American Diabetes Scientific Sessions, 21 June, 2024 – In a Phase III trial (SURMOUNT-OSA, NCT05412004) of patients with moderate-to-severe sleep apnea and obesity, tirzepatide demonstrated significant improvements in both sleep apnea scores as well as cardiometabolic risk factors including body weight, hsCRP and systolic blood pressure. 

SURMOUNT-OSA investigated tirzepatide’s effects in a two-part, double-blind, randomized trial. Those already using positive airway pressure (PAP) were included in phase 1, while phase 2 focused on patients not receiving PAP. Patients received maximally tolerated dose of tirzepatide (up to 10mg or 15mg) once daily for 52 weeks. The primary endpoint was a change in apnea–hypopnea index (AHI, the number of apneas and hypopneas during an hour of sleep) from baseline. Secondary outcomes included body weight, changes in hypoxic burden, patient-reported sleep impairment and disturbance, high-sensitivity C-reactive protein (hsCRP) concentration and systolic blood pressure.

Improvements in AHI were seen in patients without baseline PAP estimated at −20.0 events per hour (95% CI, −25.8 to −14.2) (P<0.001) or without PAP at baseline −23.8 events per hour (95% CI, −29.6 to −17.9) (P<0.001). Additionally, both groups reported improvements in sleep quality, with reductions in patient-reported sleep impairment and sleep disturbance scores.

The study also showed positive impacts on cardiometabolic risk factors. Participants experienced significant reductions: 17-20% in body weight (p<0.001), 40-50% in hsCRP levels (p<0.01), and a clinically significant reduction in systolic blood pressure of 7.6-9.6 mmHg (p<0.05).

Professor Atul Malhotra, the study's principal investigator, said “The results of the study have demonstrated the ability of tirzepatide to address both obesity and sleep apnea, offering an effective and comprehensive treatment solution,(…) and could revolutionize how we manage these interconnected conditions".

Sources:

Malhotra A. ADA 2024. Tirzepatide for the Treatment of OSA and Obesity [Power Point Presentation].

American Diabetes Association. (2024, June 21). Use of Tirzepatide Shown to Improve Sleep Apnea and Cardiovascular Outcomes [Press release].

Malhotra A, et al. NEJM 2024.Tirzepatide for the Treatment of Obstructive Sleep Apnea and Obesity. DOI: 10.1056/NEJMoa2404881