ORLANDO — Eli Lilly said Zepbound helped at least 43% of patients with obstructive sleep apnea and obesity resolve symptoms of the breathing disorder in late-stage trials.
At the American Diabetes Association scientific sessions on Friday, Lilly spelled out the data from the Phase 3 trials two months after releasing topline results for SURMOUNT-OSA 1 and SURMOUNT-OSA 2.
In SURMOUNT-OSA 1, which included patients who were not using PAP therapy, 43% of participants on the highest dose met the criteria for disease resolution. In SURMOUNT-OSA 2, which included patients who were using PAP therapy, 51.5% reached disease resolution.
“That’s a very encouraging result of the study,” Mathijs Bunck, Lilly’s associate VP of medical development for tirzepatide obesity and NILEX, told Endpoints News. “We’ll do additional analysis to look into that and what it actually means, but it strengthens our confidence that tirzepatide can be a treatment for people with moderate to severe obstructive sleep apnea and obesity together.”
Lilly defined disease resolution as having either fewer than five sleep apnea events per hour on the apnea-hypopnea index (AHI), or between five and 14 AHI events per hour and a score of less than 10 on the Epworth Sleepiness Scale, a questionnaire that assesses feelings of excessive sleepiness during the day. AHI is a metric used to rate the severity of a patient’s sleep apnea by recording how many times a person’s airflow is restricted or blocked over an hour.
Bunck said the company has already filed for a label expansion with the FDA in sleep apnea and plans to submit more applications in the EU and other markets in the coming months. It would be the first drug approved for the breathing disorder, which affects 20 million people worldwide. An estimated 70% of those affected also have obesity.
Both trials met all endpoints. Across both 52-week studies, patients saw a mean reduction of up to 62.8% on the AHI, or around 30 fewer times that a patient’s airflow was restricted or blocked per hour of sleep, compared to placebo.
In SURMOUNT-OSA 1, the GIP/GLP-1 injection led to a mean AHI reduction of 27.4 events per hour from baseline. In the second study, there was a mean AHI reduction of 30.4 events per hour from baseline.
Patients also saw weight loss consistent with previous studies of the drug, which is marketed as Zepbound for obesity and Mounjaro for type 2 diabetes. The weight loss was, on average, 18% in OSA 1 and 20% in OSA 2. The trials also showed improvements in blood pressure and levels of the high-sensitivity C-reactive protein, an inflammation biomarker.
As for why Zepbound has a positive impact on sleep apnea, Bunck said that some breathing disorders are caused by excess fat in the upper airway, which causes an obstruction. Bunck told Endpoints that Lilly looked at the correlation in the trial, but the full dataset hasn’t yet been analyzed.
“It’s also important to look at the disease more holistically,” Bunck said. “Sleep apnea and obesity are so related and they lead to the same outcomes, which is myocardial infarction, stroke, and other cardiovascular disease.”