FDA Approves Tirzepatide as First Treatment for Obstructive Sleep Apnea and Obesity

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Key Takeaways

Tirzepatide is the first FDA-approved treatment for moderate-to-severe OSA and obesity, used with diet and exercise.
The SURMOUNT-OSA trial showed tirzepatide significantly reduced breathing disruptions and promoted weight loss.
Tirzepatide is a dual-activating GIP and GLP-1 agonist, addressing underlying causes of obesity.
Safety profile of tirzepatide was consistent with previous trials, with mild to moderate gastrointestinal events.

Adults with obstructive sleep apnea who receivied tirzepatide achieved an average of up to 20% weight loss and experienced at least 25 fewer breathing interruptions for each hour slept.

Julie Flygare, JD

(Credit: Project Sleep)

This content originally appeared on our sister site, HCPLive.

According a recent announcement, the FDA has approved tirzepatide (Zepbound; Eli Lilly and Company) as the first and only prescription treatment for adults with moderate-to-severe obstructive sleep apnea (OSA) and obesity, to be used in combination with a reduced-calorie diet and increased physical activity.¹

In November 2023, the FDA initially approved tirzepatide for the treatment of adults with obesity or overweight who also experience weight-related medical problems based on positive findings from the SURMOUNT-1 (NCT04184622) and SURMOUNT-2 (NCT04657003) trials.^2,3 It became the first and only dual-activating glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) agonist for obesity, tackling an underlying cause of excess weight. Now, the agency has approved the treatment for moderate-to-severe OSA and obesity based on positive data from the phase 3 SURMOUNT-OSA trial (NCT05412004).¹

“Too often, OSA is brushed off as ‘just snoring’ – but it’s far more than that. It is important to understand OSA symptoms and know that treatments are available, including new options like [tirzepatide],” Julie Flygare, JD, president and chief executive officer at Project Sleep, said in a statement.¹ “We hope this will spark more meaningful conversations between patients and health care providers and ultimately lead to better health outcomes.”

The SURMOUNT-OSA trial assessed tirzepatide 10 mg or 15 mg in 469 adults with OSA and obesity irrespective of positive airway pressure (PAP) therapy over 52 weeks.⁴Among patients not on PAP therapy, tirzepatide was approximately 5 times more effective than placebo in reducing breathing disruptions, achieving 25 fewer hourly breathing disruptions compared with 5 for the placebo cohort. For those on PAP therapy, tirzepatide demonstrated 29 fewer hourly breathing disruptions compared with 6 for placebo.

At the 1-year mark, approximately 42% of adults treated with tirzepatide and 50% of those on tirzepatide plus PAP therapy experienced remission or mild, non-symptomatic OSA. The respective percentages for the placebo-treated cohorts were 16% and 14%, respectively. Adults treated with tirzepatide also saw an average reduction of 18% body weight (~45 lbs), while those on tirzepatide plus PAP therapy lost an average of 20% body weight (~50 lbs), compared with 2% (~4 lbs) and 2% (~6 lbs) on placebo, respectively.

Safety data reported in SURMOUNT-OSA suggested the observed safety profile was similar to the profile reported in the SURMOUNT and SURPASS trials. The most common events related to tirzepatide were gastrointestinal-related and were considered mild to moderate in severity.

OSA is a breathing disorder during sleep, marked by the partial or complete collapse of the upper airway.⁵This collapse can result in apnea, hypopnea, drops in oxygen levels, and/or brief awakenings from sleep. Although snoring is a classic sign of OSA, other prominent symptoms include fatigue, excessive daytime sleepiness, and fragmented sleep, which can make the condition easy to miss.

“[Tirzepatide] is the first medication that significantly improves moderate-to-severe OSA and aids in long-term weight loss in adults with obesity,” Patrik Jonsson, executive vice president and president of Lilly Cardiometabolic Health and Lilly USA, said in a statement.¹ “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.”

REFERENCES
1. FDA Approves First Medication for Obstructive Sleep Apnea. News Release. FDA. Published December 20, 2024. Accessed December 23, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-first-medication-obstructive-sleep-apnea
2. Jastreboff AM, Aronne LJ, Ahmad NN, et al. Tirzepatide Once Weekly for the Treatment of Obesity. N Engl J Med. 2022;387(3):205-216. doi:10.1056/NEJMoa2206038
3. Garvey WT, Frias JP, Jastreboff AM, et al. Tirzepatide once weekly for the treatment of obesity in people with type 2 diabetes (SURMOUNT-2): a double-blind, randomised, multicentre, placebo-controlled, phase 3 trial. Lancet. 2023;402(10402):613-626. doi:10.1016/S0140-6736(23)01200-X
4. Malhotra A, Bednarik J, Chakladar S, et al. Tirzepatide for the treatment of obstructive sleep apnea: Rationale, design, and sample baseline characteristics of the SURMOUNT -OSA phase 3 trial. Contemp Clin Trials. 2024;141:107516. doi:10.1016/j.cct.2024.107516
5. Slowik JM, Sankari A, Collen JF. Obstructive Sleep Apnea. [Updated 2024 Mar 21]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK459252/