TRIUMPH-7

RecruitingPhase 3

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

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Retatrutide Once Weekly in Participants Who Have Obesity or Overweight and Chronic Low Back Pain

Lead sponsor

Eli Lilly and Company

Asset

Retatrutide

Subcutaneous · GLP-1 / GIP / glucagon triple

Listed sites

Recruiting sites

Enrollment

586

estimated

Study population

Obesity / overweight, Pain

Key I/E criterion

•BMI ≥27

Primary endpoints

•Pain Intensity•Body weight, % change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07035093

Org study ID27278

Secondary ID2024-517431-43-00

Secondary IDJ1I-MC-GZQDEli Lilly and Company

Timeline

Milestones

Study start2025-05-29actual

Study first posted2025-06-24actual

Last update posted2026-05-20actual

Primary completion2027-09estimated (month precision)

Study completion2027-09estimated (month precision)

Assets

Investigational agents

Retatrutide

Study populations

Who this study enrolls

Obesity / overweightPain

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (14)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Patient-reported / QoL

Weight & body composition

Cardiometabolic biomarkers

Other clinical outcomes

Glycemic / diabetes

Renal / kidney

Weight & body composition

3 endpoints

Primary/protocol endpoint

Percent Change from Baseline in Body Weight

Time frame:Baseline, up to 72 weeks

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint/low confidence

Number of Participants with Reduction in Body Weight

Time frame:Baseline, up to 72 weeks

threshold achievement, improvement

Secondary/protocol endpoint

Change in Waist Circumference

Time frame:Baseline, up to 72 weeks

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

1 endpoint

Secondary/protocol endpoint/low confidence

Change in Glycemic Control

Time frame:Baseline, up to 72 weeks

change from baseline, improvement

Renal / kidney

1 endpoint

Secondary/protocol endpoint

Percent Change in Urine Albumin-to-Creatinine Ratio (UACR)

Time frame:Baseline, up to 72 weeks

uACR, % change

percent change from baseline, improvement

LOINC 9318-7

Cardiometabolic biomarkers

3 endpoints

Secondary/protocol endpoint/low confidence

Change in Biomarkers of Inflammation as Measured by Blood Test

Time frame:Baseline, up to 72 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in Blood Pressure

Time frame:Baseline, up to 72 weeks

change from baseline, improvement

Secondary/protocol endpoint

Percent Change in Total Cholesterol

Time frame:Baseline, up to 72 weeks

Total cholesterol, change

percent change from baseline, improvement

LOINC 2093-3

Patient-reported / QoL

4 endpoints

Secondary/protocol endpoint

Change in Physical Function as Measured by Patient-Reported Outcomes Measurement Information Systems (PROMIS)

Time frame:Baseline, up to 72 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in Pain Interference as Measured by PROMIS

Time frame:Baseline, up to 72 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in Sleep as Measured by PROMIS

Time frame:Baseline, up to 72 weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in Patient Reported Health Outcomes as Measured by Medical Outcomes Study 36-item Short Form Health Survey version 2 (SF-36v2)

Time frame:Baseline, up to 72 weeks

SF-36 total

change from baseline, improvement

Other clinical outcomes

2 endpoints

Primary/protocol endpoint

Change from Baseline in Pain Intensity Per Numeric Rating Scale

Time frame:Baseline, up to 72 weeks

change from baseline, improvement

Secondary/protocol endpoint

Number of Participants with Reduction in Pain Intensity Per Numeric Rating Scale

Time frame:Baseline, up to 72 weeks

threshold achievement, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.