A Phase 3, Randomized, Multicenter, Open-label Study to Investigate the Efficacy and Safety of Retatrutide Once Weekly Compared With Semaglutide Once Weekly in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin With or Without SGLT2 Inhibitor (TRANSCEND-T2D-2)

Clinical Trial13 Apr 2026Phase 3● 7/10i

A Phase 3, Randomized, Multicenter, Open-label Study to Investigate the Efficacy and Safety of Retatrutide Once Weekly Compared With Semaglutide Once Weekly in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin With or Without SGLT2 Inhibitor (TRANSCEND-T2D-2)

Eli Lilly and Company

Phase 3 open-label trial comparing retatrutide with semaglutide in adults with type 2 diabetes inadequately controlled on metformin with or without SGLT2 inhibitor. The study enrolls 1,250 participants over 26 months, targeting HbA1c reduction as the primary endpoint, with completion expected August 2026. Eli Lilly positions retatrutide as a direct competitor to semaglutide in the core type 2 diabetes market, testing their triple-receptor agonist against the current GLP-1 standard. The head-to-head design provides comparative evidence needed for formulary positioning and prescriber confidence.

Strategic Signal

Eli Lilly's head-to-head design against semaglutide creates the comparative evidence US payers demand for tier placement decisions. Unlike single-arm trials, this direct comparison enables Lilly to make superiority claims in promotional materials and formulary presentations. The 26-month duration captures durability data that US commercial plans increasingly require for specialty tier coverage. Completion in August 2026 positions retatrutide data ahead of Novo's next-generation pipeline, potentially securing first-mover advantage in triple-receptor mechanisms.

GLP-1Type 2 diabetesDrug comparisonsEli Lilly Novo Nordisk

Original Abstract

The purpose of this study is to investigate the efficacy and safety of retatrutide compared with semaglutide in participants with Type 2 Diabetes and inadequate glycemic control with metformin with or without sodium-glucose cotransporter-2 inhibitor (SGLT2i). The study will last about 26 months and may include up to 24 visits. | Condition(s): Diabetes Mellitus, Type 2 | Primary endpoint(s): Change from Baseline in Hemoglobin A1c (HbA1c) (%) | Enrollment: 1,250 (estimated) | Phase: Phase 3 | Sponsor: Eli Lilly and Company | Expected completion: 2026-08 | Status: Active Not Recruiting | Last update: 2026-04-13

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