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Eli Lilly and Company will submit results of the study to support tirzepatide (Zepbound) for treatment of obstructive sleep apnea later this year.
Tirzepatide (Zepbound; Eli Lilly and Company) injections in the 10 mg and 15 mg dosage demonstrated reductions in apnea-hypopnea index (AHI) compared with the placebo for patients with obstructive sleep apnea (OSA), according to positive topline results of the SURMOUNT-OSA phase 3 clinical trials. Tirzepatide is the only approved glucose-dependent insulinotropic poly peptide and glucagon-like peptide-1 treatment for chronic weight management.1
Tirzepatide was first approved to treat adults with type 2 diabetes in May 2022 as Mounjaro,2 and most recently received approval for chronic weight management in adults who have obesity or overweight and at least 1 weight-related condition, such as high blood pressure, type 2 diabetes, or high cholesterol.3
Man sleeping in bed wearing CPAP mask.
Image Credit: sbw19 - stock.adobe.com
"OSA impacts 80 million adults in the [United States], with more than 20 million living with moderate-to-severe OSA. However, 85% of OSA cases go undiagnosed and therefore untreated," Jeff Emmick, MD, PhD, senior vice president of product development at Lilly, said in a press release. "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."1
The SURMOUNT-OSA (NCT05412004) was a multicenter, randomized, double-blind trial that compared the efficacy and safety of tirzepatide with the placebo in adults who have moderate-to-severe OSA and obesity and were unable or unwilling to use positive airway pressure therapy (PAP) and those who were planning on staying on PAP therapy. There were 469 individuals included in the study across the United States, Australia, Brazil, China, Czechia, Germany, Japan, Mexico, and Taiwan.1
The SURMOUNT-OSA Study 1 included adults with moderate-to-severe OSA and obesity who were not on positive airway pressure therapy. At 52 weeks, tirzepatide demonstrated a reduction in mean AHI from baseline of approximately 27.4 events per hour compared to 4.8 events per hour for the placebo. AHI records the number of times the patient’s breathing is restricted or completely blocked per hour and is used to determine effectiveness of treatment and severity of OSA.1
For the key secondary outcome of percentage change in AHI, tirzepatide showed a reduction in mean AHI of 55% from baseline compared to 5% with the placebo. Further, the drug also led to a mean body weight reduction of 18.1% and 1.3%, respectively.1
For SURMOUNT-OSA Study 2, the drug was evaluated in individuals with moderate-to-sever OSA and obesity who were on and planned to continue to use PAP therapy. At 52 weeks, tirzepatide demonstrated a reduction in mean AHI from baseline of 30.4 events per hour compared to 6 events per hour with the placebo. For the key secondary outcome, tirzepatide showed reductions in mean AHI of 62.8%compared to 6.4%, respectively, and a mean body weight reduction of 20.1% and 2.3%, respectively.1
Trial Name: Obstructive Sleep Apnea Master Protocol GPIF: A Study of Tirzepatide (LY3298176) in Participants With Obstructive Sleep Apnea
ClinicalTrial.gov ID: NCT05412004
Sponsor: Eli Lilly and Company
Completion Date (Estimated): March 2024
Investigators reported that the overall safety profile of tirzepatide was similar to those reported in the SURMOUNT and SURPASS trials, with the most commonly reported adverse events (AEs) being gastrointestinal-related and mild to moderate in severity. AEs included diarrhea, nausea, vomiting, and constipation.1
Results from the SURMOUNT-OSA trial will be presented during a symposium at the American Diabetes Association’s 84th Scientific Session on June 21, 2024, according to the press release. Further, the company plans to submit this data to the FDA and other regulatory agencies beginning mid-year.1
According to the National Council on Aging, approximately 39 million adults in the United States have OSA, and when left untreated, can lead to heart, kidney, and metabolic health complications.4
