*

Mounjaro reduces major heart problems by 8% versus

Trulicity in

trial

*

Death from any cause was 16% lower for patients on

Mounjaro

versus Trulicity

*

Safety profile similar for both drugs

(Adds trial detail, paragraph 4, shares and analyst comment in

paragraph 5, cardiologist comment, paragraph 6)

By Patrick Wingrove

July 31 (Reuters) - Eli Lilly ( LLY ) said on Thursday

that its newer diabetes drug Mounjaro outperformed Trulicity,

its previously top-selling medication for the disease, in

reducing the risk of heart attack and stroke in a large,

head-to-head study.

In the Lilly-funded trial of more than 13,000 patients with

type 2 diabetes and high cardiovascular risk, Mounjaro reduced

the risk of major adverse heart events by 8% more than

Trulicity, the Indianapolis-based drugmaker said.

The risk of death from any cause was 16% lower for Mounjaro

patients than for those taking Trulicity, though researchers are

still studying the data to understand what is behind the

difference.

Mounjaro achieved the main goal of the trial, which was

non-inferiority versus Trulicity for heart protection, the

company said, adding that it also led to greater blood sugar

control and weight loss.

Lilly shares dipped 0.5% in early trading. BMO analyst Evan

Seigerman said in a note that although the trial results

showcased Mounjaro's strengths, a significant contingent of

investors had been betting it would show clear superiority.

Stanford cardiologist Dr. Chad Weldy said the new data may

prompt him to recommend switching from Trulicity to Mounjaro, at

least for patients with type 2 diabetes and obesity or heart

issues. Still, he emphasized that insurance, patient

preferences, and tolerability will guide final decisions.

Mounjaro is the company's diabetes drug that targets the

GLP-1 protein and is also used for weight loss. In the U.S., the

obesity version is sold under the brand name Zepbound.

Trulicity, which first won U.S. approval in 2014, has been a

go-to treatment for preventing heart disease in people with

diabetes since the Food and Drug Administration approved it for

that use in 2020 following data showing a 12% reduction in

heart-related risk.

Once Lilly's top seller, Trulicity hit peak sales of $7.4

billion in 2022, aided by the added heart-related approval,

according to the company. Mounjaro stole that mantle last year

with $11.5 billion in sales, more than double Trulicity's $5.2

billion.

Kenneth Custer, president of Lilly's cardiometabolic health

division, told Reuters that the new results make Mounjaro an

even stronger choice for patients.

The new late-stage study, which spanned nearly five years,

was the largest and longest trial yet for tirzepatide - the

chemical name for Mounjaro - Lilly said. Custer said the company

planned to submit its findings to the FDA later this year for an

anticipated 2026 expanded approval.

The company and Danish rival Novo Nordisk have

been racing for more than two years to prove their competing

GLP-1 drugs, already shown to be powerful weight loss agents and

diabetes treatments, can also be used to tackle other major

diseases and potentially expand insurance coverage.

Lilly has a similar study underway testing Zepbound as a

treatment for heart disease in obese patients. The FDA approved

Novo's rival drug Wegovy to treat heart disease in obese

patients in March 2024.

Zepbound has already been shown to reduce the risk of

hospitalization, death and other adverse outcomes in a smaller

study of obese adults with a common type of heart failure,

although the FDA has yet to approve the drug for that

indication.

In diabetes care versus Novo's Ozempic, Mounjaro has

captured more than half of the U.S. market share, according to

IQVIA data shared with Reuters by an analyst.

Mounjaro and Trulicity had similar safety profiles in the

trial, with most side effects being mild-to-moderate stomach

issues that usually resolved after increasing the dose, Lilly

said.

The GLP-1 drugs are known to cause gastrointestinal issues

and more participants stopped taking Mounjaro due to side

effects (13.3%) than Trulicity (10.2%).