Lilly stated on Monday that its weight-loss pill Foundayo significantly reduced the severity of obstructive sleep apnea in obese patients in a late-stage trial. Obstructive sleep apnea is the most common sleep-related breathing disorder.

This pharmaceutical company plans to submit an application to the United States by the end of this year in order to seek approval for this daily oral medication for the treatment of moderate to severe obstructive sleep apnea in adults who are obese or overweight ( OSA ). This means that this pill, which was launched in the United States in April of this year, has become one of several GLP-1 therapies that have shown promise in treating this disease.

OSA refers to interruptions in breathing during sleep caused by narrowed or blocked airways, which can lead to a decrease in blood oxygen levels and an increase in blood pressure, and are associated with serious complications such as hypertension, heart failure, and stroke. According to data from the National Council on Aging in the United States, nearly 1 billion adults worldwide are affected by this condition, including 80 million people in the U.S. population aged 20 and above. Eli Lilly stated in a statement that most of these individuals have never been diagnosed with it.

Eli Lilly's groundbreaking weight loss injection drug, Zepbound, became the first medication to receive US approval in December 2024 for the treatment of OSA. Apart from this drug, patients have limited treatment options; many rely on bulky positive pressure ventilation devices ( PAP) to maintain normal breathing.

Dr. Thomas Seck, Senior Vice President of Product Development for Eli Lilly's Cardiovascular and Metabolic Health, stated in a declaration: " Foundayo has already made a difference for obese patients, and if we submit these results to FDA by the end of the year as planned, we will have the opportunity to help those suffering from OSA."

Lilly Sleep Apnea Test Results

This trial tested Foundayo through two independent studies. The first study included 363 patients who were unable or unwilling to use PAP for treatment. The second study included 349 patients who had received at least three months of PAP treatment during screening and continued that treatment throughout the trial.

In both studies, patients taking Foundayo started with a low dose and gradually increased it every four weeks to different maximum doses.

Researchers focused on examining the extent to which the drug reduced what is known as the Apnea-Hypopnea Index ( AHI ). AHI records the number of times per hour a person experiences restricted breathing or complete obstruction of the airway. This index is used to assess the severity of obstructive sleep apnea and the effectiveness of related treatments.

The results show that among the population not treated with PAP, patients taking Foundayo experienced an average reduction of 21.1 AHI events per hour at 52 weeks, while the placebo group saw an average reduction of 4.8 events per hour.

Foundayo also achieved the second goal of the trial among this group: the overall reduction was 43.8%, compared to a 6.3% reduction in the placebo group. Eli Lilly stated that 31.5% of the participants in the Foundayo group met the criteria for remission, or improved to a mild OSA.

At the same time, among patients who received treatment with both Foundayo and PAP, there was an average reduction of 18.3 AHI events per hour at 52 weeks, whereas in the placebo group, there was an average reduction of 5.5 events per hour.

In this group, Foundayo caused a overall decrease of about 27.5% in AHI, while the placebo group saw a decrease of 3%. The company stated that among the participants who received treatment with Foundayo and PAP, 19.6% also met the remission criteria or improved to a mild level of OSA.

Foundayo also reduced the so-called specific hypoxic burden of sleep apnea, which is an indicator that measures the depth and duration of oxygen levels dropping during sleep. In the population not treated with PAP, this indicator decreased by 55.9%; in the population treated with PAP, this indicator decreased by 45.8%.

Eli Lilly stated that this pill also helped patients in all groups lose approximately 11% of their weight at 52 weeks, and it contributed to reducing a certain inflammatory marker.

The company stated that the safety data, as well as patients' tolerance to Foundayo, are generally consistent with the results of previous trials of this drug.

Among those who did not use PAP for treatment, approximately 12% of Foundayo users discontinued the medication due to side effects, compared to 3.8% in the placebo group. Meanwhile, in the group that used both Eli Lilly tablets and PAP for treatment, 6.8% of patients stopped taking the medication due to side effects, whereas in the placebo group, this figure was 0.6%.

The most common adverse reactions are gastrointestinal reactions, including nausea, diarrhea, constipation, and vomiting, and the overall severity is mild to moderate. This is consistent with other GLP-1 drugs.