An injection pen of Zepbound, Eli Lilly’s weight loss drug, is displayed in Latest York City, U.S., December 11, 2023.
Brendan McDermid | Reuters
Eli Lilly on Tuesday said its highly popular drug used for weight loss and diabetes showed promise as a treatment for fatty liver disease in a midstage trial.
The initial study results add to a protracted list of potential health advantages of the treatment, often known as tirzepatide, besides helping patients shed significant kilos and regulate blood sugar under the drug’s brand names, Zepbound and Mounjaro, respectively. Those additional advantages could potentially expand the limited insurance coverage for weight loss drugs, most of which cost near $1,000 per 30 days.
The pharmaceutical giant said in its fourth-quarter earnings release that tirzepatide showed positive leads to a phase two trial as a treatment for a serious type of liver disease called metabolic dysfunction-associated steatohepatitis, or MASH.
There are currently no cures or medicines available to directly treat MASH. The condition is characterised by excess fat buildup and inflammation within the liver and may result in liver scarring, also often known as fibrosis. An estimated 3% to five% of adults within the U.S. are affected by MASH, in line with some studies.
The trial followed around 190 adults with MASH with severe stages of liver scarring, Eli Lilly executives said on an earnings call Tuesday.
In any respect dose sizes, tirzepatide met the trial’s foremost goal of helping patients turn into freed from the disease with no worsening of liver scarring compared with individuals who didn’t receive the treatment, in line with the corporate’s earnings presentation.
For instance, around 74% of patients who received the very best tirzepatide dose of 15 milligrams became freed from MASH with no worsening of liver scarring after a 12 months, compared with around 13% of those that received a placebo.
It was less clear how much the drug reduced liver scarring, which was the second aim of the trial. Eli Lilly didn’t disclose whether tirzepatide met that goal, but the corporate said the drug’s effect on decreasing liver scarring was “clinically meaningful” across all dose sizes.
Eli Lilly is “equally encouraged” by tirzepatide’s leads to reducing liver scarring, the corporate’s chief scientific officer, Dan Skovronsky, said on the decision.
“There’s nothing bad in the information that may stop us from going to phase three,” he added. “I believe having a positive phase two trial here with really meaningful data in MASH obligates us to take into consideration next steps.”
He noted that opposed events were consistent with other studies on tirzepatide in patients with obesity and diabetes, without providing further details. Previous trials on Zepbound showed that patients experienced diarrhea, nausea and vomiting, amongst other symptoms.
Eli Lilly will present the total results from the phase two trial at a medical conference later this 12 months.
Leerink Partners analyst David Risinger called the initial trial results “positive” in a research note Tuesday. He said a bigger and longer phase three study could increase the chances of tirzepatide causing a statistically significant decrease in liver scarring.
Tirzepatide works by activating two naturally produced hormones within the body: glucagon-like peptide-1, often known as GLP-1, and glucose-dependent insulinotropic polypeptide, or GIP.
The mix is claimed to slow the emptying of the stomach, making people feel full for longer and suppressing appetite by slowing hunger signals within the brain.
Several other drugmakers are attempting to develop treatments for MASH.
They include Eli Lilly’s foremost rival Novo Nordisk, which is studying semaglutide, also often known as Wegovy for weight loss and Ozempic for diabetes, in a late-stage trial in MASH. But a midstage trial on semaglutide in MASH patients had mixed results, in line with data released in 2022.
Unlike tirzepatide, semaglutide only targets GLP-1.
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