A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Once Weekly Eloralintide in Adult Participants With Persistent Obesity or Overweight Treated With a Weekly Incretin, With and Without Type 2 Diabetes

ClinicalTrials17 Apr 2026·Phase 3● 7/10i

A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Once Weekly Eloralintide in Adult Participants With Persistent Obesity or Overweight Treated With a Weekly Incretin, With and Without Type 2 Diabetes

Eli Lilly and Company

Phase 3 randomized placebo-controlled trial testing once-weekly eloralintide in adults with persistent obesity or overweight on stable incretin therapy, with or without type 2 diabetes. Enrolling 900 participants over 80 weeks, targeting percent change in body weight from baseline. Eli Lilly is exploring combination therapy for people who have insufficient weight loss on existing GLP-1 agents, addressing a growing clinical need as incretin adoption expands. The add-on approach represents a different strategy from Novo Nordisk's CagriSema fixed-dose combination currently in Phase 3.

Strategic signal

This targets the emerging 'non-responder' population on GLP-1 monotherapy, potentially creating a second-line obesity market. Unlike fixed combinations, an add-on approach allows dose titration flexibility and preserves existing GLP-1 prescribing patterns. US payers will likely require step therapy documentation showing inadequate response to first-line incretin therapy, mirroring diabetes combination drug coverage policies.

GLP-1Weight lossDrug comparisonsEli Lilly

Original Abstract

The main purpose of this study is to evaluate the efficacy and safety of eloralintide compared with placebo in participants with persistent obesity or overweight, with or without type 2 diabetes, and on stable incretin background therapy. Participation in the study will last about 80 weeks. | Condition(s): Overweight; Obesity | Primary endpoint(s): Percent Change from Baseline in Body Weight | Enrollment: 900 (estimated) | Phase: Phase 3 | Sponsor: Eli Lilly and Company | Expected completion: 2028-06 | Status: Recruiting | Last update: 2026-04-17

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