Eli Lilly Initiates First-Ever Phase III Trial of GLP-1R/GIPR/GCGR Triple Agonist Retatrutide for Obesity with Cardiovascular Disease

On May 31, the clinicaltrials.gov website showed that Eli Lilly and Company registered a Phase III clinical trial (TRIUMPH-3), aiming to evaluate the efficacy and safety of once-weekly retatrutide (LY3437943) in treating obese subjects with cardiovascular disease. This product is also the first GLP-1R/GCGR/GIPR agonist to enter the Phase III clinical stage.

TRIUMPH-3 Study (NCT05882045) is a randomized, double-blind Phase III clinical trial planning to enroll 1800 obese subjects with a body mass index (BMI) ≥35kg/m2, who have been diagnosed with at least one cardiovascular disease (myocardial infarction, ischemic or hemorrhagic stroke, symptomatic peripheral artery disease) and have experienced at least one failed dietary weight loss attempt.

The primary endpoint of the study was the change in participants' weight from baseline at Week 80. Secondary endpoints included changes from baseline at Week 80 in waist circumference, total cholesterol, triglycerides, systolic blood pressure, diastolic blood pressure, HbA1c, fasting insulin, Health Survey Short Form (SF-36v2) scores, pharmacokinetics, and other indicators.

Retatrutide is a peptide drug developed by Eli Lilly targeting GLP-1R/GCGR/GIPR based on GIP peptide sequences, with an average half-life of 6 days in humans and 21 hours in mice (0.47mg/kg). Results from the Phase Ia study showed that, compared to placebo, retatrutide (3/6/9/12mg) reduced participants' body weight by 8.96kg. Currently, Eli Lilly completed Phase II clinical trials of retatrutide for type 2 diabetes (NCT04867785) and obesity (NCT04881760) in 2022, but the detailed results have not been published yet.

Currently, there are a total of 7 GLP-1R/GCGR/GIPR agonists in development globally, with only 3 in clinical stages. Efocipegtrutide, developed by Hanmi Pharm, is in Phase II research, prioritizing the development for NASH indication. MWN101, developed by Minfor Bio, was just approved for IND last week. Both Novo Nordisk and Sanofi have attempted to enter the GLP-1R/GCGR/GIPR agonist field but unfortunately withdrew.

As a strong competitor to Novo Nordisk in the GLP-1 field, Eli Lilly's capabilities cannot be underestimated. With tirzepatide, oral small-molecule GLP-1 receptor agonists, and GLP-1 dual/triple agonists in its arsenal, its competitive edge in the market continues to grow. Novo Nordisk is also preparing to launch an oral version of semaglutide for weight loss, while other products in its pipeline, such as CagriSema and NN9389, are waiting to join the battle. How the competition between these two companies will evolve in the future remains highly anticipated.

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