated completion
01 Apr 2028

What is this study about?

This clinical trial is designed for people who are living with obesity and have tried to lose weight before without long-term success. The study is particularly interested in a new medication called Retatrutide. Researchers want to find out if this medication can help people not just lose weight, but importantly, to maintain that weight loss over time.

The study is set up in a way that allows researchers to carefully compare the effects of Retatrutide against a placebo. A placebo is a treatment that looks like the study drug but doesn't contain any active medication. This helps scientists to be sure any changes observed are due to the Retatrutide itself and not other factors, like the expectation of receiving treatment. This type of research is vital for understanding how new medications work and if they can be a safe and effective option for people in the future.

By taking part, you would be contributing to our understanding of obesity and potential new treatments. This kind of research helps improve healthcare options for many people. It's important to remember that participating in a clinical trial means you are helping science, and there's no guarantee of personal benefit, though any potential benefits and risks will be thoroughly explained.

Key takeaways

  • Exploring a new medication (Retatrutide) for maintaining weight loss in obesity.
  • Study duration is around 125 weeks (about 2.5 years).
  • Involves an initial phase with Retatrutide, followed by a comparison to placebo or different dose.
  • Careful eligibility checks to ensure participant safety.
  • Participation contributes to scientific understanding of obesity treatments.
  • You can withdraw from the study at any time.

Who may be eligible?

To join this study, you must be an adult aged 18 or older and be living with obesity. You should also have tried to lose weight through diet at least once before, without lasting success.

There are several reasons why you might not be able to participate. For example, if your weight has changed by more than 5 kilograms (about 11 pounds) in the 90 days before the study starts, or if you've already had or are planning to have weight-loss surgery or certain other procedures for obesity, you wouldn't be eligible. Also, if you have types 1 or 2 diabetes, or certain heart conditions, you wouldn't be able to join. Your doctor will carefully check your medical history to ensure your safety and suitability for the study.

Additionally, if you have a family history of medullary thyroid cancer or certain related genetic conditions, or if you've had specific serious heart problems or inflammation of the pancreas recently, you wouldn't be able to take part. This also applies if you've used any weight-loss medications, even over-the-counter ones, within the 90 days before screening.

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 obesity?
  3. Have you tried to lose weight by dieting before?
  4. Have you avoided weight loss surgeries or certain related procedures?
  5. Do you not have Type 1 or Type 2 diabetes?
  6. Have you avoided taking other weight loss drugs in the last 90 days?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be involved in the study for approximately 125 weeks, which is about two and a half years. The study has two main treatment phases. For the first 80 weeks, everyone receives the same dose of Retatrutide. After this initial period, you'll be randomly assigned to one of three groups for the next 36 weeks: either you'll continue with the same dose of Retatrutide, switch to a different dose, or receive a placebo (a dummy treatment without any active medication). This assignment is 'double-blinded', meaning neither you nor your study doctor will know which group you are in. Throughout the study, you will have regular visits to the clinic for health checks, assessments, and to receive your medication. The research team will explain all the visits and procedures in detail before you agree to participate.

Potential risks and benefits

Participating in this trial might offer potential benefits, such as close medical monitoring and access to a new medication that could help with weight management. However, there's no guarantee that Retatrutide will work for you, or that you'll be in the group receiving active medication during the second phase. Like all medications, Retatrutide may have side effects, and these would be fully explained to you by the study team. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (53)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Southern California Clinical Research
    Verified postcode
    Santa Ana, United States
  • University of Colorado Anschutz Medical Campus
    Verified postcode
    Aurora, United States
  • CMR of Greater New Haven, LLC
    Verified postcode
    Hamden, United States
  • ALL Medical Research, LLC
    Verified postcode
    Cooper City, United States
  • Florida International Medical Research
    Verified postcode
    Coral Gables, United States
  • Renstar Medical Research
    Verified postcode
    Ocala, United States
  • Charter Research - Winter Park
    Verified postcode
    Orlando, United States
  • Metabolic Research Institute, Inc.
    Verified postcode
    West Palm Beach, United States
  • Kubost Clinical Research - Marietta
    Verified postcode
    Marietta, United States
  • North Georgia Clinical Research
    Verified postcode
    Woodstock, United States
  • Pacific Diabetes & Endocrine Center
    Verified postcode
    Honolulu, United States
  • Alliance for Multispecialty Research, LLC
    Verified postcode
    Oak Brook, United States

Common questions

What is Retatrutide?

Retatrutide is a new investigational medication that is being studied for its potential in managing obesity and helping people maintain weight loss.

What is a placebo?

A placebo is a 'dummy' treatment that looks just like the study medication but does not contain any active drug. It helps researchers understand if the study medication is truly effective.

How long will I be in the study?

Participation in the study will last for approximately 125 weeks, which is about two and a half years.

Can I leave the study at any time?

Yes, you have the right to withdraw from the study at any point, for any reason, without affecting your medical care.

What does 'double-blinded' mean?

Double-blinded means that neither you nor your study doctor will know whether you are receiving the active medication or the placebo during part of the study. This helps ensure unbiased results.

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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