Lilly weight-loss drug shows promise as a sleep apnea treatment in late-stage trials

Indianapolis-based Eli Lilly and Co. on Wednesday said its popular weight-loss treatment Zepbound showed potential to treat patients with obstructive sleep apnea in two late-stage clinical trials.

Lilly shares rose 0.5%, to close at $750.77 each, after the announcement.

The trials examined tirzepatide, which is sold as Zepbound for obesity and Mounjaro for type 2 diabetes, in patients with obstructive sleep apnea, or OSA, and obesity. OSA is a sleep-related breathing disorder involving complete or partial collapses of the upper airway during sleep, which can lead to apnea or hypopnea and a potential decrease in oxygen saturation and/or waking from sleep. OSA can have serious cardiometabolic complications, contributing to hypertension, coronary heart disease, stroke, heart failure, atrial fibrillation and type 2 diabetes.

The studies looked at adults with moderate-to-severe OSA and obesity for 52 weeks. One study evaluated patients using positive airway pressure, PAP, therapy while the other evaluated those who did not. About 70% of participants across the studies were men, Lilly said.

Researchers examined how much weekly injections of tirzepatide reduced the apnea-hypopnea index, or AHI, which records the number of times per hour a person’s breathing shows a restricted or completely blocked airway.

Lilly said participants in both studies experienced an overall AHI reduction of nearly 63%, compared with a decrease of more than 6% for a placebo. The weight loss observed at 52 weeks with tirzepatide across the two studies was nearly 20%.

“OSA impacts 80 million adults in the U.S., with more than 20 million living with moderate-to-severe OSA. However, 85% of OSA cases go undiagnosed and therefore untreated,” said Dr. Jeff Emmick, senior vice president of product development at Lilly. “Addressing this unmet need head-on is critical, and while there are pharmaceutical treatments for the excessive sleepiness associated with OSA, tirzepatide has the potential to be the first pharmaceutical treatment for the underlying disease.”

Approval of Zephound for sleep apnea could help Lilly get Medicare coverage for the drug because of the added health benefit, analysts said.

Lilly plans to submit results of the trials to the Food and Drug Administration and other regulatory agencies in mid-2024.

Meanwhile, demand for both Zephound and Mounjaro is leading to a shortage of the drugs that is expected to last until at least mid-year. An update of the FDA’s drug shortage database on Wednesday said all all doses of Zepbound and Mounjaro except for the 2.5-milligram versions of both treatments are in a short supply.

Lilly issued the following statement:

“We recognize this situation may cause a disruption in peoples’ treatment regimens and are working with purpose and urgency to address it. As a medicine company, we know that people rely on us to help reach and maintain their health goals, and we take our responsibility very seriously.

“While we anticipate intermittent availability in the near term due to unprecedented demand, we expect our investments in manufacturing and supply capacity to progressively increase production of Mounjaro and Zepbound throughout the second half of 2024. You can find updates on the supply status of these medicines on the FDA Drug Shortages Database.

“Given local and regional supply chain dynamics, patients having trouble obtaining their medicine at one pharmacy may try revisiting their pharmacy at a later time or exploring other pharmacies in their area. Alternatively, if someone continues to experience difficulty obtaining their medicine, they can contact their healthcare provider who can assist with their treatment plan.”

Lilly’s shares have risen 26% since January.