DRUG
Retatrutide
Administered SC
A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight and Chronic Low Back Pain
Status
Active, not recruiting
Phase
Phase 3
Enrollment
586
Locations
40
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
DRUG
Placebo
Administered SC
Timeline
From registration to results.
First posted
Jun 24, 2025
Study start
May 29, 2025
Primary completion
Sep 2027
Study completion
Sep 2027
Results posted
Not reported
Registry updated
Jul 23, 2026
Outcomes
What the study measures.
Primary outcomes
Change from Baseline in Pain Intensity Per Numeric Rating Scale
Time frame · Baseline, up to 72 weeks
Percent Change from Baseline in Body Weight
Time frame · Baseline, up to 72 weeks
Secondary outcomes
Number of Participants with Reduction in Pain Intensity Per Numeric Rating Scale
Time frame · Baseline, up to 72 weeks
Number of Participants with Reduction in Body Weight
Time frame · Baseline, up to 72 weeks
Change in Physical Function as Measured by Patient-Reported Outcomes Measurement Information Systems (PROMIS)
Time frame · Baseline, up to 72 weeks
Change in Pain Interference as Measured by PROMIS
Time frame · Baseline, up to 72 weeks
Change in Sleep as Measured by PROMIS
Time frame · Baseline, up to 72 weeks
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
Change in Waist Circumference
Time frame · Baseline, up to 72 weeks
Change in Biomarkers of Inflammation as Measured by Blood Test
Time frame · Baseline, up to 72 weeks
Change in Blood Pressure
Time frame · Baseline, up to 72 weeks
Change in Glycemic Control
Time frame · Baseline, up to 72 weeks
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
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
Study locations
40 registered sites.
Argentina · Canada · Poland · United States. Showing up to 24 locations stored in the fast local snapshot.
MD First Research - Chandler
Chandler, Arizona, United States
Tucson Orthopaedic Institute - North Wyatt Drive
Tucson, Arizona, United States
Ark Clinical Research - Fountain Valley
Fountain Valley, California, United States
St Joseph Heritage Healthcare
Fullerton, California, United States
Clinical Research Institute
Los Angeles, California, United States
Artemis Institute for Clinical Research
San Diego, California, United States
Alpine Clinical Research Center
Boulder, Colorado, United States
K2 Medical Research - Daytona Beach
Daytona Beach, Florida, United States
Flourish Research - Miami, LLC
Miami, Florida, United States
IMA Clinical Research St. Petersburg
St. Petersburg, Florida, United States
Care Access - Tampa
Tampa, Florida, United States
Charter Research - Lady Lake
The Villages, Florida, United States
Conquest Research
Winter Park, Florida, United States
Cotton O'Neil Clinical Research Center
Topeka, Kansas, United States
Care Access - Lake Charles (Bayou Pines)
Lake Charles, Louisiana, United States
MedVadis Research Corporation
Waltham, Massachusetts, United States
Great Lakes Research Group, Inc.
Bay City, Michigan, United States
Clinvest Headlands Llc
Springfield, Missouri, United States
Center for Clinical Research
Winston-Salem, North Carolina, United States
Altoona Center For Clinical Research
Duncansville, Pennsylvania, United States
New Phase Research and Development
Knoxville, Tennessee, United States
FutureSearch Trials of Neurology
Austin, Texas, United States
Mercy Family Clinic
Dallas, Texas, United States
Houston Research Institute
Houston, Texas, United States
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Retatrutide.
NCT IDStudyPhase / statusEnrollmentUpdated
A Study of Retatrutide (LY3437943) in Participants With Obesity and Cardiovascular Disease
Eli Lilly · Obesity · Cardiovascular Diseases
Phase 3
Completed
1,946
2026-07
A Study of Retatrutide (LY3437943) in Participants With Type 2 Diabetes Mellitus Who Have Obesity or Overweight
Eli Lilly · Type 2 Diabetes · Obesity
Phase 3
Completed
1,152
2026-07
Effect of Retatrutide Compared With Placebo in Participants With Type 2 Diabetes and Moderate or Severe Renal Impairment, With Inadequate Glycemic Control on Basal Insulin, With or Without Metformin and/or SGLT2 Inhibitor (TRANSCEND-T2D-3)
Eli Lilly · Type 2 Diabetes
Phase 3
Active, not recruiting
320
2026-07
The Effect of Retatrutide Once Weekly on Cardiovascular Outcomes and Kidney Outcomes in Adults Living With Obesity (TRIUMPH-Outcomes)
Eli Lilly · Atherosclerotic Cardiovascular Disease (ASCVD) · Chronic Kidney Disease (CKD)
Phase 3
Active, not recruiting
10,000
2026-07
A Study of Retatrutide (LY3437943) Compared to Tirzepatide (LY3298176) in Adults Who Have Obesity
Eli Lilly · Obesity
Phase 3
Active, not recruiting
800
2026-07
A Master Protocol of Multiple Agents in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (SYNERGY-Outcomes)
Eli Lilly · Metabolic Dysfunction-Associated Steatotic Liver Disease
Phase 3
Recruiting
4,500
2026-07
A Study to Evaluate the Effect of Retatrutide on Insulin Secretion and Insulin Sensitivity in Adult Participants With Type 2 Diabetes Mellitus
Eli Lilly · Diabetes Mellitus · Insulin Sensitivity
Phase 1
Active, not recruiting
95
2026-07
A Study to Investigate the Response of Participants With Type 2 Diabetes Mellitus on Once-Weekly Retatrutide to Hypoglycemia
Eli Lilly · Type 2 Diabetes Mellitus
Phase 1
Completed
80
2026-06
Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.