Eli Lilly has showcased new positive data for its investigational type 2 diabetes drug tirzepatide at Annual Scientific Sessions of the American Diabetes Association (ADA).
Tirzepatide is an investigational once-weekly dual glucose-dependent insulinotropic polypeptide (GIP) and GLP-1 receptor agonist.
In the SURPASS-1 trial, three doses of tirzepatide – 5 mg, 10 mg and 15 mg – as monotherapy were compared to placebo in adults with type 2 diabetes, whose condition was inadequately controlled with diet and exercise alone.
According to Lilly, 54.2% of study participants in this trial were treatment-naive and had a relatively short mean duration of diabetes – 4.7 years – with a baseline A1C of 7.9% and a baseline weight of 85.8 kg.
The data shows that tirzepatide reduced A1C by up to 2.07% and body weight by up to 9.5 kg compared to placebo.
In addition, up to 52% of participants achieved an A1C less than 5.7%, which is the level seen in people with diabetes.
Tirzepatide also led to further improvements including the change in serum glucose from baseline and in the change in two-hour post-meal glucose values from baseline, as measured by self-monitored blood glucose data.
An additional exploratory endpoints also showed that all doses of tirzepatide led to ‘favourable’ changes from baseline in fasting lipids.
That includes an 8.4% reduction of total cholesterol for patients treated with the highest tirzepatide dose (15mg) – also at this dose, triglycerides were reduced by 21%, low-density lipoprotein (LDL) cholesterol was reduced by 12.4%, very low-density lipoprotein (VLDL) cholesterol was reduced by 19.8% and high-density lipoprotein (HDL) cholesterol was increased by 7.5%.
The overall treatment discontinuation rates were greater for the highest tirzepatide dose, with 21.5% of participants dropping out at this dose level compared to 14.8% on placebo.
The drop-out rates for the tirzepatide 5 mg and 10 mg doses were 9.1% and 9.9%, respectively.
“Type 2 diabetes is a progressive disease, and many people with the condition have trouble reaching their A1C goals through diet and exercise. 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,” said Julio Rosenstock, principal investigator of the SURPASS-1 trial.
“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,” he added.
Lilly is planning to submit the full data package for tirzepatide to regulatory authorities by the end of 2021, the company said in a statement.