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

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

Tirzepatide showed positive results in a phase 2 trial as a treatment for a serious form of liver disease called metabolic dysregulation-associated steatohepatitis, or MASH, the pharmaceutical giant said in its fourth-quarter earnings statement.

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

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

Across all dose sizes, tirzepatide met the trial’s primary goal of helping patients become disease-free without worsening liver scarring compared with people who did not receive the treatment, according to the company’s earnings presentation.

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

It was not clear how much the drug affected liver scarring, which was the second goal of the trial. Eli Lilly did not disclose whether tirzepatide achieved this goal, but the company said the drug’s effect on reducing liver scarring was “clinically meaningful” at all dose sizes.

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

He added: “There is nothing bad in the data that would prevent us from moving to phase three.” “I think having a positive phase 2 trial here with really useful data in MASH compels us to think about next steps.”

He noted that the adverse events were consistent with other studies conducted on the drug terzepatide in patients with obesity and diabetes, without providing further details. Previous trials with Zepbound showed that patients experienced diarrhea, nausea and vomiting, among other symptoms.

Eli Lilly will present full results from the Phase 2 trial at a medical conference later this year.

David Reisinger, an analyst at Leerink Partners, described the initial trial results as “positive” in a research note on Tuesday. A larger, longer phase 3 study could increase the odds that tirzepatide causes a statistically significant reduction in liver scarring, he said.

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

This combination is said to slow stomach emptying, making people feel full longer and suppress appetite by slowing hunger signals in the brain.

Several other drug makers are trying to develop treatments for MASH.

They include Novo Nordisk, Eli Lilly’s main competitor, which is studying semaglutide, also known as Wegovy for weight loss and Ozempic for treating diabetes, in a late-stage trial in MASH. But a mid-stage trial of semaglutide in MASH patients had mixed results, according to data released in 2022.

Unlike tirzepatide, semaglutide targets GLP-1 only.

(tags for translation) Breaking News

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