Lilly Initiates Phase III Head-to-Head Trial of GLP-1R/GIPR/GCGR Agonist Retatrutide Versus Semaglutide in Type 2 Diabetes
Eli Lilly
Global Pharmaceutical R&D and Production Company
On February 15, a randomized, multicenter, open-label Phase III clinical trial (study code: TRANSCEND-T2D-2, NCT06260722) of retatrutide, a GLP-1R/GIPR/GCGR triagonist, was registered on the clinicaltrials.gov website. The trial aims to evaluate the efficacy and safety of retatrutide compared to semaglutide in patients with type 2 diabetes who have inadequate glycemic control with metformin alone or in combination with a sodium-glucose cotransporter-2 inhibitor (SGLT2i).
The study is expected to be initiated on March 20 this year and will complete the primary research by December 11, 2026, with the entire study concluding on March 30, 2027. The study will last approximately 26 months, potentially including up to 24 visits, with an anticipated enrollment of 1,250 patients.The primary endpoint was the change (%) in patients' hemoglobin A1c (HbA1c) values from baseline at Week 80.
Currently, Eli Lilly is also accelerating the Phase III TRIUMPH series of studies for retatrutide, which includes four pivotal registrational trials aimed at evaluating the safety and efficacy of retatrutide for chronic weight management in patients with obesity and overweight, as well as for obstructive sleep apnea (OSA) and knee osteoarthritis (OA). Specifically:
TRIUMPH-1: A randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of retatrutide in obese or overweight non-type 2 diabetes subjects (including subjects with OSA and OA). TRIUMPH-2: A randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of retatrutide in obese or overweight subjects with type 2 diabetes (including OSA subjects) TRIUMPH-3: A randomized, double-blind, placebo-controlled trial aimed at grade 2 obesity (BMI≥35kg/m2And<40kg/m2) orGrade 3 Obesity (BMI≥40kg/m2) and has established cardiovascularTubeEvaluation of the Efficacy and Safety of Retatrutide in Subjects with Diseases TRIUMPH-4: A randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of retatrutide in obese or overweight subjects with OA
In June 2023, Eli Lilly and Company announced the Phase II study (NCT 04881760) data of retatrutide for obesity treatment. At 24 weeks, Retatrutide (1mg, 4mg, 8mg, or 12mg) met the primary endpoint using efficacy estimands in non-diabetic subjects who were obese or overweight, with an average weight loss of 17.5% (18.7 kg). For the secondary endpoint, Retatrutide achieved an average weight loss of 24.2% (26.2 kg) at the end of 48 weeks of treatment.
Retatrutide treatment is associated with improvements in cardiometabolic parameters (exploratory endpoints), including systolic and diastolic blood pressure, triglycerides, low-density lipoprotein cholesterol, total cholesterol, glycated hemoglobin, and fasting glucose and insulin levels at weeks 24 and 48.
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