Zepbound Approved for Obstructive Sleep Apnea in Patients With Obesity

The Food and Drug Administration (FDA) has approved Zepbound^® (tirzepatide) for the treatment of moderate to severe obstructive sleep apnea (OSA) in adults with obesity.

Zepbound is a dual glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist. The approval was based on data from the double-blind, phase 3 SURMOUNT-OSA study (ClinicalTrials.gov Identifier: NCT05412004), which included 2 groups of patients, those who were not on positive airway pressure (PAP) therapy (n=234; Study 5) and those who were (n=235; Study 6). To be included in the trial, patients 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 1:1 to receive Zepbound (10mg or 15mg; maximum tolerated dose) or placebo injected subcutaneously once weekly. The primary endpoint was the change from baseline in AHI at week 52. 

Results showed treatment with Zepbound led to a statistically significant reduction in AHI compared with placebo (Study 5: difference from placebo, -20 [95% CI, -25.8, -14.2]; Study 6: difference from placebo, -23.8 [95% CI, -29.6, -17.9]; P <.001).  Additionally, a greater proportion of patients treated with Zepbound achieved remission or mild nonsymptomatic OSA compared with those who received placebo (Study 5: 42.2% vs 15.9%; Study 6: 50.2% vs 14.3%). Significant reductions in body weight were also observed with Zepbound vs placebo (Study 5: difference from placebo, -16.1% [95% CI, -18, -14.2]; Study 6: difference from placebo, -17.3% [95% CI, -19.3, -15.3]; P <.001).

In both study groups, greater reductions in systolic blood pressure and high-sensitivity C-reactive protein levels were observed with Zepbound compared with placebo. Regarding sleep-related impairment, greater improvement was reported in patients treated with Zepbound vs placebo (assessed by Patient-Reported Outcomes Measurement Information System^® Short Form Sleep-Related Impairment 8a).

The most common adverse events reported with Zepbound were diarrhea, nausea, vomiting, and constipation.

“Zepbound is the first medication that significantly improves moderate to severe OSA and aids in long-term weight loss in adults with obesity,” said Patrik Jonsson, executive vice president, and president of Lilly Cardiometabolic Health and Lilly USA. “Nearly half of clinical trial patients saw such improvements that they no longer had symptoms associated with OSA, marking a critical step forward in reducing the burden of this disease and its interconnected health challenges.”

Zepbound is also indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least 1 weight-related comorbid condition.

This article originally appeared on MPR