Mounjaro, Obesity Treatment, Also Approved for Obstructive Sleep Apnea Therapy

Eli Lilly's obesity treatment Mounjaro (active ingredient: Tirzepatide), which was recently launched in Korea, has also been approved as a therapy for obstructive sleep apnea (OSA).

Eli Lilly's diabetes treatment 'Mounjaro (active ingredient Tirzepatide)'. Eli Lilly

On August 21, Eli Lilly Korea announced that on the 19th, Mounjaro received approval from the Ministry of Food and Drug Safety as an adjunct to a low-calorie diet and exercise for the treatment of moderate to severe OSA in adult obese patients with an initial body mass index (BMI) of 30 kg/m² or higher.

Eli Lilly Korea stated that Mounjaro is the first and, so far, the only therapy approved for the treatment of moderate to severe OSA.

Obesity is a condition that directly affects the pathophysiology of OSA, which is the most common type of sleep apnea. The global increase in OSA prevalence is known to be associated with the rising prevalence of obesity. The main symptoms caused by OSA include fatigue, insomnia, sleep disturbances due to breathing difficulties, habitual snoring, and episodes of breathing cessation during sleep. In Korea, the number of sleep apnea patients increased from about 90,000 in 2020 to about 180,000 in 2024, doubling over the past five years.

This expanded approval is based on two phase 3 clinical trials. The SURMOUNT-OSA study was a 52-week, randomized, double-blind, placebo-controlled trial conducted on 469 adults with obesity (BMI 30 kg/m² or higher) and moderate to severe OSA, evaluating the clinical efficacy and safety of Mounjaro at the maximum tolerated dose (10 mg or 15 mg) compared to placebo. The primary endpoint was the change from baseline in the apnea-hypopnea index (AHI) at 52 weeks.

According to the study results, Mounjaro reduced AHI by up to 58.7% from baseline, showing a significant improvement compared to placebo (maximum -2.5%). The Mounjaro group reduced the average number of AHI events per hour by 25.3 to 29.3, while the placebo group only achieved a reduction of 5.3 to 5.5 events per hour.

Notably, in terms of achieving a 50% or greater reduction in AHI-a criterion for determining the success of OSA surgery-the placebo group reached only 23.3% even with positive airway pressure (PAP) therapy, whereas up to 72.4% of patients in the Mounjaro group achieved a reduction of 50% or more in AHI.

Additionally, about half of the patients treated with Mounjaro (Study 1: 42.2%, Study 2: 50.2%) achieved remission of OSA or mild asymptomatic OSA, showing significant improvement compared to placebo (Study 1: 15.9%, Study 2: 14.3%). The percentage reduction in body weight from baseline in the Mounjaro group was 17.7% in Study 1 and 19.6% in Study 2.

The most commonly reported adverse reactions to Mounjaro were gastrointestinal, mostly mild or moderate in severity. The most frequently reported adverse reactions compared to placebo were diarrhea, nausea, constipation, and vomiting.

Ryu Sagi, Executive Director of Cardiometabolic Health at Eli Lilly Korea, said, "As the first therapy to demonstrate meaningful improvement in moderate to severe obstructive sleep apnea, we will do our utmost to ensure that Mounjaro makes a significant contribution to addressing the complex health issues faced by patients in Korea."

This content was produced with the assistance of AI translation services.