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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Retatrutide |
Participants will receive Retatrutide subcutaneously (SC) |
|
|
Placebo Comparator Placebo |
Participants will receive Placebo SC |
|
Recruiting Locations
Chandler, Arizona 85286
480-508-1038
Tucson, Arizona 85712
520-404-0276
Fountain Valley, California 92708
714-988-2021
Fullerton, California 92835
714-626-8610
Los Angeles, California 90048
323-879-9999
San Diego, California 92123
858-278-3647
Boulder, Colorado 80301
303-443-7229
Daytona Beach, Florida 32114
Miami, Florida 33135
305-631-6704
St. Petersburg, Florida 33704
727-521-9137
Tampa, Florida 33625
813-771-5980
The Villages, Florida 32162
Winter Park, Florida 32789
407-916-0060
Topeka, Kansas 66606
785-354-9591
Lake Charles, Louisiana 70601
337-602-6642
Waltham, Massachusetts 02451
617-744-1310
Bay City, Michigan 48706
989-895-9100
Springfield, Missouri 65807
417-883-7889
Winston-Salem, North Carolina 27103
Duncansville, Pennsylvania 16635
814-693-0300
Knoxville, Tennessee 37909
Austin, Texas 78731
512-380-9925
Dallas, Texas 75208
281-944-3610
Houston, Texas 77079
281-809-3234
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) or1-317-615-4559
LillyTrials@Lilly.com