A Study of Retatrutide (LY3437943) in Participants Who Have Obesity or Overweight and Chronic Low Back Pain (TRIUMPH-7)

Lilly

Status and phase: Not yet enrolling; Phase 3

Conditions: Overweight; Chronic Low Back Pain (CLBP); Obesity

Treatments: Drug: Retatrutide; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07035093

2024-517431-43-00 (EU Trial (CTIS) Number)

27278

J1I-MC-GZQD (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 586 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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586 participants in 2 patient groups, including a placebo group

Retatrutide

Experimental group

Description:

Participants will receive Retatrutide subcutaneously (SC)

Treatment:

Drug: Retatrutide

Placebo

Placebo Comparator group

Description:

Participants will receive Placebo SC

Treatment:

Drug: Placebo