Lilly, Novo Nordisk Present Promising Data in Type 2 Diabetes
Eli Lilly's investigational diabetes drug is showing significant promise in targeting A1C levels and weight loss in patients with type 2 diabetes, including those who had never been previously treated for the disease. All three doses of the investigational drug generated statistically significant results.
Data published in The Lancet and presented at the American Diabetes Association's 81st Scientific Sessions showed that Eli Lilly's tirzepatide, a dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist, reduced A1C by up to 2.07% and body weight by up to 20.9 pounds, about 11% compared to placebo in the SURPASS-1 study. More than half of the patients in the Phase III study, 54.2%, were treatment-naïve, with a baseline A1C of 7.9% and a baseline weight of 189 pounds. Up to 52% of trial participants achieved an A1C of less than 5.7%, which is a level seen in people without diabetes.
At the 15 mg, highest dose of tirzepatide, total cholesterol was reduced by 8.4%, triglycerides were reduced by 21%, low-density lipoprotein (LDL) cholesterol was reduced by 12.%, very low-density lipoprotein (VLDL) cholesterol was reduced by 19.8%, and high-density lipoprotein (HDL) cholesterol was increased by 7.5%.
Even the lowest dose of tirzepatide generated positive results in patients. Eli Lilly noted that the 5mg dose led to A1C and body weight reductions of 1.87% and 15 pounds.
The use of tirzepatide also led to improvements in the change in fasting serum glucose from baseline and improvements in the change in two-hour post-meal glucose values from baseline.
Julio Rosenstock, Director of the Dallas Diabetes Research Center at Medical City and Principal Investigator of SURPASS-1, said the SURPASS-1 study was designed to investigate the impact of tirzepatide as a monotherapy in multiple diabetes disease targets, including glycemic control and weight loss.
"Type 2 diabetes is a progressive disease, and many people with the condition have trouble reaching their A1C goals through diet and exercise. 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," Rosenstock said in a statement.
Based on the positive results from the SURPASS-1 study, Eli Lilly intends to file for regulatory approval by the end of this year.
The overall safety profile of tirzepatide was similar to other GLP-1 agonists. Lilly is also investigating tirzepatide as a potential treatment for non-alcoholic steatohepatitis (NASH) and heart failure with preserved ejection fraction (HFpEF).
Eli Lilly wasn't the only company to present positive data at the ADA meeting. Novo Nordisk also presented data showing an investigational 2mg dose of injectable Ozempic (semaglutide) generated statistically significant and superior reductions in A1C compared to a 1mg dose of Ozempic.
The Phase IIIb SUSTAIN FORTE trial assessed the once-per-week injectable version of Ozempic to 1mg Ozempic as an add-on to metformin with or without sulfonylureas in type 2 diabetes. The data was presented at the ADA conference and also published in The Lancet Diabetes & Endocrinology.
The trial hit its primary endpoint by reducing A1C levels by 2.2%, compared to 1.9% with the 1mg dose of Ozempic. Patients in the study have an elevated mean baseline A1C of 8.9%. The results were statistically significant.
Additionally, other post hoc subgroup analyses showed the injectable version of Ozempic demonstrated higher reductions in blood sugar at 40 weeks compared with Ozempic 1 mg across all baseline A1C subgroups. The injectable Ozempic version also generated weight loss in patients. For patients with a mean baseline body weight of 219 pounds, the injectable formula caused weight loss of an average of 15.2 pounds compared to 13.2 pounds for Ozempic 1mg.
Juan Pablo Frias, medical director of the National Research Institute in Los Angeles and principal investigator of SUSTAIN FORTE, said some type 2 diabetes patients need additional support to reach blood glucose targets.
"The reductions in blood glucose seen with semaglutide 2 mg demonstrate that a higher dose of Ozempic may offer individuals the opportunity to further improve their diabetes control, with comparable tolerability to Ozempic 1 mg," Frias said in a statement.