An injection pen of Zepbound, Eli Lilly’s weight loss drug, is displayed on December 11, 2023 in New York City, United States.
Brendan McDermid | Reuters
Eli Lilly said Tuesday that its wildly popular weight-loss and diabetes drug showed promising results in treating fatty liver disease in a medium-sized trial.
The initial study results add to a long list of potential health benefits of the treatment known as tirzepatide, helping patients lose significant pounds and regulate blood sugar levels under the brand names Zepbound and Mounjaro, respectively. These additional benefits could potentially expand limited insurance coverage for weight-loss medications, 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 2 trial to treat a severe form of liver disease, metabolic dysfunction-associated steatohepatitis (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, MASH affects an estimated 3 to 5% of adults in the United States.
The study included about 190 adults with MASH and severe liver scarring, Eli Lilly executives said in a results conference call Tuesday.
At all doses, tirzepatide achieved the study’s primary goal of relieving patients of disease without worsening liver scarring compared to people who did not receive the treatment, the company said in its results presentation.
For example, about 74% of patients who received the highest dose of tirzepatide, 15 milligrams, were free of MASH after one year without worsening liver scars, compared to about 13% of those who received a placebo.
It was less clear to what extent the drug reduced liver scarring, which was the study’s second aim. Eli Lilly did not disclose whether tirzepatide met that goal, but the company said the drug’s effect on reducing liver scarring was “clinically meaningful” at all dosage 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 dire in the data that would stop us from moving forward to phase three,” he added. “I think the fact that we have a positive phase 2 study here with really strong data in MASH forces us to 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 studies with Zepbound showed that patients experienced diarrhea, nausea, and vomiting, among other symptoms.
Eli Lilly will present the full results of the Phase 2 trial at a medical conference later this year.
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Leerink Partners analyst David Risinger called the initial trial results “positive” in a research note on Tuesday. He said a larger and longer Phase III trial could increase the likelihood that tirzepatide results in 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 thought to slow stomach emptying, allowing people to feel full longer and suppressing appetite by slowing hunger signals in the brain.
Several other drugmakers are trying to develop treatments for MASH.
This includes Eli Lilly’s main rival Novo Nordisk, which is studying semaglutide, also known as Wegovy for weight loss and Ozempic for treating diabetes, in a late-stage study in MASH. However, a medium-term study 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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2024-02-06 18:40:54
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