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

Clinical Trial20 May 2026Phase 3

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

Eli Lilly and Company

Phase 3 trial evaluating retatrutide for chronic low back pain in people with obesity or overweight, targeting dual primary endpoints of pain intensity reduction and weight loss. 586-person placebo-controlled study expected to complete September 2027, investigating a novel indication beyond traditional metabolic endpoints. Eli Lilly is exploring pain management as a potential expansion for their triple agonist, representing the first major trial of a GLP-1-based therapy specifically for chronic pain conditions.

Strategic Signal

Eli Lilly is pioneering GLP-1 therapy expansion into pain management, potentially opening a massive new market beyond diabetes and obesity. Success could establish precedent for metabolic agents in chronic pain, where current treatments have limited efficacy and significant side effect burdens. This strategy positions retatrutide for broader patient populations and could influence how payers view GLP-1 value propositions, particularly given chronic low back pain affects over 80 million Americans with annual costs exceeding $100 billion.

GLP-1Weight lossOtherEli Lilly

Original Abstract

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. | Condition(s): Obesity; Overweight; Chronic Low Back Pain (CLBP) | Primary endpoint(s): Change from Baseline in Pain Intensity Per Numeric Rating Scale; Percent Change from Baseline in Body Weight | Enrollment: 586 (estimated) | Phase: Phase 3 | Sponsor: Eli Lilly and Company | Expected completion: 2027-09 | Status: Recruiting | Last update: 2026-05-20

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