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Lilly starts large-scale trial of tirzepatide in diabetic heart disease

Trial compares drug to Trulicitiy

Eli Lilly

Eli Lilly has started dosing patients with tirzepatide in a high-stakes trial that will compare the drug to Trulicity, its top-selling drug.

The SURPASS-CVOT will have 12,500 patients with type 2 diabetes and established atherosclerotic cardiovascular disease when fully enrolled, and will see if tirzepatide can match or improve on Trulicity (dulaglutide) in reducing cardiovascular death, myocardial infarction or stroke.

GLP-1 agonist Trulicity brought in $4.1bn in sales for Lilly last year and consolidated its position as the company’s biggest product with another 40% increase in the first three months of this year to $1.2bn.

The size of trial makes it a big investment for Lilly, and a bit of a gamble which could cost upwards of $2bn to run, according to EvaluatePharma, which notes that Lilly’s REWIND trial of Trulicity in this setting involved less than 10,000 patients and cost an estimated $1.9bn.

Tirzepatide is a combined GIP/GLP-1 agonist that Lilly thinks could improve on Trulicity – and other rivals in the GLp-1 class like Novo Nordisk’s Ozempic (semaglutide). It is testing that hypothesis in type 2 diabetics in the ongoing SURPASS trial, which should generate results later this year.

The trial will take four years to complete, so with an end-date due in 2024, just three years before Trulicity stands to lose patent protection, Lilly undoubtedly thinks it is a gamble worth taking.

“Lilly is making a bold move by comparing tirzepatide to Trulicity, which is already proven to significantly reduce the risk of major adverse cardiovascular events,” said SURPASS-CVOT co-chairs David D'Alessio of Duke University School of Medicine and Stephen Nicholls of Monash University Victorian Heart Institute in a statement.

Improving cardiovascular outcomes in diabetic patients is just one objective in Lilly’s tirzepatide development programme, however, and the company is also running trials of the drug in obesity (SURMOUNT) and non-alcoholic steatohepatitis or NASH (SYNERGY) that if positive could dramatically increase its revenue potential. All told, its trials for the drug include more than 20,000 patients.

GIP and GLP-1 are hormones which are both secreted from the intestine to stimulate insulin secretion in response to ingested food.

Last year, Lilly reported results from a phase 2 trial showing that tirzepatide was better at reducing blood sugar levels and body weight than Trulicity.

Article by
Phil Taylor

11th June 2020

From: Research

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