A Phase 3b Study to Investigate the Efficacy and Safety of Different Retatrutide Dose Escalation Schemes in Participants Without Type 2 Diabetes Who Have Obesity or Overweight: A Randomized, Controlled, Double-Blind Trial

ClinicalTrials20 Apr 2026·Phase 3

A Phase 3b Study to Investigate the Efficacy and Safety of Different Retatrutide Dose Escalation Schemes in Participants Without Type 2 Diabetes Who Have Obesity or Overweight: A Randomized, Controlled, Double-Blind Trial

Eli Lilly and Company

Phase 3b trial evaluating different retatrutide dose escalation strategies in adults with obesity or overweight without type 2 diabetes. Target enrollment is 600 participants with approximately 113 weeks study duration in a randomized, double-blind, controlled design. Eli Lilly is testing optimization of their triple agonist dosing in the weight management indication, building on tirzepatide's success in the same population. This represents systematic dose-finding work for retatrutide ahead of potential regulatory filings.

Strategic signal

Eli Lilly is methodically building the retatrutide evidence package for obesity with dose optimization studies, following their successful tirzepatide playbook that led to Zepbound approval. The dose escalation focus suggests Lilly learned from early retatrutide trials where tolerability issues emerged at higher doses. This systematic approach positions retatrutide for differentiated labeling versus tirzepatide on dosing convenience or tolerability, potentially supporting premium pricing in the crowded GLP-1 obesity market.

GLP-1Weight lossEli Lilly

Original Abstract

The purpose of this study is to investigate the efficacy and safety of different retatrutide dose escalation schemes in participants without type 2 diabetes who have obesity or overweight. Participation in the study will last about 113 weeks. | Condition(s): Obesity; Overweight | Primary endpoint(s): Percent Change from Baseline in Body Weight | Enrollment: 600 (estimated) | Phase: Phase 3 | Sponsor: Eli Lilly and Company | Expected completion: 2028-10 | Status: Recruiting | Last update: 2026-04-20

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