Retatrutide for Chronic Low Back Pain

(TRIUMPH-7 Trial)

Recruiting at 54 trial locations

Overseen By Physicians interested in becoming principal investigators please contact

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Eli Lilly and Company

Must not be taking: Weight loss drugs

Disqualifiers: Non-axial pain, Diabetes, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 76 weeks

586 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called retatrutide to determine its effectiveness in relieving chronic low back pain in individuals who are overweight or have obesity. Researchers aim to assess whether this treatment is both effective and safe for managing this type of pain. Participants will receive either retatrutide or a placebo (a dummy treatment) for about 80 weeks. It suits individuals with chronic low back pain primarily in the lower back or upper legs, who have tried but struggled to lose weight through dieting. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have taken weight loss drugs in the 90 days before screening.

Is there any evidence suggesting that retatrutide is likely to be safe for humans?

Research has shown that retatrutide, a treatment under study for chronic low back pain, has been safe in previous trials. It was tested in adults with obesity, resulting in weight loss and improved health. Safety results from these studies suggest that retatrutide is generally well-tolerated. Although every treatment can have side effects, data so far indicates that retatrutide is considered safe when used as studied. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for chronic low back pain?

Unlike the standard treatments for chronic low back pain, which often include NSAIDs, opioids, or physical therapy, Retatrutide stands out because it is a novel medication administered subcutaneously. Researchers are excited about Retatrutide because it may offer a new mechanism of action, potentially targeting pain pathways differently than traditional pain relievers. This could lead to more effective pain management with fewer side effects, providing hope for patients who haven't found relief with existing therapies.

What evidence suggests that retatrutide might be an effective treatment for chronic low back pain?

Research has shown that retatrutide, which participants in this trial may receive, might help treat chronic low back pain, especially in individuals who are overweight or have obesity. Studies have found that retatrutide can aid in weight loss and improve overall health, potentially reducing back pain. In earlier trials, participants using retatrutide reported experiencing less pain. The treatment is administered as an injection under the skin. Overall, early results suggest that retatrutide is safe and may assist in managing pain and weight. ^{1 2 3 5 6}

Who Is on the Research Team?

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

This trial is for individuals who are overweight or have obesity and suffer from chronic low back pain. Participants will be involved in the study for approximately 80 weeks.

Inclusion Criteria

Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight

I have a history of mainly lower back pain.

My pain is only in my lower back or upper legs.

Exclusion Criteria

I have had a trigger point injection in my spine within the last 6 months.

Have a self-reported change in body weight >5 kilograms (kg) (11 pounds) within 90 days prior to screening

I have used weight loss drugs in the last 90 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Retatrutide or placebo subcutaneously to evaluate efficacy and safety in relieving chronic low back pain

76 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Retatrutide

Trial Overview The study aims to test the effectiveness and safety of a medication called Retatrutide compared to a placebo in relieving chronic low back pain among participants with obesity or overweight.

How Is the Trial Designed?

Group I: Retatrutide Experimental Treatment 1 Intervention

Participants will receive Retatrutide subcutaneously (SC)

Group II: Placebo Placebo Group 1 Intervention

Participants will receive Placebo SC

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07035093

NCT07035093 | A Study of Retatrutide (LY3437943) in ... 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 ...

2. trials.lilly.com trials.lilly.com/en-US/trial/620575

A Study of Retatrutide (LY3437943) in Participants ... - Lilly Trials 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 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12026077/

Efficacy and safety of retatrutide, a novel GLP-1, GIP, and ... Retatrutide demonstrated significant improvements in body weight and metabolic outcomes among adults with obesity and had an appropriate safety profile.

4. clinicaltrials.eu clinicaltrials.eu/trial/study-of-retatrutide-for-patients-with-obesity-overweight-and-chronic-low-back-pain/

Study of Retatrutide for Patients with Obesity, Overweight, ... This clinical trial investigates the efficacy of Retatrutide, a subcutaneous injection, in reducing pain intensity and body weight in patients suffering ...

5. withpower.com withpower.com/trial/phase-3-chronic-lower-back-pain-clbp-4-2025-86097

Retatrutide for Chronic Low Back Pain (TRIUMPH-7 Trial) 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 ...

6. trialx.com trialx.com/clinical-trials/listings/315218/a-study-of-retatrutide-ly3437943-in-participants-who-have-obesity-or-overweight-and-chronic-low-back-pain/

A Study of Retatrutide (LY3437943) in Participants Who ... 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 ...