Lilly's Trulicity diabetes drug cuts risk of CV events in lower-risk patient group

Eli Lilly has scored a major victory in its battle for the US diabetes drug market after a trial showed its Trulicity cut risk of cardiovascular events, even in patients who had no prior history of such problems.

A glucagon-like peptide (GLP-1) agonist class drug, Trulicity (dulaglutide) is under threat in the US from Novo Nordisk’s Ozempic (semaglutide), which can also be taken weekly and until now has had an edge in clinical trial results.

Trulicity is Lilly’s top selling drug and helped to drive an increase in revenues in third quarter results just announced by the company – income in this quarter at the end of September more than doubled to $1.15 billion compared with the same period last year.

And latest results from the REWIND trial show Trulicity can do something not seen with Ozempic – it reduced risk of cardiovascular (CV) death, and non-fatal heart attacks and strokes in a 9,901-patient trial population where the majority of participants did not have established cardiovascular disease.

Lilly's trial was the first cardiovascular trial of a diabetes drug involving such a diverse patient population, as previous trials such as those involving Boehringer Ingelheim’s Jardiance (empagliflozin) and Ozempic have only focused on high-risk patients who had already had a CV incident.

For years the FDA has required pharma companies to carry out safety studies to ensure diabetes drugs do not increase risks of CV events – but pharma has turned the requirement to its advantage and started designing trials to test whether drugs can reduce likelihood of such events.

Hertzel Gerstein, professor of medicine and deputy director of the Population Health Institute at McMaster University and Hamilton Health Sciences and REWIND study chair, said: “The REWIND study was ambitious, assessing whether Trulicity could protect people with type 2 diabetes from experiencing an initial cardiovascular event, and prevent future events in those who have established cardiovascular disease.

“The MACE reduction demonstrated by Trulicity, across a broad range of people with type 2 diabetes, is compelling and we look forward to analysing and reporting all of the data.”

Lilly pointed out that REWIND also had a follow-up period of more than five years, the longest for a CV outcome trial in the GLP-1 class.

Ozempic showed a small benefit in CV events in a safety trial but results were not strong enough for Novo Nordisk to ask for an extension to the drug’s indication, although the findings can be mentioned on the label.

Novo is also developing an oral version of semaglutide that could prove popular with patients if approved as it will cut the amount of injections they require, and is expecting results from a CV outcomes trial in the coming weeks.

But the likelihood is that the Danish drug firm will have to conduct a further, much larger trial as PIONEER 6 is small for a CV outcomes trial and the company has admitted the likelihood is that it will not show a benefit.

Lilly will submit the latest data to regulators and share detailed results at next year’s American Diabetes Association conference.