All studies
Active not recruitingPHASE3INTERVENTIONAL

A Study of Retatrutide (LY3437943) in Participants With Obesity or Overweight

This research study is investigating a new medication, retatrutide, for individuals who are overweight or have obesity. The main goal is to find out if this medication is effective in helping people lose weight and if it is safe to use. Participants will either receive retatrutide or a placebo (a dummy treatment with no active drug) to compare the effects. The study will last for about 65 weeks, during which participants would attend around 18 visits to the clinic. This research is important for finding potential new treatments to help manage weight.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
Eli Lilly and Company
Enrolment target
250
Start
17 Nov 2025
Estimated completion
01 Jul 2027

What is this study about?

This study is looking into a new medication called retatrutide, for people who are struggling with their weight. It's being tested to see if it can help individuals who are overweight or have obesity to lose weight effectively and safely. Scientists are comparing this new medication to a 'placebo', which is a dummy treatment that looks just like the real medication but doesn't contain any active drug. This allows them to clearly see what effects, if any, the new medication has.

Obesity and being overweight can lead to various health problems, so finding safe and effective ways to help people manage their weight is very important. This study is in 'Phase 3', which means it's one of the final stages of testing before a new medication might become widely available. It involves a larger group of people to gather more information on its benefits and potential side effects.

The information gathered from this study will help doctors and researchers understand if retatrutide could be a valuable new option for weight management. We hope the findings will contribute to better ways of supporting people to achieve a healthier weight.

Key takeaways

  • This study is testing a new weight loss medication called retatrutide.
  • It aims to check how well the medication works and if it's safe.
  • Participants will receive either the study drug or a placebo (dummy treatment).
  • The study lasts about 65 weeks and involves around 18 clinic visits.
  • It's for adults who are overweight or have obesity and have tried dieting without success.
  • Participation is voluntary, and you can leave the study at any time.

Who may be eligible?

To be considered for this study, you would generally need to be an adult (18 years or older) and meet certain criteria related to your weight. This often means having a Body Mass Index (BMI) of 30 or higher, which is generally considered obesity. Alternatively, if your BMI is 27 or higher (which is considered overweight), you might still be eligible if you also have at least one weight-related health condition, such as high blood pressure, unhealthy cholesterol levels, sleep apnea, or heart disease. You also need to have tried to lose weight through dieting in the past without success.

There are also some reasons why you wouldn't be able to join the study. For example, if your weight has changed by more than 5 kg (about 11 pounds) in the last 3 months, or if you've had surgery for weight loss or plan to have one. People with certain health conditions, like Type 1 or Type 2 diabetes, certain thyroid cancers (called MTC or MEN-2), or serious heart problems like a recent heart attack or stroke, wouldn't be able to take part. Also, if you've had problems with your pancreas (like pancreatitis) or have taken other weight loss medications (even over-the-counter ones) in the last 3 months, you wouldn't 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.

  1. Are you 18 years old or older?
  2. Do you have a BMI of 30 or higher, or a BMI of 27 or higher with a weight-related health issue (like high blood pressure or unhealthy cholesterol)?
  3. Have you tried to lose weight by dieting in the past without success?
  4. Have you *not* had any weight loss surgery or plan to have one?
  5. Do you *not* have Type 1 or Type 2 diabetes?
  6. Have you *not* taken other weight loss medications in the last 3 months?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be involved for about 65 weeks, which is roughly 15 months. Over this time, you would attend about 18 appointments at the study clinic. During these visits, the study team would monitor your health, take various measurements, and you would receive either the study medication (retatrutide) or the placebo. You wouldn't know which one you are receiving. The study team will provide all the necessary medication and instructions. Throughout the study, your health and progress will be carefully checked. There will also be a follow-up period to ensure your safety and monitor your health after the main treatment phase.

Potential risks and benefits

Participating in a clinical study can offer potential benefits, such as contributing to medical knowledge and potentially receiving a new treatment that might help with weight loss, free of charge. However, there are also potential risks, including side effects from the medication (which are carefully monitored), and some inconvenience due to the number of clinic visits. It's important to remember that you might receive the placebo, which means you wouldn't get the active drug. Your decision to take part is entirely voluntary, and you have the right to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (31)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Artemis Institute for Clinical Research
    Verified postcode
    Riverside, United States
  • JEM Research Institute
    Verified postcode
    Atlantis, United States
  • Headlands Research Orlando
    Verified postcode
    Orlando, United States
  • Care Access - Tamarac
    Verified postcode
    Tamarac, United States
  • Care Access - Arlington Heights
    Verified postcode
    Arlington Heights, United States
  • L-MARC Research Center
    Verified postcode
    Louisville, United States
  • IMA Clinical Research Monroe - Armand
    Verified postcode
    Monroe, United States
  • Pharmasite Research, Inc.
    Verified postcode
    Baltimore, United States
  • Clinical Research Professionals
    Verified postcode
    Chesterfield, United States
  • Clinvest Headlands Llc
    Verified postcode
    Springfield, United States
  • IMA Clinical Research Warren
    Verified postcode
    Warren Township, United States
  • IMA Clinical Research Manhattan
    Verified postcode
    New York, United States

Common questions

What is retatrutide?

Retatrutide is a new medication being studied to see if it can help people who are overweight or have obesity to lose weight.

What is a 'placebo'?

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

How long will the study last?

If you join, your participation in the study will last for about 65 weeks, which is roughly 15 months.

How many times will I need to visit the clinic?

You can expect to have about 18 visits to the clinic throughout the study period.

Can I leave the study if I change my mind?

Yes, your participation is voluntary, and you can withdraw from the study at any time without any reason and 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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