Lilly Initiates Two Phase III Trials of GLP-1R/GIPR/GCGR Agonist Retatrutide for Obesity and Type 2 Diabetes

On July 3, 2023, Eli Lilly registered two Phase III clinical trials on Clinicaltrials.gov for Retatrutide, a GLP-1R/GIPR/GCGR triagonist for the treatment of obesity/overweight patients. The study codes are TRIUMPH-1 and TRIUMPH-2, respectively.

In the two Phase III studies registered this time, TRIUMPH-1 targets obesity/overweight and includes patient subgroups such as osteoarthritis (OA) and obstructive sleep apnea (OSA), with an estimated enrollment of 2,100 patients; TRIUMPH-2 targets type 2 diabetes patients with comorbid obesity/overweight and also includes the OSA subgroup, with an estimated enrollment of 1,000 patients. Both studies are international multicenter clinical trials, and the regions where they are conducted include China.

TRIUMPH-1/2 Research Center

On June 26, Eli Lilly and Company announced the latest data from the Phase II study (NCT 04881760) of Retatrutide for obesity treatment. At 24 weeks, Retatrutide (1 mg, 4 mg, 8 mg, or 12 mg) achieved 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 secondary endpoints, Retatrutide achieved an average weight loss of 24.2% (26.2 kg) at the end of 48 weeks of treatment.。

In addition, Retatrutide demonstrated a favorable safety profile. The most commonly reported adverse events were gastrointestinal reactions, which were generally mild to moderate and typically occurred during the dose-escalation period.

Eli Lilly is also accelerating the Phase III TRIUMPH study of Retatrutide. The study 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).

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