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NCT07035093

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

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

586 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-29

Study Completion Date

2027-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity Overweight Chronic Low Back Pain (CLBP)

Keywords

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Axial Predominant Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Retatrutide

Participants will receive Retatrutide subcutaneously (SC)

Group Type EXPERIMENTAL

Retatrutide

Intervention Type DRUG

Administered SC

Placebo

Participants will receive Placebo SC

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered SC

Interventions

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Retatrutide

Administered SC

Intervention Type DRUG

Placebo

Administered SC

Intervention Type DRUG

Other Intervention Names

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LY3437943

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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MD First Research - Chandler

Chandler, Arizona, United States

Site Status RECRUITING

Tucson Orthopaedic Institute - North Wyatt Drive

Tucson, Arizona, United States

Site Status RECRUITING

Ark Clinical Research - Fountain Valley

Fountain Valley, California, United States

Site Status RECRUITING

St Joseph Heritage Healthcare

Fullerton, California, United States

Site Status RECRUITING

Clinical Research Institute

Los Angeles, California, United States

Site Status RECRUITING

Artemis Institute for Clinical Research

San Diego, California, United States

Site Status RECRUITING

Alpine Clinical Research Center

Boulder, Colorado, United States

Site Status RECRUITING

K2 Medical Research - Daytona Beach

Daytona Beach, Florida, United States

Site Status RECRUITING

Flourish Research - Miami, LLC

Miami, Florida, United States

Site Status RECRUITING

IMA Clinical Research St. Petersburg

St. Petersburg, Florida, United States

Site Status RECRUITING

Care Access - Tampa

Tampa, Florida, United States

Site Status RECRUITING

Charter Research - Lady Lake

The Villages, Florida, United States

Site Status RECRUITING

Conquest Research

Winter Park, Florida, United States

Site Status RECRUITING

Cotton O'Neil Clinical Research Center

Topeka, Kansas, United States

Site Status RECRUITING

Care Access - Lake Charles (Bayou Pines)

Lake Charles, Louisiana, United States

Site Status RECRUITING

MedVadis Research Corporation

Waltham, Massachusetts, United States

Site Status RECRUITING

Great Lakes Research Group, Inc.

Bay City, Michigan, United States

Site Status RECRUITING

Clinvest Headlands Llc

Springfield, Missouri, United States

Site Status RECRUITING

Center for Clinical Research

Winston-Salem, North Carolina, United States

Site Status RECRUITING

Altoona Center For Clinical Research

Duncansville, Pennsylvania, United States

Site Status RECRUITING

New Phase Research and Development

Knoxville, Tennessee, United States

Site Status RECRUITING

FutureSearch Trials of Neurology

Austin, Texas, United States

Site Status RECRUITING

Mercy Family Clinic

Dallas, Texas, United States

Site Status RECRUITING

Houston Research Institute

Houston, Texas, United States

Site Status RECRUITING

Sovah Clinical Research-River District

Danville, Virginia, United States

Site Status RECRUITING

Investigaciones Medicas Imoba Srl

Buenos Aires, , Argentina

Site Status RECRUITING

CIPREC

Buenos Aires, , Argentina

Site Status RECRUITING

Centro Médico Viamonte

Buenos Aires, , Argentina

Site Status RECRUITING

Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

Buenos Aires, , Argentina

Site Status RECRUITING

Fundación Respirar

Buenos Aires, , Argentina

Site Status RECRUITING

Centro de Investigaciones Clínicas Baigorria

Granadero Baigorria, , Argentina

Site Status RECRUITING

Centro Rosarino de Investigaciones Clinicas (CRICs)

Rosario, , Argentina

Site Status RECRUITING

Instituto Médico Catamarca IMEC

Rosario, , Argentina

Site Status RECRUITING

Centro de Diagnóstico y Rehabilitación (CEDIR)

Santa Fe, , Argentina

Site Status RECRUITING

Aggarwal and Associates Limited

Brampton, , Canada

Site Status RECRUITING

Winterberry Research Inc.

Hamilton, , Canada

Site Status RECRUITING

Bluewater Clinical Research Group Inc.

Sarnia, , Canada

Site Status RECRUITING

Care Access - Cape Breton

Sydney, , Canada

Site Status RECRUITING

Dr. Anil K. Gupta Medicine Professional Corporation

Toronto, , Canada

Site Status RECRUITING