Patrick Wingrove
(Reuters) – Eli Lilly (NYSE:) on Friday said its popular weight loss drug Zepbound helped eliminate moderate to severe obstructive sleep apnea in 52% of patients in two late-stage studies.
US company Lilly and its Danish rival Novo Nordisk (NYSE:) are fighting to get their anti-obesity drugs approved for other diseases. Novo approved Wegovy for cardiovascular disease in March, and Lilly Zepbound’s own cardiovascular disease trial is expected to be completed this year.
In April, Lilly reported that Zepbound, known chemically as tirzepatide, helped reduce episodes of irregular breathing in patients with obstructive sleep apnea by 55% in the first study and by 62.8% in the second.
Patients in the first study received tirzepatide, while patients in the second tested the drug in combination with continuous positive airway pressure (PAP) therapy, which pumps air into the lungs to keep the airways open during sleep.
Full trial results presented Friday at the American Diabetes Association’s scientific conference in Orlando, Florida, showed that Zepbound helped eliminate sleep apnea in 43% of patients taking the drug alone and in 51.5% of those also using PAP.
The criteria for disease resolution was that patients had fewer than five episodes of shallow or no breathing per hour during sleep, or five to 14 episodes and no excessive sleepiness during the day, Lilly said.
Lilly reported that in the first study, 14.9% of patients taking placebo also achieved disease resolution, and in the second study, 13.6% did.
Friday’s data showed that Zepbound helped reduce biomarkers associated with sleep apnea, including oxygen desaturation, blood pressure and C-reactive proteins – signs of inflammation that can indicate heart disease, Lilly said.
The drugmaker said it has submitted an application to the U.S. Food and Drug Administration for approval of Zepbound as a treatment for obstructive sleep apnea and will submit applications to other regulatory agencies around the world in the coming weeks.
Lilly said the overall safety of tirzepatide in these studies was similar to previous studies, with the most common side effects being diarrhea, nausea, vomiting and constipation.
Earlier this month, the Indianapolis-based drugmaker presented data showing Zepbound helps treat liver scarring in patients with a hard-to-treat fatty liver disease called metabolic dysfunction-associated steatohepatitis, or MASH.
(This story has been corrected to change the percentage of placebo patients who achieved disease resolution in the second study from 6.4% to 13.6% in paragraph 7.)