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RecruitingPHASE3INTERVENTIONAL

A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight and Chronic Low Back Pain

This research study is investigating a new medicine called retatrutide. It's for adults who are either overweight or have obesity and are experiencing ongoing (chronic) lower back pain. The main goals are to find out if retatrutide can effectively reduce their lower back pain and if it is safe for them. Some people in the study will receive retatrutide, while others will receive a placebo, which looks like the study medicine but has no active ingredient. This helps researchers compare the effects accurately. The study will last for about 80 weeks, which is roughly a year and a half.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
Eli Lilly and Company
Enrolment target
586
Start
29 May 2025
Estimated completion
01 Sep 2027

What is this study about?

This study is exploring a new treatment called retatrutide for a common problem: long-lasting lower back pain in people who are overweight or have obesity. Many people experience lower back pain, and for some, managing their weight is also a challenge. Researchers want to understand if there's a link between these two conditions and if this new medicine could offer a solution.

During the study, some participants will receive the active medicine, retatrutide, and others will receive a placebo. A placebo is a dummy treatment that looks exactly like the real medicine but contains no active ingredients. This is a standard and important part of clinical trials. It allows the researchers to accurately compare how well the new medicine works against not receiving the active drug, helping them determine the true effect of retatrutide.

The findings from this study could be very important. If retatrutide proves to be both effective and safe, it could offer a new treatment option for people living with both obesity or overweight and chronic lower back pain. This could potentially improve their quality of life and reduce their discomfort.

Key takeaways

  • This study is testing a new medicine for lower back pain in people who are overweight or have obesity.
  • Half of the participants will receive the active medicine, and half will receive a placebo.
  • The study aims to see if the medicine is effective and safe.
  • Participation involves regular clinic visits and lasts about 80 weeks.
  • You must have ongoing lower back pain and a BMI of 27 or higher to be considered.
  • People with any type of diabetes cannot participate.

Who may be eligible?

This study is looking for adults aged 18 and over who have ongoing lower back pain that mostly affects their lower spine. Your pain should be mainly in your lower back or spread slightly to your upper legs. You also need to have a body mass index (BMI) of 27 or higher, which indicates you are overweight or have obesity. You should also have tried to lose weight through diet at least once before without success.

There are some reasons why you might not be able to join. For example, if your back pain isn't clearly from your lower spine, or if you've had certain injections into your spine (like Botox or steroids within the last year, or trigger point injections within six months). If your weight has changed by more than 5 kilograms (11 pounds) in the last 90 days, or if you've used medicines for weight loss recently, you would also not be able to take part. The study also cannot include people who have had weight-loss surgery or have any type of diabetes.

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 ongoing lower back pain that mainly affects your lower spine?
  3. Is your pain limited to your lower back or only slightly radiates down your upper legs?
  4. Is your Body Mass Index (BMI) 27 or higher?
  5. Have you tried to lose weight through diet at least once before without success?
  6. Do you have any type of diabetes? (If yes, you likely can't join)
Answer every question to see your result.

What does participation involve?

If you decide to take part, your involvement in the study will last for roughly 80 weeks, which is about a year and a half. During this time, you'll have several visits to the study clinic for assessments. These will likely include check-ups, questionnaires about your pain and overall health, and possibly blood tests. You will be given either the study medicine (retatrutide) or a placebo, and you'll need to take it as instructed. There will be regular follow-up appointments to monitor your progress and make sure you're doing well. The healthcare team will explain all the details of what each visit involves and how often you'll need to attend.

Potential risks and benefits

Like all clinical trials, there might be potential benefits to taking part in this study. You could receive a new medicine that might help relieve your lower back pain and support weight management, and you'll receive careful medical supervision throughout. However, there are also potential risks, such as side effects from the medicine, which will be fully explained to you. It's also possible that the medicine may not work for you. Remember, joining a clinical trial is always voluntary, and you have the right to withdraw at any time without affecting your usual medical care.

Locations (40)

  • MD First Research - Chandler
    Verified postcode
    Chandler, United States· Recruiting
  • Tucson Orthopaedic Institute - North Wyatt Drive
    Verified postcode
    Tucson, United States· Recruiting
  • Ark Clinical Research - Fountain Valley
    Verified postcode
    Fountain Valley, United States· Recruiting
  • St Joseph Heritage Healthcare
    Verified postcode
    Fullerton, United States· Recruiting
  • Clinical Research Institute
    Verified postcode
    Los Angeles, United States· Recruiting
  • Artemis Institute for Clinical Research
    Verified postcode
    San Diego, United States· Recruiting
  • Alpine Clinical Research Center
    Verified postcode
    Boulder, United States· Recruiting
  • K2 Medical Research - Daytona Beach
    Verified postcode
    Daytona Beach, United States· Recruiting
  • Flourish Research - Miami, LLC
    Verified postcode
    Miami, United States· Recruiting
  • IMA Clinical Research St. Petersburg
    Verified postcode
    St. Petersburg, United States· Recruiting
  • Care Access - Tampa
    Verified postcode
    Tampa, United States· Recruiting
  • Charter Research - Lady Lake
    Verified postcode
    The Villages, United States· Recruiting

Common questions

What is retatrutide?

Retatrutide is a new medicine being studied to see if it can help people who are overweight or have obesity and suffer from chronic lower back pain.

What is a placebo?

A placebo is a 'dummy' treatment that looks just like the study medicine but doesn't contain any active ingredients. It helps researchers compare the real medicine's effects accurately.

How long does the study last?

The study lasts for about 80 weeks, which is roughly one and a half years.

Can I join if I have diabetes?

No, if you have any type of diabetes (Type 1 or Type 2), you would not be able to join this particular study.

What if I decide I don't want to continue?

You are free to leave the study at any time, for any reason, without it affecting your regular medical care.

How to find out more

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "A Study of Retatrutide (LY3437943) in Participants Who Have …" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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