Trulicity Shows Superiority in Reducing Weight, A1C

Eli Lilly’s type 2 diabetes drug Trulicity hit the mark in a late-stage trial that showed higher doses of the medication significantly reduced A1C from baseline compared to the once-per-week dose of Trulicity currently on the market.

Trulicity (dulaglutide) is currently approved for type 2 diabetes in a 1.5 mg dose. The medication is approved to improve blood sugar (glucose) in adults with type 2 diabetes mellitus. Patients in the Phase III AWARD-11 trial received doses of 3.0 mg and 4.5 mg. At 36 weeks, the higher doses showed superiority to the 1.5 mg dose, Indianapolis-based Eli Lilly said this morning.

In addition to the reduction of A1C, Eli Lilly said the trial also hit its secondary efficacy endpoints for superiority on weight reduction. The safety and tolerability profile of the investigational Trulicity doses was consistent with the known profile of Trulicity 1.5 mg. The AWARD-11 trial evaluated the safety and efficacy of Trulicity 3.0 mg and 4.5 mg doses in 1,842 participants with type 2 diabetes. All patients in the trial started the study taking a .75 mg dose of Trulicity. Those doses increased in a step-wise approach at four-week intervals to their final randomized maintenance dose of 1.5 mg, 3.0 mg or 4.5 mg.

Diabetes affects approximately 30 million people in the United States and is estimated to affect about 425 million people across the globe. Type 2 diabetes is the most common type and accounts for an estimated 90 to 95 percent of all diabetes cases in the United States alone, Eli Lily said.

Because diabetes is a progressive condition, Brad Woodward, global development leader of Incretins at Eli Lilly, said some patients may need to adjust their treatment regimens to achieve further glycemic control.

“Lilly chose to study additional doses of dulaglutide to provide more options for clinicians and people living with type 2 diabetes. We’re encouraged by the superior results, which showed a significant reduction in A1C beyond the effective Trulicity doses already available,” Woodward said in a statement.

The late-stage AWARD-11 trial will continue through 52 weeks to evaluate longer-term safety data, Eli Lilly said. The trial is expected to be completed by the end of 2019. Lilly said it will share detailed results of the trial at a later date but did not that it intends to submit the data to regulatory authorities later this year regarding potential marketing of the higher doses.