A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight and Chronic Low… (NCT07035093) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight and Chronic Low Back Pain
United States, Argentina, Canada586 participantsStarted 2025-05-29
Plain-language summary
The main purpose of this study is to evaluate the efficacy and safety of retatrutide in relieving chronic low back pain in participants who have obesity or overweight. Participation in the study will last about 80 weeks.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Have a history of axial-predominant low back pain
* Have pain that is restricted to the low back or with a referral pattern limited to the proximal legs
* Have a body mass index (BMI) ≥27 kilograms per square meter (kg/m2) at screening
* Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight
Exclusion Criteria:
* Have a non-axial origin low back pain
* Have had botulinum or steroid injections to the spine within 1 year of screening
* Have had trigger point injection to the spine within 6 months of screening
* Have a self-reported change in body weight \>5 kilograms (kg) (11 pounds) within 90 days prior to screening
* Have been taking drugs to promote body weight reduction, including over-the-counter medications, within 90 days prior to screening
* Have a prior or planned surgical treatment for obesity
* Have Type 1 Diabetes, Type 2 Diabetes, or any other type of diabetes
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 3 trial testing retatrutide for both obesity and chronic low back pain together — is there evidence from earlier phases that this drug actually helps with back pain specifically, or is that still being explored in this study?
2The trial is measuring both pain intensity on a numeric rating scale and body weight change — does that mean we'd be tracking two separate goals, and how would my doctor know if the drug is working for my back pain versus just my weight?
3Since this trial is actively recruiting right now, what would my day-to-day commitment look like in terms of visits, injections, or check-ins, and is that realistic given my current pain levels and mobility?
4Before considering this trial, should I try standard treatments for chronic low back pain — like physical therapy, existing medications, or weight-loss programs — or is there a reason it might make sense to discuss this study as an option sooner?
5If I enroll and am assigned to a placebo or a lower dose, what happens to my chronic low back pain management during the study, and would I still have access to my usual pain treatments?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from Baseline in Pain Intensity Per Numeric Rating Scale