The makers of the weight loss drug tirzepatide, which is branded commercially as Zepbound, announced Wednesday the results of a Phase 3 study showing that the drug was effective in treating sleep apnea.
Eli Lilly said that 10- and 15-milligram injections of Zepbound "significantly reduced the apnea-hypopnea index" among those who have obesity and moderate-to-severe obstructive sleep apnea.
Among those in one drug study, it led to an average apnea-hypopnea index reduction of 27.4 events per hour compared to a reduction of 4.8 events per hour for those on a placebo. In a second study, Zepbound led to an average apnea-hypopnea index reduction of 30.4 events per hour compared to a reduction of six events per hour for those on a placebo. Both studies followed patients for a year.
Those who have at least 30 apnea-hypopnea index events per hour of sleep are considered to have severe obstructive sleep apnea, while those who have 15-30 events per hour have moderate obstructive sleep apnea.
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Eli Lilly said there was nearly a 20% reduction in weight among those in the trials.
The company said it plans to submit its findings to the Food and Drug Administration and other global regulatory agencies beginning mid-year.
"OSA (obstructive sleep apnea) 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 with Eli 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."
According to the National Council on Aging, obstructive sleep apnea occurs when the upper airway becomes blocked during sleep, interfering with breathing. Older people, men and people who are overweight are more likely to have sleep apnea.
The organization estimates that 33 million Americans use a CPAP machine to treat sleep apnea.
Eli Lilly says that Zepbound uses hormone receptors to help people who are considered obese or overweight lose weight and keep it off.
Eli Lilly said those who took the highest dosage of Zepbound lost an average of 48 pounds after 72 weeks, while those taking the drug's lowest dosage lost an average of 34 pounds. Those given a placebo lost seven pounds after 72 weeks, the company said.
However, these weight loss drugs do have side effects. Eli Lilly noted that Zepbound can be related to numerous adverse gastrointestinal reactions.
Eli Lilly says Zepbound has a list price of $1,059 per monthly dose. The company says those with insurance may be eligible to pay as low as $25 for a one-month or three-month prescription. Those forced to pay out of pocket may be eligible to pay as low as $550 for a one-month prescription.
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