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

Clinical Trial4 Jun 2026Phase 3

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: 2026-06-04

View original source ↗

Related signals

Strategic Signal

FDA1 Apr 2026New Drug Approval (NDA/BLA)High impact● 10/10i

FDA Approves Foundayo (Orforglipron) — New Drug Approval (NDA/BLA)

FDA approved orforglipron (Foundayo, Eli Lilly) for type 2 diabetes -- a once-daily oral small-molecule GLP-1 receptor agonist. Orforglipron is the first non-peptide oral GLP-1 approved in the US; oral semaglutide (Rybelsus, Novo Nordisk) has been approved for T2D since 2019 and expanded to obesity in January 2026. Unlike Rybelsus, orforglipron requires no fasting or water volume restrictions before dosing.

GLP-1Type 2 diabetesPricing/accessEli Lilly Novo Nordisk

Strategic Signal

Clinical Trial19 Mar 2026Phase 3High impact● 9/10i

Efficacy and Safety of Tirzepatide Once Weekly in Participants Without Type 2 Diabetes Who Have Obesity or Are Overweight With Weight-Related Comorbidities: A Randomized, Double-Blind, Placebo-Controlled Trial (SURMOUNT-1)

Phase 3 SURMOUNT-1 tests once-weekly tirzepatide at three doses versus placebo in adults without type 2 diabetes who have obesity or are overweight with comorbidities. The randomized, double-blind trial targets 2,539 participants with primary efficacy assessment at 72 weeks. This represents tirzepatide's pivotal obesity trial against placebo, potentially supporting Eli Lilly's bid to compete directly with Wegovy in the non-diabetic obesity market. A prediabetes subgroup continues long-term to assess diabetes prevention.

Weight lossGLP-1Eli Lilly

Strategic Signal

FDA19 Mar 2026Supplemental Approval: Efficacy [Priority Review]High impact● 9/10i

FDA Approves Imcivree (Setmelanotide): Supplemental Approval: Efficacy [Priority Review]

FDA approved a supplemental application for Imcivree (setmelanotide, Rhythm) on March 19, 2026, under priority review. This represents an efficacy-based label expansion for the melanocortin-4 receptor agonist, which was initially approved for rare genetic obesity disorders. Rhythm gains additional indication breadth in the specialized rare obesity market, where treatment options remain extremely limited. The priority review designation signals FDA recognition of significant unmet medical need in the expanded patient population.

Weight lossOtherRhythm

Strategic Signal

Clinical Trial17 Apr 2026Phase 3High impact● 8/10i

A Phase 3, Open-Label Study of Once Daily LY3502970 Compared With Insulin Glargine in Adult Participants With Type 2 Diabetes and Obesity or Overweight at Increased Cardiovascular Risk

Phase 3 open-label trial compared once-daily oral orforglipron versus insulin glargine in people with type 2 diabetes and obesity or overweight at increased cardiovascular risk. The study enrolled 2,749 participants with primary endpoint of time to first major adverse cardiovascular event, completed in March 2026. Eli Lilly is positioning orforglipron as a cardiovascular outcomes option in high-risk populations, directly competing with established insulin therapy in this indication. This represents the first cardiovascular outcomes trial for orforglipron following its April 2026 FDA approval for type 2 diabetes.

GLP-1Type 2 diabetesWeight lossCardiovascularEli Lilly