Actively Recruiting
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
Led by Eli Lilly and Company · Updated on 2026-05-20
586
Participants Needed
40
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of retatrutide in easing chronic low back pain in adults who are overweight or have obesity. This phase 3 study is designed as a randomized, double-blind, placebo-controlled trial sponsored by Eli Lilly and Company. The trial aims to measure changes in pain intensity and body weight over time to better understand retatrutide's impact in this group. Participants will be randomly assigned to receive either retatrutide or a placebo, both given as injections under the skin once weekly. The study lasts about 80 weeks, with assessments occurring up to 72 weeks from the baseline. The trial focuses on evaluating pain relief and weight changes, comparing the study drug to placebo under controlled conditions. Throughout the study, participants will undergo various assessments including pain intensity ratings, body weight measurements, and evaluations of physical function, sleep, and health-related quality of life using patient-reported questionnaires. Blood tests will monitor biomarkers of inflammation, blood pressure, glycemic control, cholesterol levels, and kidney function. The research team will track these outcomes regularly to assess safety and treatment effects over the nearly two-year participation period.
CONDITIONS
Brief Title
A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight and Chronic Low Back Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have a history of axial-predominant low back pain
- Have pain restricted to the low back or with referral limited to the proximal legs
- Have a body mass index (BMI) of 27 kg/m2 or higher at screening
- Have a history of at least one unsuccessful attempt to lose body weight through diet
You will not qualify if you...
- Have low back pain from a non-axial origin
- Had botulinum or steroid injections to the spine within 1 year before screening
- Had trigger point injections to the spine within 6 months before screening
- Experienced a body weight change greater than 5 kilograms within 90 days before screening
- Have taken drugs to promote weight loss, including over-the-counter medications, within 90 days before screening
- Have had prior or planned surgical treatment for obesity
- Have Type 1 Diabetes, Type 2 Diabetes, or any other form of diabetes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 72 weeks
Participants receive Retatrutide or placebo by subcutaneous injection once weekly to treat obesity or overweight and chronic low back pain.
Weekly visits for up to 72 weeks
Trial Site Locations
Total: 40 locations
1
MD First Research - Chandler
Chandler, Arizona, United States, 85286
Actively Recruiting
2
Tucson Orthopaedic Institute - North Wyatt Drive
Tucson, Arizona, United States, 85712
Actively Recruiting
3
Ark Clinical Research - Fountain Valley
Fountain Valley, California, United States, 92708
Actively Recruiting
4
St Joseph Heritage Healthcare
Fullerton, California, United States, 92835
Actively Recruiting
5
Clinical Research Institute
Los Angeles, California, United States, 90048
Actively Recruiting
6
Artemis Institute for Clinical Research
San Diego, California, United States, 92123
Actively Recruiting
7
Alpine Clinical Research Center
Boulder, Colorado, United States, 80301
Actively Recruiting
8
K2 Medical Research - Daytona Beach
Daytona Beach, Florida, United States, 32114
Actively Recruiting
9
Flourish Research - Miami, LLC
Miami, Florida, United States, 33135
Actively Recruiting
10
IMA Clinical Research St. Petersburg
St. Petersburg, Florida, United States, 33704
Actively Recruiting
11
Care Access - Tampa
Tampa, Florida, United States, 33625
Actively Recruiting
12
Charter Research - Lady Lake
The Villages, Florida, United States, 32162
Actively Recruiting
13
Conquest Research
Winter Park, Florida, United States, 32789
Actively Recruiting
14
Cotton O'Neil Clinical Research Center
Topeka, Kansas, United States, 66606
Actively Recruiting
15
Care Access - Lake Charles (Bayou Pines)
Lake Charles, Louisiana, United States, 70601
Actively Recruiting
16
MedVadis Research Corporation
Waltham, Massachusetts, United States, 02451
Actively Recruiting
17
Great Lakes Research Group, Inc.
Bay City, Michigan, United States, 48706
Actively Recruiting
18
Clinvest Headlands Llc
Springfield, Missouri, United States, 65807
Actively Recruiting
19
Center for Clinical Research
Winston-Salem, North Carolina, United States, 27103
Actively Recruiting
20
Altoona Center For Clinical Research
Duncansville, Pennsylvania, United States, 16635
Actively Recruiting
21
New Phase Research and Development
Knoxville, Tennessee, United States, 37909
Actively Recruiting
22
FutureSearch Trials of Neurology
Austin, Texas, United States, 78731
Actively Recruiting
23
Mercy Family Clinic
Dallas, Texas, United States, 75208
Actively Recruiting
24
Houston Research Institute
Houston, Texas, United States, 77079
Actively Recruiting
25
Sovah Clinical Research-River District
Danville, Virginia, United States, 24541
Actively Recruiting
26
Investigaciones Medicas Imoba Srl
Buenos Aires, Argentina, C1056ABH
Actively Recruiting
27
CIPREC
Buenos Aires, Argentina, C1061AAS
Actively Recruiting
28
Centro Médico Viamonte
Buenos Aires, Argentina, C1120AAC
Actively Recruiting
29
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Buenos Aires, Argentina, C1425AGC
Actively Recruiting
30
Fundación Respirar
Buenos Aires, Argentina, C1426ABP
Actively Recruiting
31
Centro de Investigaciones Clínicas Baigorria
Granadero Baigorria, Argentina, 2152
Actively Recruiting
32
Centro Rosarino de Investigaciones Clinicas (CRICs)
Rosario, Argentina, 2000
Actively Recruiting
33
Instituto Médico Catamarca IMEC
Rosario, Argentina, 2000
Actively Recruiting
34
Centro de Diagnóstico y Rehabilitación (CEDIR)
Santa Fe, Argentina, 3000
Actively Recruiting
35
Aggarwal and Associates Limited
Brampton, Canada, L6T 0G1
Actively Recruiting
36
Winterberry Research Inc.
Hamilton, Canada, L8J 0B6
Actively Recruiting
37
Bluewater Clinical Research Group Inc.
Sarnia, Canada, N7T 4X3
Actively Recruiting
38
Care Access - Cape Breton
Sydney, Canada, B1M 0A1
Actively Recruiting
39
Dr. Anil K. Gupta Medicine Professional Corporation
Toronto, Canada, M9V 4B4
Actively Recruiting
40
Podlaskie Centrum Psychogeriatrii
Bialystok, Poland, 15-756
Completed
Research Team
T
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
P
Physicians interested in becoming principal investigators please contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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