Diabetes drug tirzepatide associated with ‘significant improvements’ as Eli Lilly prepares for FDA filing
Monotherapy with tirzepatide is associated with significant improvements in glycemic control and weight loss among patients with type 2 diabetes, according to new research presented at the American Diabetes Association’s 81st Scientific Sessions. The group’s full analysis was also published in The Lancet.
Tirzepatide is a new once-weekly dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist manufactured by Eli Lilly and Company. The results of this study, and others, are expected to play a key role when Eli Lilly applies for FDA approval in late 2021.
The SURPASS-1 clinical trial included more than 450 patients treated with one of three different doses of tirzepatide—5 mg, 10 mg or 15 mg—or a placebo. Patients participated from June 3, 2019, to Oct. 28, 2020. At 40 weeks, the team found that all three tirzepatide doses were superior to the placebo.
“Type 2 diabetes is a progressive disease, and many people with the condition have trouble reaching their A1C goals through diet and exercise,” Julio Rosenstock, MD, director of the Dallas Diabetes Research Center and principal investigator of the SURPASS-1 trial, said in a statement from Eli Lilly. “This monotherapy clinical trial was designed to assess the impact of tirzepatide alone on several important diabetes treatment targets, including glycemic control and weight loss. In the SURPASS-1 results, tirzepatide led to significant improvements across all primary and key secondary endpoints with clinically meaningful A1C reductions and robust weight loss among study participants, who had a relatively short duration of type 2 diabetes.”
The team reported no cases of severe hypoglycemia or hypoglycemia less than 54 mg/dL.
Certain complications— nausea and diarrhea, for example—were more common among patients taking tirzepatide compared to the placebo, the team added.
The SURPASS-1 clinical trial was funded by Eli Lilly.
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