Eli Lilly said on Monday that its oral obesity drug Foundayo significantly reduced the severity of obstructive sleep apnea, the most common sleep-related breathing disorder, in obese patients during a late-stage clinical trial.
The drugmaker plans to seek U.S. approval for the once-daily pill before the end of this year for treating moderate-to-severe obstructive sleep apnea (OSA) in adults who are obese or overweight.
These results position the drug — already launched in the U.S. in April — among several GLP-1 therapies showing promise for treating the condition.
OSA refers to breathing that stops during sleep due to a narrowed or blocked airway, which can lead to drops in blood oxygen and rises in blood pressure, and is linked to serious complications such as hypertension, heart failure and stroke.
According to the National Council on Aging, the condition affects nearly 1 billion adults worldwide, including 80 million people aged 20 and older in the U.S. Eli Lilly said in a press release that most people are never diagnosed.
Eli Lilly's blockbuster weight-loss injection Zepbound became the first drug approved in the U.S. for OSA in December 2024.
Beyond that drug, patients have limited treatment options, with many relying on bulky machines that provide positive airway pressure (PAP) to maintain normal breathing.
Dr. Thomas Seck, senior vice president of product development for cardiovascular and metabolic health at Eli Lilly, said in the press release: "Foundayo is already improving the lives of people with obesity, and with plans to submit these results to the FDA before the end of the year, we may have an opportunity to help patients with OSA."
Eli Lilly Sleep Apnea Trial Results
The trial tested Foundayo in two separate studies. The first study enrolled 363 patients who were unable or unwilling to use PAP therapy. The second study enrolled 349 people who had already been on PAP therapy for at least three months at screening and continued that therapy during the trial.
In both studies, patients taking Foundayo started at a low dose and were gradually increased at four-week intervals to different maximum doses.
Researchers specifically examined how much the drug reduced the so-called apnea-hypopnea index (AHI). AHI records the number of times per hour a person experiences restricted or completely blocked airflow during breathing.
The index is used to assess the severity of obstructive sleep apnea and the effectiveness of treatments for the condition.
Results showed that patients taking Foundayo without PAP therapy had an average reduction of 21.1 AHI events per hour at 52 weeks, compared with an average reduction of 4.8 per hour in the placebo group.
Foundayo also met the trial's secondary goal in that group, reducing overall AHI by 43.8%, compared with a 6.3% reduction in the placebo group.
Eli Lilly said 31.5% of participants in the Foundayo group met the criteria for remission or improvement to mild OSA.
Meanwhile, patients receiving both Foundayo and PAP therapy had an average reduction of 18.3 AHI events per hour at 52 weeks, compared with an average reduction of 5.5 per hour in the placebo group.
Foundayo reduced overall AHI by about 27.5% in that group, compared with a 3% reduction in the placebo group.
The company said 19.6% of participants receiving Foundayo and PAP therapy also met the criteria for remission or mild OSA.
Foundayo also reduced the so-called sleep apnea-specific hypoxic burden — a measure of the depth and duration of blood oxygen drops during sleep. That measure fell 55.9% in those not using PAP therapy and 45.8% in those using PAP therapy.
Eli Lilly said the drug also helped patients in each group lose about 11% of their body weight at 52 weeks and helped lower an inflammation marker.
The company said the safety and tolerability of Foundayo were generally consistent with earlier trials of the drug.
Among people taking Foundayo without PAP therapy, about 12% discontinued due to side effects, compared with 3.8% in the placebo group.
Meanwhile, among those receiving Eli Lilly's drug along with PAP therapy, 6.8% discontinued due to side effects, compared with 0.6% in the placebo group.
The most common side effects were gastrointestinal, including nausea, diarrhea, constipation and vomiting, and were generally mild to moderate in severity. This is consistent with other GLP-1 drugs.
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