Eli Lilly’s Mounjaro shows similar heart health advantages as Trulicity

Eli Lilly on Thursday said its blockbuster diabetes drug Mounjaro showed heart health advantages in a late-stage trial directly comparing it to the corporate’s older diabetes treatment, Trulicity.

Mounjaro met the study’s major goal of showing that it wasn’t any worse than Trulicity at treating individuals with Type 2 diabetes and established heart problems. Eli Lilly said it believes the brand new data bolsters the case for Mounjaro to be prescribers’ first alternative for patients with Type 2 diabetes, who’re twice as more likely to have heart disease or stroke as those without the disease.

The outcomes come as Trulicity – also a top-selling drug for Eli Lilly – faces a patent expiration in 2027, which could further boost Mounjaro’s position within the diabetes market. 

Mounjaro met the major goal of the nearly five-year study, reducing the chance of cardiovascular death, heart attack or stroke by 8% when in comparison with Trulicity in adults with Type 2 diabetes and heart problems. But the outcomes didn’t meet some analysts’ benchmarks for being considered superior to Trulicity. 

Still, the corporate said Mounjaro showed additional, “more comprehensive” advantages over Trulicity within the trial, including a 16% lower rate of death from any cause and greater kidney protection. It was the longest and largest trial to this point on tirzepatide, the energetic ingredient in Mounjaro, enrolling greater than 13,000 people. 

Some clinicians said the outcomes, particularly the lowered risk of cardiovascular events, aren’t surprising, as they assumed Mounjaro would have the ability to supply cardiovascular advantages.

However the difference in the speed of death from any cause between Mounjaro and Trulicity is “really quite profound” and “definitely something clinically meaningful to us as clinicians,” said Dr. David Broome, clinical assistant professor on the department of internal medicine’s metabolism, endocrinology and diabetes division on the University of Michigan.

He said the info helped quantify the difference between Mounjaro and Trulicity, which can further help providers and patients determine the most effective treatment to maneuver forward with of their shared decision-making. Broome said those prescribing decisions between patients and providers will ultimately rely on several aspects, reminiscent of their insurance coverage, the unintended effects of a given drug and the way well the patient tolerates them.

Dr. Howard Weintraub, clinical director of the Center for the Prevention of Cardiovascular Disease at NYU Langone Heart, called Mounjaro a “winner” within the trial, with the one downside coming from it having barely more unintended effects than Trulicity. But he said the outcomes may not motivate more people to begin Mounjaro, and that the drug’s higher list price may deter insurers from covering it if it is not substantially higher than Trulicity.

Weintraub said he expects there to be loads of “digging” into the info when the total results are presented at a European medical meeting and published in a peer-reviewed journal in the autumn.

Eli Lilly saw the trial results as an indicator that clinicians should select Mounjaro for the patient group.

“It strengthens the general story. In my mind, it raises the query of, ‘Why would not you select Mounjaro?'” Ken Custer, president of Lilly Cardiometabolic Health, said in an interview. 

The outcomes “take away any doubt of why that is the precise medicine for a patient with Type 2 diabetes and Type 2 diabetes with cardiovascular risk,” he said, adding that it “makes it even harder to say no to covering this medicine for patients.”

The outcomes also come as Eli Lilly solidifies its lead over Novo Nordisk within the booming marketplace for weight reduction and diabetes drugs. Studies from each firms have shown the added health advantages of their drugs for conditions reminiscent of obstructive sleep apnea and chronic kidney disease. 

Eli Lilly plans to submit the guts health data to global regulators by the tip of the yr, and the corporate said that may lead to approvals — and by extension insurance coverage — of Mounjaro for this purpose in 2026. Any approvals wouldn’t apply to Eli Lilly’s weight reduction drug Zepbound, which shares the identical energetic ingredient as Mounjaro but is specifically cleared for patients with obesity and never diabetes. 

The corporate is currently studying Zepbound’s cardiovascular advantages in patients with obesity and established heart problems. The phase three trial is anticipated to wrap up in 2027, in line with Eli Lilly’s website. 

Even when regulators approve Mounjaro for treating heart disease in patients with Type 2 diabetes, it might not significantly expand use of the drug. That is because Mounjaro’s current approval for Type 2 diabetes already covers a lot of those patients: Around 30% of individuals with Type 2 diabetes even have heart problems, in line with the Heart Foundation. 

In a June research note ahead of the info, TD Cowen analyst Steve Scala said he believes uptake of tirzeptide “can be largely unaffected” if it shows similar heart health advantages as Trulicity. 

Tirzepatide is already “gaining significant adoption” available in the market as a result of its “strong profile,” Leerink Partners analyst David Risinger said in a separate note in June. He said experts agreed that no matter whether tirzepatide’s cardiovascular advantages were superior or matched those of Trulicity within the study, the outcomes “wouldn’t significantly alter” the choices of doctors. 

Mounjaro showed greater improvements than Trulicity did when it got here to some cardiovascular measures and lowering body weight and A1C, which is a measure of blood sugar levels.

The protection data of each Mounjaro and Trulicity were generally consistent with what has been observed prior to now. Probably the most commonly reported adversarial events for each drugs were gastrointestinal-related and customarily mild to moderate in severity. 

— CNBC’s Angelica Peebles contributed to this report.