Eli Lilly’s weight loss drug may treat fatty liver disease

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An injection pen of Zepbound, Eli Lilly’s weight loss drug, is displayed in New York City, US, 11 December 2023.

Brendan McDermid | Reuters

Eli Lilly On Tuesday it said its popular drug for weight loss and diabetes showed promise as a treatment for fatty liver disease in a middle-aged trial.

The results of the initial study add to a long list of potential health benefits of the treatment, called tirzepatide, in addition to helping patients lose significant pounds and manage blood sugar under the brand names of the drug, Zepbound and Mounjaro, respectively. These additional benefits could extend the limited insurance coverage for weight loss drugs, most of which cost nearly $1,000 per month.

The pharmaceutical giant said in its fourth-quarter earnings release that tirzepatide showed positive results in a phase two trial as a treatment for a severe form of liver disease called metabolic dysfunction-associated steatohepatitis, or MASH.

There are currently no treatments or medications available to directly treat MASH. The condition is characterized by excess fat and inflammation in the liver and can lead to scarring of the liver, also known as fibrosis. It is estimated that 3% to 5% of adults in the US are affected by MASH, according to some studies.

The trial followed about 190 adults with MASH with severe degrees of liver scarring, Eli Lilly officials said on an earnings call Tuesday.

At all dose levels, tirzepatide met the trial’s primary goal of helping patients become disease-free without worsening liver scarring compared to people who didn’t receive the treatment, according to the company’s earnings presentation.

For example, about 74% of patients who received the highest tirzepatide dose of 15 milligrams became free of MASH without worsening liver scarring after one year, compared to about 13% of the those who received a placebo.

It was not so clear how much the drug reduced liver scarring, which was the second goal of the trial. Eli Lilly did not say whether tirzepatide met that goal, but the company said the drug’s effect on reducing liver scarring was “clinically meaningful” across all dose sizes.

Eli Lilly is “equally encouraged” by tirzepatide’s results in reducing liver scarring, the company’s chief scientific officer, Dan Skovronsky, said on the call.

“There’s nothing bad in the data that would stop us from going to phase three,” he said. “I think there’s an advanced phase two trial here with very meaningful data in MASH let’s think about the next steps.”

He noted that adverse events were consistent with other studies of tirzepatide in patients with obesity and diabetes, without providing further details. Previous tests on Zepbound showed that patients experienced diarrhea, nausea and vomiting, among other symptoms.

Eli Lilly will present the full results of the phase two trial at a medical conference later this year.

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Leerink Partners analyst David Risinger called the initial test results “positive” in a research note on Tuesday. He said a larger and longer phase three study could increase the chances of tirzepatide causing a statistically significant reduction in liver scarring.

Tirzepatide works by activating two naturally occurring hormones in the body: glucagon-like peptide-1, called GLP-1, and glucose-dependent insulinotropic polypeptide, or GIP.

The combination is said to slow stomach emptying, making people feel fuller for longer and curbing appetite by slowing hunger signals in the brain.

Several other drugmakers are trying to develop treatments for MASH.

Among them is major competitor Eli Lilly New Nordisk, which is studying semaglutide, also known as Wegovy for weight loss and Ozempic for diabetes, in a late-stage trial in MASH. But a mid-term trial of semaglutide in MASH patients had mixed results, according to data published in 2022.

Unlike tirzepatide, semaglutide only targets GLP-1.

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