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

Purpose

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.

Conditions

  • Obesity
  • Overweight
  • Chronic Low Back Pain (CLBP)

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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 Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Retatrutide 		Participants will receive Retatrutide subcutaneously (SC)
  • Drug: Retatrutide
    Administered SC
    Other names:
    • LY3437943
Placebo Comparator
Placebo 		Participants will receive Placebo SC
  • Drug: Placebo
    Administered SC

Recruiting Locations

MD First Research - Chandler
Chandler, Arizona 85286
Contact:
480-508-1038

Tucson Orthopaedic Institute - North Wyatt Drive
Tucson, Arizona 85712
Contact:
520-404-0276

Ark Clinical Research - Fountain Valley
Fountain Valley, California 92708
Contact:
714-988-2021

St Joseph Heritage Healthcare
Fullerton, California 92835
Contact:
714-626-8610

Clinical Research Institute
Los Angeles, California 90048
Contact:
323-879-9999

Artemis Institute for Clinical Research
San Diego, California 92123
Contact:
858-278-3647

Alpine Clinical Research Center
Boulder, Colorado 80301
Contact:
303-443-7229

K2 Medical Research - Daytona Beach
Daytona Beach, Florida 32114

Flourish Research - Miami, LLC
Miami, Florida 33135
Contact:
305-631-6704

IMA Clinical Research St. Petersburg
St. Petersburg, Florida 33704
Contact:
727-521-9137

Care Access - Tampa
Tampa, Florida 33625
Contact:
813-771-5980

Charter Research - Lady Lake
The Villages, Florida 32162

Conquest Research
Winter Park, Florida 32789
Contact:
407-916-0060

Cotton O'Neil Clinical Research Center
Topeka, Kansas 66606
Contact:
785-354-9591

Care Access - Lake Charles (Bayou Pines)
Lake Charles, Louisiana 70601
Contact:
337-602-6642

MedVadis Research Corporation
Waltham, Massachusetts 02451
Contact:
617-744-1310

Great Lakes Research Group, Inc.
Bay City, Michigan 48706
Contact:
989-895-9100

Clinvest Headlands Llc
Springfield, Missouri 65807
Contact:
417-883-7889

Center for Clinical Research
Winston-Salem, North Carolina 27103

Altoona Center For Clinical Research
Duncansville, Pennsylvania 16635
Contact:
814-693-0300

New Phase Research and Development
Knoxville, Tennessee 37909

FutureSearch Trials of Neurology
Austin, Texas 78731
Contact:
512-380-9925

Mercy Family Clinic
Dallas, Texas 75208
Contact:
281-944-3610

Houston Research Institute
Houston, Texas 77079
Contact:
281-809-3234

Sovah Clinical Research-River District
Danville, Virginia 24541

More Details

NCT ID
NCT07035093
Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

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

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center