A Zepbound injection pen, Eli Lilly’s weight loss drug, is seen in New York, U.S., December 11, 2023.
Brendan McDermid | Reuters
Eli Lilly on Tuesday said that the extremely popular drug used for weight loss and diabetes showed promise as a treatment for fatty liver disease in a trial in the middle.
The initial study results add to a long list of potential health benefits for the treatment, known as tirzepatide, in addition to helping patients lose significant weight and regulate blood sugar under the drug’s brand names, Zepbound and Mounjaro. respectively. These added benefits could potentially extend limited insurance coverage for weight loss drugs, most of which cost close to $1,000 a month.
The pharmaceutical giant said in its fourth-quarter earnings call 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 drugs 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. One estimated 3% to 5% of US adults are affected by MASH, according to some studies.
The trial followed about 190 MASH adults with severe stages of liver scarring, Eli Lilly executives said in an earnings call Tuesday.
At all dose sizes, tirzepatide met the trial’s primary goal of helping patients clear the disease without worsening liver scarring compared with people who didn’t receive the treatment, according to the company’s earnings presentation.
For example, about 74% of patients who received the highest 15-milligram dose of tirzepatide were free of MASH without worsening liver scarring after one year, compared with about 13% of those who received placebo.
It was less clear how much 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 going to phase three,” he added. “I think the positive phase two trial here with really important data in MASH compels us to think about next steps.”
He noted that the side effects were consistent with other studies of tirzepatide in patients with obesity and diabetes, without providing further details. Previous tests in Zepbound showed that patients experienced diarrhea, nausea, and vomiting, among other symptoms.
Eli Lilly will present full results from the second phase of the trial at a medical conference later this year.
Leerink Partners analyst David Risinger called the initial test results “positive” in a research note on Tuesday. He said a larger and larger phase III study could increase the chances of tirzepatide causing a statistically significant reduction in liver scarring.
Tirzepatide works by activating two naturally produced hormones 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 fuller for longer, and to suppress appetite by slowing hunger signals to the brain.
Several other pharmacists are trying to develop treatments for MASH.
They include Eli Lilly’s main rival Novo 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 resultsaccording to data released in 2022.
Unlike tirzepatide, semaglutide targets only GLP-1.
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