The diabetes and weight loss drug tirzepatide appears to help people with obesity who also have sleep apnea, according to preliminary findings from drug maker Eli Lilly.
The results, while unpublished, are the latest in a string of hopeful signs for a new generation of drugs developed to treat diabetes.
The drugs, generally called GLP-1s, are the most effective ever at helping people lose weight. In recent months, trials have shown them to be effective against other conditions, particularly heart problems among people with obesity, for which one drug recently received federal approval. The effectiveness may now extend to patients with moderate-to-severe sleep apnea, who often have obesity.
“The data represents a potential huge step forward patients living with moderate-to-severe sleep apnea and obesity who are really looking for additional treatment options,” Dr. Jeff Emmick, Eli Lilly’s senior vice president of product development, told USA TODAY.
He noted that tirzepatide, sold for obesity under the brand name Zepbound, would become the first drug treatment for sleep apnea. “There’s a significant unmet need, and it’s a serious disease.”
Untreated sleep apnea is associated with earlier brain aging and Alzheimer’s, cardiovascular disease, stroke and premature death, Dr. Charles Czeisler, director of Harvard Medical School’s Division of Sleep Medicine, has told USA TODAY.
What is sleep apnea?
Sleep apnea is characterized by disturbed breathing caused by a collapsed upper airway while asleep. It’s strongly associated with obesity, with neck circumference and fat thought to play a role in collapsing airways to reduce or fully block airflow. About 70% of patients with sleep apnea also have obesity, Emmick said.
Nationally, around 39 million U.S. adults have sleep apnea, according to the National Council on Aging. A significant number of people with sleep apnea are also obese. Prior research suggests the number of people with sleep apnea is underreported.
What the new study found
Lilly’s study looked at two international groups of around 230 people each who took the drug in injections of 10 to 15 mg for a year. Most of the participants were male, Emmick said, distinguishing them from volunteers in Lilly’s weight-loss trials, who have been mostly female. The men in both groups lost nearly 20% of their body weight, he said, confirming the weight-loss benefits of the drug for both sexes.
Lilly declined to provide the full study or additional data to USA TODAY.
In the first group, patients took the drug without a positive airway pressure (PAP) machine to pump air into their lungs. Members of this group saw a 55% drop in their apnea-hypopnea index (AHI) scores, which is used to gauge interruptions in sleep. They had 27 fewer AHI events per hour. Any change of 15 points or more is considered “clinically relevant,” that is, likely to offer noticeable health benefits.
The second group used PAP machines while taking the drug. The study found a 63% reduction in their AHI scores, and an AHI drop of 30.4 events each hour in the group, again substantially above the 15-point threshold.
People who received placebos instead of the active drug did not see a clinically meaningful improvement in their apnea scores, the data showed.
“These are very marked reductions,” Dr. Eric Topol, professor and executive vice president of Scripps Research in La Jolla, California, said of the results. “It looks promising. It looks like they nailed it.”
The findings remain unpublished until the summer, when Lilly plans to share results at the American Diabetes Association’s annual conference.
What this new finding means
Emmick said Lilly would ask FDA this summer to approve tirzepatide for use in patients with obesity and sleep apnea.
Such approval would pave the way for the drug to be covered by Medicare and private insurers, many of which won’t cover the drug for obesity alone. Zepbound typically retails for over $1,000 a month without insurance.
(Lilly offers savings programs for Zepbound at www.Zepbound.lilly.com and Mounjaro at Mounjaro.com/savings.)
Topol said he’s concerned with the idea of having people take a “forever drug” to manage their sleep apnea. “Just for the sake of cost, no less durability and other unknown long-term side effects,” he said.
“This story had just gotten so extraordinary about the new drugs but this is the one thing that’s totally unsolved and not really addressed and too many people are just saying … take it for the rest of your life. I think we need to come up with a better solution,” he said.
What is tirzepatide?
Tirzepatide, sold under the brand names Zepbound and Mounjaro, includes a so-called GLP-1 (glucagon-like peptide-1) receptor agonist, which is the same kind of treatment found in semaglutide, the ingredient in both Wegovy and Ozempic, the weight-loss and diabetes drugs sold by Novo Nordisk. In addition, tirzepatide includes a molecule that activates the body’s receptors for GIP (glucose-dependent insulinotropic polypeptide).
The Food and Drug Administration approved Zepbound last November as a weekly injection, in combination with a reduced-calorie diet and increased physical activity for with obesity or overweight with at least one weight-related medical condition. It is the same medication as Mounjaro, approved by the FDA in May 2022 to treat type 2 diabetes.
Some doses of both Mounjaro and Zepbound, along with Lilly’s type 2 diabetes drug Trulicity (dulaglutide) have been in shortage in the United States.
Lilly has a dedicated supply website to keep patients updated on availability of the drugs and suggests people revisit their pharmacy or check neighboring ones at least a week before needing to refill prescriptions. The company has invested in manufacturing and supply capacity to increase production this year and in the future.
