The injection pen of Eli Lilly and Company’s weight loss drug Zepbound is on display in New York City, the United States, on December 11, 2023.
Brendan McDermid | Reuters
Eli Lilly and Company Its popular weight-loss drug Zepbound shows potential in treating patients with the most common disease, it said on Wednesday sleep-related breathing disorders in two late-stage clinical trials.
Preliminary results add to the long list of potential health benefits of weight loss and diabetes treatments, which have seen demand soar in the last year despite high prices and spotty insurance coverage.
Zepbound is more effective than placebo in reducing symptom severity obstructive sleep apneaAccording to preliminary data from both trials, obese patients develop symptoms of OSA after one year. 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 regulatory agencies in other countries by mid-year.
Eli Lilly and Company previously announced that the FDA granted Zepbound “Fast Track Designation” Suitable for patients with moderate to severe OSA and obesity. This designation expedites the review of drugs that treat serious or life-threatening conditions and address an unmet medical need.
The results are an early sign of hope for the approximately 80 million patients in the United States who suffer from OSA, a disorder in which breathing is interrupted during sleep due to narrowing or obstruction of the airways. According to Eli Lilly and Company, approximately 20 million of these people have moderate to severe OSA disease, but 85% of OSA cases go undiagnosed.
OSA can cause excessive daytime sleepiness, Loud snoring can lead to serious complications, including high blood pressure, stroke, and heart failure.In addition to being troublesome and often uncomfortable, patients with this disease have limited treatment options machine Provide positive airway pressure (PAP) to achieve normal breathing.
“It is critical to address this unmet need head-on, and while there are drugs to treat the excessive sleepiness associated with OSA, (Zepbound) has the potential to be the first drug treatment to target the underlying disease,” said Dr. Jeff Emmick of Eli Lilly and Company. explain.
Zepbound has been hit by shortages since it was approved for weight management in the United States last November. The active ingredient in Zepbound is called tirzepatide, which is also approved under the brand name Mounjaro for the treatment of diabetes.
Preliminary test results
The two Phase 3 trials, both called SURMOUNT-OSA, tested Zepbound in two groups of patients. Notably, 70% of participants in all studies were male.
The researchers specifically examined how much weekly injections reduced so-called apnea-hypopnea index, or AHI, records the number of times per hour a person’s breaths show restriction or complete obstruction of the airway. This index is used to assess the severity of obstructive sleep apnea and the effectiveness of treatments for the condition.
In both substudies, Zepbound was superior to placebo in reducing AHI, the primary target of the trial.
The first study evaluated the drug in adults with moderate to severe obstructive sleep apnea and obesity who were not receiving PAP treatment.
Zepbound reduced an average of 25.3 AHI events per hour at 52 weeks, regardless of whether patients discontinued treatment. In comparison, the placebo group experienced an average of 5.3 fewer events per hour.
Zepbound also achieved the trial’s second goal, reducing overall AHI by more than 50%, compared with a 3% reduction for placebo. This data includes patients who discontinued treatment.
The second study tested Zepbound in adults with the same condition, but who were receiving and planning to continue PAP treatment.
Regardless of whether patients stopped treatment, Eli Lilly’s drug reduced an average of 29.3 AHI events per hour at 52 weeks. In comparison, the placebo group experienced an average of 5.5 fewer events per hour.
Zepbound reduced overall AHI by nearly 59%, compared with a reduction of more than 2% for placebo, including data for patients who discontinued treatment.
In both studies, Zepbound helped patients lose about 20% of their body weight. But Eli Lilly noted that men are known to lose less weight than women with treatments like Zepbound.
Eli Lilly’s Zepbound works by mimicking two naturally occurring gut hormones called GLP-1 and GIP. GLP helps reduce food intake and appetite. GIP also suppresses appetite and may also improve the way the body breaks down sugar and fat.
It is worth noting that Eli Lilly’s main competitor Novo Nordisk There have been no studies on their own effects of weight loss and diabetes medications on people with sleep apnea.
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