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Lilly obesity drug shows benefit in sleep disorder study, pointing to new use

Fresh clinical trial results for Eli Lilly’s drug Zepbound point to a new use for the weight loss medicine in treating a common sleep disorder, adding to evidence the benefits of so-called GLP-1 agonists could extend across a range of conditions.

Zepbound, which is known scientifically as tirzepatide, significantly reduced episodes of obstructive sleep apnea in overweight or obese participants in two late-stage studies run by Lilly. The drug was effective in people who used a breath device that prevents the airway collapse characterizing the disorder, as well as those who didn’t.

Sleep apnea is associated with obesity, and weight loss has previously been shown to help sleep apnea symptoms.

In one Phase 3 trial of people who weren’t using the breathing devices — called continuous positive airway pressure, or CPAP machines — Zepbound reduced the average hourly number of sleep apnea events by 27, or 55%, after one year, compared with a reduction of five for those given a placebo.

In the second Phase 3 study of people on CPAP machines, Zepbound reduced the average number of hourly sleep apnea events by 30, or 63%, compared with an average of six for those who received a placebo.

People treated with Zepbound in the non-CPAP trial lost 18% of their body weight, while those in the CPAP study lost 20%. Participants on placebo in the studies lost 1% or 2% of their body weight, respectively.

Lilly said it plans to submit the data to the Food and Drug Administration, which has granted the drug Fast Track designation in sleep apnea and obesity, as well as to other drug regulators beginning mid-year. Fuller data from the trials will be revealed at the American Diabetes Association annual meeting in June and published in a medical journal.

The study findings come as Lilly and GLP-1 rival Novo Nordisk seek to expand the use of their weight loss drugs into disorders that arise from obesity and metabolic dysfunction.

Novo recently won FDA approval to begin marketing its drug Wegovy for heart protection after results from a large Phase 3 trial showed it could reduce cardiovascular risk in people with obesity or who were overweight and had heart disease. That data led the U.S. government’s Medicare program for the elderly and disabled to begin covering the drug for some enrollees.

Lilly may not have similar data until 2025.

Wegovy has also show it can ease symptoms of heart failure in people with obesity. Both Novo and Lilly have tested their drugs in the obesity-related fatty liver inflammation disorder known as MASH, with positive mid-stage data reported so far from both.

Zepbound is sold under the brand name Mounjaro for use in treating diabetes.