Eli Lilly’s much-anticipated tirzepatide, a once-weekly dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 receptor agonist (GLP-1RA), recently showed that it was not limited to HbA1c levels in type 2 – Can reduce diabetes (T2D) patients, but also weight loss compared to insulin glargine in the SURPASS-4 study. Tirzepatid has the potential to achieve blockbuster status if approved by helping fight the growing T2D epidemic, causing significant weight loss, and continuing to outperform established giants in direct clinical trials, says GlobalData, a data leader and analytics company.
SURPASS-4 is a randomized (2,002 subjects), parallel, open-label phase III clinical trial investigating treatment with tirzepatide (5 mg, 10 mg and 15 mg) compared to insulin glargine in adult T2D patients who had an increased Are at risk for cardiovascular disease and are inadequately controlled with oral T2D drugs.
Tirzepatid successfully met its primary endpoint with a statistically significant decrease in hemoglobin HbA1c and a further secondary endpoint of weight reduction compared to insulin glargine. In particular, the highest dose of tirzepatide (15 mg) after 52 weeks resulted in a 2.58% reduction in A1C and an impressive 11.7 kg reduction in body weight compared to patients treated with insulin glargine (1.44% and +1.9 kg). The most common side effects in 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 very impressed after learning of the significant HbA1c and weight reductions after treatment with Tirzepatid. Despite the impressive results, they expressed caution in the treatment of certain T2D patients, such as those with advanced diabetic retinopathy, as this population may actually experience greater deterioration in conjunction with a too rapid drop in HbA1c. Overall, KOLs were amazed at the numerous clinical trial data sets, including direct trial data, which will continue to be published by Eli Lilly, and look forward to further global clinical trial data release. ‘
Eli Lilly also announced that tirzepatid was superior to Ozempic (semaglutide) and Tresiba (insulin degludec) from Novo Nordisk in previous studies. In particular, tirzepatide showed reductions in both HbA1c and weight compared to GLP-1RA and second generation basal insulin in T2D patients. Tirzepatid is also being studied for the treatment of non-alcoholic steatohepatitis (SYNERGY-NASH) and congestive heart failure with preserved ejection fraction and obesity (SUMMIT).
Cuaron adds: ‘Overall, GlobalData believes that if approved, tirzepatide will provide physicians and patients with therapy that could help patients achieve HbA1c levels that are within the normal range for non-diabetics (below 5, 7%), and at the same time Eli Lilly has an advantage over main competitors such as Novo Nordisk. Its novel dual mechanism of action makes Tirzepatid a top-notch GLP-1 / GIP and a strong competitor in the T2D market. ‘
