An injectable pen of Zepbound, Eli Lilly's weight loss drug, is displayed in New York City, U.S., on December 11, 2023.
Brendan McDermid | Reuters
Eli Lilly on Tuesday said its wildly popular drug used for weight loss and diabetes showed promise as a treatment for fatty liver disease in a mid-stage trial.
The study's initial results add to a long list of potential health benefits of the treatment, known as tirzepatide, in addition to helping patients lose pounds and regulate blood sugar under the drug's brand names, Zepbound and Mounjaro. , respectively. Those additional benefits could potentially expand limited insurance coverage for weight-loss medications, most of which cost about $1,000 a month.
The pharmaceutical giant said in its fourth-quarter earnings report that tirzepatide showed positive results in a phase two trial as a treatment for a severe form of liver disease called steatohepatitis associated with metabolic dysfunction, or MASH.
There are currently no cures or medications available to directly treat MASH. The condition is characterized by excessive fat accumulation and inflammation in the liver and can lead to liver scarring, also known as fibrosis. According to some studies, an estimated 3% to 5% of adults in the US are affected by MASH.
The trial followed about 190 adults with MASH with severe stages of liver scarring, Eli Lilly executives said in an results conference call Tuesday.
At all dose sizes, tirzepatide met the trial's primary goal of helping patients become disease-free without worsening liver scarring compared to people who did not 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 stopped receiving MASH without worsening liver scarring after a year, compared with about 13% of those who received a placebo.
It was less clear to what extent the drug reduced liver scarring, which was the second goal of the trial. Eli Lilly did not disclose whether tirzepatide met that goal, but the company said the drug's effect on reducing liver scarring was “clinically significant” at 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 is nothing wrong with the data that would prevent us from moving to phase three,” he added. “I think having a positive phase two trial here with really significant data in MASH forces us to think about next steps.”
It noted that the adverse events were consistent with other studies of tirzepatide 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 two trial at a medical conference later this year.
Leerink Partners analyst David Risinger called the initial trial results “positive” in a research note on Tuesday. He said a larger, longer phase three study could increase the chances that tirzepatide will cause a statistically significant decrease in liver healing.
Tirzepatide works by activating two hormones produced naturally in the body: glucagon-like peptide 1, known as GLP-1, and glucose-dependent insulinotropic polypeptide, or GIP.
The combination is said to slow stomach emptying, making people feel full longer and suppressing appetite by slowing hunger signals in the brain.
Several other drug manufacturers are trying to develop treatments for MASH.
They include Eli Lilly's main rival Nordisk, which is studying semaglutide, also known as Wegovy for weight loss and Ozempic for diabetes, in a late-stage trial at MASH. But a mid-stage trial of semaglutide in patients with MASH had mixed results, according to data published in 2022.
Unlike tirzepatide, semaglutide only targets GLP-1.
