Foundayo Meets Primary Goal in Sleep Apnea Study

Eli Lilly reported positive results from a late-stage clinical trial evaluating its oral weight-loss drug Foundayo in adults with obesity and moderate-to-severe obstructive sleep apnea.

The 712-patient study found that treatment significantly reduced breathing interruptions during sleep, meeting its primary objective after 52 weeks. The results could strengthen Lilly’s position in the sleep apnea treatment market by providing a potential oral alternative to existing therapies.

Foundayo users lost approximately 28 pounds on average during the study, regardless of whether they were receiving positive airway pressure therapy.

The results build on Lilly’s existing position in the field. Its injectable obesity medicine Zepbound became the first approved drug for obstructive sleep apnea, while Foundayo could offer patients a more convenient treatment option if it receives an expanded regulatory approval.

Breathing Interruptions Decline Across Both Patient Groups

The trial included two independent studies involving different patient populations. One included 363 participants who were unable or unwilling to use positive airway pressure therapy, while the second involved 349 participants who were using PAP therapy before and during the study.

Among participants not using PAP therapy, Foundayo reduced breathing interruptions by up to 44% after 52 weeks. For those receiving PAP therapy, the reduction reached 27.5%.

The drug also improved oxygen-related measurements during sleep. Oxygen deprivation associated with sleep apnea declined by 55.9% among participants not using PAP therapy and by 45.8% among those using the treatment.

These findings provide additional evidence of Foundayo’s potential to address multiple measures associated with obstructive sleep apnea.

Oral Treatment Could Expand Lilly’s Market Opportunity

Obstructive sleep apnea affects approximately one billion people worldwide. The condition is commonly treated with PAP therapy, which uses a mask to deliver a continuous flow of air to keep the airway open during sleep.

Foundayo belongs to the GLP-1 class of medications and received US approval for weight loss earlier in 2026. Its potential expansion into sleep apnea treatment could provide Lilly with another commercial opportunity, particularly among patients who prefer oral medication.

Analysts indicated that the positive results were largely expected. An expanded approval could nevertheless create another reimbursement opportunity and support broader adoption of Foundayo.

Lilly’s shares rose more than 3% following the announcement, reflecting the market’s response to the additional clinical data and the drug’s potential applications.

What Investors Should Watch Next

The next major milestone will be Lilly’s planned US regulatory submission for Foundayo’s sleep apnea indication by the end of 2026. The approval process will determine whether the drug can enter another treatment category beyond its existing weight-loss indication.

Investors will also be watching how the oral formulation positions Lilly against established sleep apnea therapies and whether the additional indication supports wider adoption and reimbursement.

The trial results strengthen Foundayo’s clinical profile, but its commercial contribution in sleep apnea will depend on regulatory approval and subsequent market uptake.