Peptide Sciences Tirzepatide Improves Obstructive Sleep Apnea in Obese Patients

According to the results of a trial announced by Eli Lilly on April 17, GLP-1 receptor agonist peptide sciences tirzepatide treatment can improve sleep apnea symptoms in patients with moderate to severe obstructive sleep apnea (OSA) and obesity.

OSA is a sleep-related breathing disorder characterized by complete or partial collapse of the upper airway during sleep, which can lead to apnea or hypopnea and potential decreases in oxygen saturation and or awakening from sleep. OSA can cause serious cardiometabolic complications, leading to hypertension, coronary heart disease, stroke, heart failure, atrial fibrillation and type 2 diabetes.

Peptide sciences tirzepatide is a dual glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 (GLP-1) receptor agonist, first approved in the United States in May 2022 as an adjunct to diet and exercise to reduce hyperglycemia in patients with type 2 diabetes. Soon after, tirzepatide was granted Fast Track designation for chronic weight management in adult patients with obesity or overweight and at least 1 weight-related condition and was approved by the FDA in November 2023.

The double-blind Phase 3 clinical trial (NCT05412004) included 2 groups of patients, those not receiving positive airway pressure therapy (Study 1) and those receiving positive airway pressure therapy (Study 2). Patients included in the trial had to have an apnea-hypopnea index (AHI) of at least 15 events/hour and a body mass index of at least 30kg/m².

Study participants were randomly assigned to receive either 10 mg or 15 mg of tirzepatide (maximum tolerated dose) or placebo once weekly. The primary and secondary endpoints were the same for both studies: change in AHI from baseline to week 52, percentage change in AHI from baseline, and percentage change in weight from baseline to week 52, respectively.

Analysis from SURMOUNT-OSA Study 1 showed that use of peptide sciences tirzepatide was associated with a 27.4 reduction in mean AHI events per hour from initiation to 52 weeks, compared with a 4.8 reduction in mean AHI events per hour with placebo in the efficacy estimate.

Secondary outcome analyses showed that use of tirzepatide was associated with greater reductions in mean AHI (55.0% vs 5.0%) and mean body weight (18.1% vs 1.3%) from initiation to 52 weeks compared with placebo.

Results from SURMOUNT-OSA Study 2 showed that use of tirzepatide was associated with a 30.4 reduction in mean AHI events per hour from initiation to 52 weeks, compared with a 6.0 reduction in mean AHI events per hour with placebo in the efficacy estimate. Secondary outcome analyses showed that the use of peptide sciences tirzepatide significantly reduced mean AHI (62.8% vs 6.4%) and mean body weight (20.3% vs 2.3%) from baseline to 52 weeks compared with placebo treatment.

Safety analyses of the SURMOUNT-OSA study showed that the observed safety profile was similar to that reported in the SURMOUNT and SURPASS trials.

Eli Lilly presented the full data from SURMOUNT-OSA at the 84th Scientific Sessions of the American Diabetes Association on June 21. In addition, Eli Lilly plans to submit the results of SURMOUNT-OSA to the FDA for regulatory review starting in the middle of the year.

"80 million adults in the United States are affected by OSA, of which more than 20 million have moderate to severe OSA. However, 85% of OSA cases are undiagnosed and therefore untreated," said Dr. Jeff Emmick, senior vice president of product development at Eli Lilly. “Addressing this unmet need head-on is critical, and while there are pharmacological treatments for excessive sleepiness associated with OSA, Peptide Sciences’ tirzepatide has the potential to be the first pharmacological treatment for this underlying disorder.”