Retatrutide for people with overweight or obesity and chronic low back pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3, randomized interventional trial compares retatrutide against placebo in adults with axial-predominant chronic low back pain and a body mass index of at least 27 kg/m2. Participants will be followed for about 80 weeks to monitor changes in pain, safety, and other outcomes such as weight. Key eligibility excludes people with diabetes, non-axial sources of back pain, recent spine injections, recent large weight changes, or recent use of weight-loss drugs. The sponsor is Eli Lilly and Company and the investigational drug has previously been studied for weight loss, with pain outcomes being a primary focus here.

Why it matters

Who can join: the full rules

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

Where it's running

• MD First Research - Chandler
  Chandler, Arizona, United States Recruiting
• Tucson Orthopaedic Institute - North Wyatt Drive
  Tucson, Arizona, United States Recruiting
• Ark Clinical Research - Fountain Valley
  Fountain Valley, California, United States Recruiting
• St Joseph Heritage Healthcare
  Fullerton, California, United States Recruiting
• Clinical Research Institute
  Los Angeles, California, United States Recruiting
• Artemis Institute for Clinical Research
  San Diego, California, United States Recruiting

Study contacts

• Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
• Email: LillyTrials@Lilly.com
• Phone: 1-317-615-4559

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.