Eli Lilly on Thursday reported data from the latest Phase III trial to readout from the SURPASS programme, showing that its once-weekly GIP/GLP-1 receptor agonist tirzepatide was superior to Novo Nordisk's Ozempic (semaglutide) at helping adults with type 2 diabetes lower their blood glucose levels and lose weight. Mike Mason, president of Lilly's diabetes unit, said "these striking head-to-head results surpassed our expectations, supporting our belief in the value of all three doses of tirzepatide as potential new treatment options."
Data from the SURPASS-2 trial build on similar benefits seen with tirzepatide in SURPASS-1, and more recently in SURPASS-3 and SURPASS-5 as well. SURPASS-2 randomised 1879 patients with type 2 diabetes to receive one of three doses of tirzepatide or Ozempic as an add-on to metformin for 40 weeks. Baseline values for HbA1c and weight were 8.28% and 93.7 kg, respectively, and participants had been diagnosed with diabetes for an average of 8.6 years.
Top-line results using the efficacy estimand showed that participants on the highest tirzepatide dose of 15 mg achieved a HbA1c reduction of 2.46% and weight loss of 12.4 kg, or 13.1%, from baseline to 40 weeks. The corresponding values for Ozempic were a decrease of 1.86% in HbA1c, while patients lost 6.2 kg, or 6.7% of their body weight, half that seen with Eli Lilly's drug. In addition, 92.2% of patients receiving tirzepatide 15 mg achieved HbA1c of <7% and 50.9% reached a target of <5.7%. That compares to rates of 81.1% and 19.7%, respectively, for the Ozempic arm.
Meanwhile, in the group receiving tirzepatide 10 mg, results demonstrated that HbA1c fell 2.37% and patients lost 10.3 kg, or 11% of their body weight, with 88.9% of subjects hitting the <7% HbA1c target. At the 5-mg dose level, patients had HbA1c and body weight reductions of 2.09% and 7.8 kg, respectively, both significantly greater than Ozempic, while 85.5% achieved HbA1c levels of <7%.
"These results show that all three doses of tirzepatide delivered superior HbA1c and weight reductions compared to the highest approved dose of semaglutide to treat type 2 diabetes," remarked principal investigator Juan Pablo Frías. He added that "newer treatment options may help [patients] achieve their HbA1c and weight-loss goals," and in the SURPASS-2 trial, tirzepatide delivered efficacy that went "beyond what has been seen with an existing medicine in the established GLP-1 receptor agonist class."
The overall safety profile of tirzepatide was similar to previously reported SURPASS trials. Eli Lilly said rates of hypoglycaemia <54 mg/dL ranged from 0.2% to 1.7% among tirzepatide-treated patients, depending on the dose, and was 0.4% among subjects who received Ozempic. The most commonly reported adverse events across all treatment arms were gastrointestinal-related, and involved nausea, diarrhoea and vomiting. Treatment discontinuation rates ranged from 5.1% to 7.9% for tirzepatide, versus 3.8% for Ozempic. Eli Lilly said complete results from SURPASS-2 will be presented at the American Diabetes Association (ADA) annual meeting and published in a peer-reviewed publication this year. For more insight on the SURPASS-2 data, see ViewPoints: Tirzepatide delivers most compelling data yet.
Meanwhile, the company is also running the Phase III SURPASS-CVOT cardiovascular (CV) outcomes study that got under way last year to assess tirzepatide head-to-head against its GLP-1 receptor agonist Trulicity (dulaglutide), whose US label includes reducing CV events in adults with type 2 diabetes.
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