An injector pen of Zepbound, Eli Lilly’s weight loss drug, is on display in New York, the United States, December 11, 2023.
Brendan McDermid | Reuters
Elie Lilly said Wednesday that its wildly popular weight loss drug, Zepbound, showed potential to treat patients with the most common sleep-related breathing disorder in two late-stage clinical trials.
The early findings add to the long list of potential health benefits from weight loss and diabetes treatments, demand for which has soared over the past year despite their high prices and insurance coverage. uneven.
Zepbound was more effective than a placebo in reducing the severity of obstructive sleep apnea, or OSA, in obese patients after one year, according to preliminary data from both trials. The pharmaceutical giant said it plans to present the findings at an upcoming medical conference and submit them to the U.S. Food and Drug Administration and regulators in other countries by mid-year.
Eli Lilly previously announced that the FDA had granted Zepbound “fast track designation” for patients with moderate to severe OSA and obesity. This designation expedites review of drugs that treat a serious or life-threatening condition and address an unmet medical need.
The findings are an early sign of hope for the estimated 80 million patients in the United States suffering from OSA, which refers to interrupted breathing during sleep due to narrowing or blockage of the airways. About 20 million of these people have moderate to severe forms of the disease, but 85 percent of OSA cases go undiagnosed, according to Eli Lilly.
OSA can cause excessive daytime sleepiness, loud snoring, and contribute to serious complications including hypertension, stroke, and heart failure. Patients with this condition have limited treatment options aside from bulky and often uncomfortable machines that provide positive airway pressure, or PAP, to allow normal breathing.
“It is critical to address this unmet need head-on, and while there are pharmaceutical treatments for the excessive sleepiness associated with OSA, (Zepbound) has the potential to be the first pharmaceutical treatment for the disease under -jacent,” said Dr. Jeff Emmick, director of Eli Lilly. senior vice president of product development, said Wednesday in a statement.
Zepbound has fallen into a shortage since receiving approval in the United States for weight management in November. The active ingredient in Zepbound, known as tirzepatide, is also approved under the brand name Mounjaro for diabetes.
Results of the first tests
The two phase three trials, both called SURMOUNT-OSA, tested Zepbound in two groups of patients. Notably, 70% of study participants were men.
The researchers specifically looked at how well the weekly injection reduced the so-called apnea-hypopnea index, or AHI, which records the number of times per hour a person’s breathing shows airway restricted or completely blocked. The index is used to assess the severity of obstructive sleep apnea and the effectiveness of treatments for this condition.
In both substudies, Zepbound was superior to placebo in reducing AHI, which was the primary objective of the trials.
The first study evaluated the drug in adults with moderate to severe obstructive sleep apnea and obesity who were not receiving PAP treatment.
Zepbound resulted in an average AHI reduction of 25.3 events per hour at 52 weeks, regardless of whether the patient stopped treatment. This compares to an average reduction of 5.3 events per hour for the placebo.
Zepbound also met the second endpoint of the trial, leading to an overall reduction in AHI of more than 50%, compared to a 3% decrease for placebo. These data included patients who stopped treatment.
The second study tested Zepbound in adults with the same conditions, but these patients were taking and planning to continue PAP treatment.
Eli Lilly’s drug resulted in an average AHI reduction of 29.3 events per hour at 52 weeks, regardless of whether the patient stopped treatment. This compares to an average reduction of 5.5 events per hour for the placebo.
Zepbound resulted in an overall reduction in AHI of almost 59%, compared to a decrease of more than 2% for placebo, which included data from patients who stopped treatment.
In both studies, Zepbound helped patients lose about 20% of their weight. But Eli Lilly noted that men are known to lose less weight than women through therapies like Zepbound.
Eli Lilly’s Zepbound works by mimicking two naturally produced gut hormones called GLP-1 and GIP. GLP helps reduce food consumption and appetite. GIP, which also suppresses appetite, may also improve how the body breaks down sugar and fat.
Notably, Eli Lilly’s main rival Novo Nordisk is not studying its own medications for weight loss and diabetes in patients with sleep apnea.
cnbc
