Eli Lilly’s highly anticipated tirzepatide, a once-weekly dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide 1 receptor agonist (GLP-1RA), recently demonstrated that it was able to not only reduce HbA1c levels in type 2 diabetes (T2D) patients, but also confer weight loss when compared to insulin glargine in the SURPASS-4 trial. Tirzepatide has the potential to achieve blockbuster status, if approved, by helping to address the growing epidemic in T2D, inducing significant weight loss, and continuing to outperform incumbent giants in head-to-head clinical trials, says GlobalData, a leading data and analytics company.

SURPASS-4 is a randomized (2,002 study participants), parallel, open-label Phase III clinical trial investigating treatment with tirzepatide (5mg, 10mg, and 15mg) compared to insulin glargine in T2D adult patients who have an increased risk of cardiovascular disease and are inadequately controlled with oral T2D medications.

Tirzepatide successfully achieved its primary endpoint by conferring a statistically significant reduction in hemoglobin HbA1c and a further secondary endpoint of reduced body weight compared to insulin glargine. Specifically, at 52 weeks, the highest dose of tirzepatide (15mg) resulted in an A1C reduction of 2.58% and an impressive body weight reduction of 11.7 kg compared to patients treated with insulin glargine (1.44% and +1.9kg). The most common side effects for patients treated with tirzepatide were gastrointestinal in nature.

Jesse Cuaron, CVMD and GH Director at GlobalData, comments: Key opinion leaders (KOLs) interviewed by GlobalData were highly impressed after learning about the significant HbA1c and weight reduction following treatment with tirzepatide. Despite the impressive results, they voiced caution in treating certain T2D patients, for example patients with advanced diabetic retinopathy, as this population could actually experience more deterioration in association with too rapid of decline in HbA1c. Overall, KOLs expressed amazement with the multiple clinical trial data sets, including head-to-head trial data, that continue to be released by Eli Lilly, and look forward to additional worldwide clinical trial data to be released.”

Eli Lilly also revealed that tirzepatide was able to demonstrate superiority over Novo Nordisk’s Ozempic (semaglutide) and Tresiba (insulin degludec) in previous trials. Specifically, tirzepatide demonstrated reductions in both HbA1c and weight in T2D patients when compared to the GLP-1RA and second-generation basal insulin. Tirzepatide is also being studied for the treatment of non-alcoholic steatohepatitis (SYNERGY-NASH) and heart failure with preserved ejection fraction and obesity (SUMMIT).

Cuaron adds: “Overall, GlobalData believes that tirzepatide, if approved, will provide physicians and patients with a therapy that could help patients achieve HbA1c levels that are within the normal range for non-diabetic individuals (below 5.7%), while also providing Eli Lilly an edge over primary competitors, like Novo Nordisk. Its novel dual mechanism of action establishes tirzepatide as a first-in class GLP-1/GIP, and a strong contender against competitors in the T2D market.”