An injectable pen of Zepbound, Eli Lilly's weight loss drug, is displayed in New York City, U.S., on December 11, 2023.
Brendan McDermid | Reuters
Eli Lilly on Wednesday said its 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 initial results add to the long list of potential health benefits of weight loss and diabetes treatments, demand for which has skyrocketed over the past year despite their high prices and spotty insurance coverage.
Zepbound was more effective than a placebo in reducing the severity of obstructive sleep apnea (OSA) in patients with obesity after one year, according to preliminary data from both trials. OSA refers to interrupted breathing during sleep due to narrowed or blocked airways. The pharmaceutical giant said it plans to present the results at an upcoming medical conference and submit them to the Food and Drug Administration and regulators in other countries by mid-2024.
Eli Lilly previously announced that the FDA granted Zepbound “fast track designation” for patients with OSA and moderate to severe obesity. That designation ensures that drugs intended to treat a serious or life-threatening condition and meet an unmet medical need are reviewed more quickly.
The results are an early sign of hope for the approximately 80 million patients in the U.S. who experience OSA, Eli Lilly said in a news release. About 20 million of those people suffer from moderate to severe forms of the disease, but 85% of OSA cases go undiagnosed, according to Eli Lilly.
OSA can cause excessive daytime sleepiness and loud snoring, and contribute to serious complications such as hypertension, stroke, and heart failure. Patients with this condition have limited treatment options other than cumbersome 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 excessive sleepiness associated with OSA, [Zepbound] has the potential to be the first pharmaceutical treatment for the underlying disease,” Dr. Jeff Emmick, senior vice president of product development at Eli Lilly, said in Wednesday's release.
Zepbound has suffered from shortages since receiving approval in the U.S. for weight management in November. The active ingredient in Zepbound, known as tirzepatide, is also approved under the brand name Mounjaro for diabetes.
Mounjaro and other diabetes medications are typically covered by insurance, while Zepbound and other weight loss medications are not. But the new data on sleep apnea patients gives Eli Lilly a “path to obtain Medicare Part D coverage for Zepbound,” even before any changes to coverage under the federal obesity treatment program, the study wrote. JPMorgan Chase analyst Chris Schott said in a note Wednesday.
According to new guidance released in late March, Medicare can cover certain weight-loss medications as long as they receive FDA approval for an additional health benefit. Medicare prescription drug plans run by private insurers, known as Part D, currently cannot cover those drugs alone for weight loss.
Schott added that the new data gives Eli Lilly a path to increase Zepbound use among men. He said the company has suggested that men may be more likely to use a drug called GLP-1, such as Zepbound, for sleep apnea compared with obesity.
Eli Lilly's Zepbound works by mimicking two naturally produced gut hormones called GLP-1 and GIP. LPG helps reduce food intake and appetite. GIP, which also suppresses appetite, may also improve the way the body breaks down sugar and fat.
Initial test results
The two phase three trials, both called SURMOUNT-OSA, tested Zepbound in two groups of patients. Notably, 70% of study participants were men, Eli Lilly said in his statement.
The researchers specifically examined how much the weekly injection reduced the so-called apnea-hypopnea index, or AHI, which tracks the number of times per hour that a person's breathing shows a restricted or completely blocked airway. The index is used to evaluate 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, which was the primary objective of the trials.
Cherries | Stock | fake images
The first study evaluated the drug in adults with obstructive sleep apnea and moderate to severe obesity who were not on PAP therapy.
According to the results, people taking Zepbound had an average of 27.4 fewer AHI events per hour at 52 weeks, compared to an average reduction of 4.8 events per hour for the placebo.
Zepbound also met the trial's second objective, leading to an overall AHI reduction of 55% compared to a 5% decrease for placebo, according to the results.
The second study tested Zepbound in adults with the same conditions, but those patients were receiving and planned to continue PAP therapy.
People taking Zepbound had an average of 30.4 fewer AHI events per hour at 52 weeks, compared to an average reduction of 6 events per hour for placebo.
Zepbound produced an overall AHI reduction of nearly 63%, compared to a decrease of more than 6% for placebo.
The results exceeded Wall Street's expectations. Investors largely considered a 50% reduction as the threshold for considering Eli Lilly's trials a success. The roughly 60% improvement shows “outsized benefits,” Deutsche Bank analyst James Shin wrote in a note Wednesday.
In the two studies, Zepbound helped patients lose about 20% of their weight. But Eli Lilly noted that men are known to lose less weight than women with therapies like Zepbound.
In a note on Wednesday, Morgan Stanley analyst Terence Flynn called the weight reduction encouraging and said the company expected a 15% to 18% weight loss in the test. Morgan Stanley views “this as another positive piece of data supporting the efficacy profile of tirzepatide,” Flynn said.
