Lilly's Mounjaro (Tirzepatide) Receives Third Indication Approval in China for Moderate-to-Severe Obstructive Sleep Apnea in Adults with Obesity, Filling a Critical Treatment Gap
Eli Lilly
Global Pharmaceutical R&D and Production Company
Adult patients treated with tirzepatide experienced an average weight loss of 20% and a reduction of at least 27 episodes of apnea-hypopnea per hour of sleep.
After one year of treatment with tirzepatide, more than half of the patients no longer had OSA-related symptoms.
June 30, 2025, Eli Lilly Mu Fengda®(Tirzepatide Injection) has been approved by the National Medical Products Administration (NMPA) of China, becoming the first and currently only prescription medication for treating moderate to severe obstructive sleep apnea (OSA) in adult patients with obesity.1Tirzepatide can improve sleep disorders in obese adult patients with moderate to severe obstructive sleep apnea. The use of this indication should be based on dietary control and increased exercise.
Vice President of Eli Lilly and CompanyGeneral Manager of China
Dehlan
Healthy sleep is an important factor in improving quality of life and preventing chronic diseases, and it is also one of the key goals of the 'Healthy China 2030' strategy. Tirzepatide is the first and currently the only drug that can significantly improve moderate to severe OSA in adult patients with obesity while achieving long-term weight loss. In the past year, the NMPA has approved tirzepatide for two indications: the treatment of type 2 diabetes and long-term weight management. Today, this innovative drug has received approval for its third indication in China, not only once again demonstrating Eli Lilly's outstanding progress in the field of endocrine and metabolism but also marking a new milestone in expanding into the sleep apnea field. This approval not only injects new momentum into Eli Lilly’s development in China but also brings hope to many Chinese patients for improving their quality of life.。
NorthChief Physician of the Department of Respiratory and Critical Care Medicine, Peking Union Medical College Hospital
Chairman of the Sleep-Disordered Breathing Group, Respiratory Disease Branch, Chinese Medical Association
Professor Xiao Yi
Obstructive sleep apnea is a common type of sleep-related breathing disorder, characterized by complete or partial collapse of the upper airway during sleep, leading to apnea or hypopnea, accompanied by decreased blood oxygen saturation and/or micro-arousals. Patients mainly present with clinical symptoms such as snoring during sleep accompanied by apnea, daytime sleepiness, non-restorative sleep, fatigue, and insomnia. Moreover, it is associated with an increased risk of traffic and occupational accidents, cardiovascular diseases, neurological disorders, metabolic conditions, cancer, immune system diseases, and all-cause mortality.
It is estimated that the prevalence of OSA in China is 23.6%, and the prevalence of moderate to severe OSA is 8.8%.2, 41% of patients with moderate to severe OSA are obese3However, due to insufficient awareness of the severity of the disease, the current patient visit rate is low, posing serious health risks.Professor Xiao Yi"Understanding OSA symptoms, emphasizing OSA screening, and recognizing drugs represented by tirzepatide as a new treatment option for patients with moderate to severe OSA combined with obesity."
Senior Vice President of Eli Lilly and Company
Head of Lilly China Drug Development and Medical Affairs Center
Dr. Wang Li
OSA is a highly prevalent disease, and its treatment mainly focuses on lifestyle interventions and device therapy. However, these methods may not address certain risk factors associated with OSA, such as obesity. Tirzepatide is the first and currently the only prescription medication for treating moderate to severe OSA in adult patients with obesity. After treatment, half of the patients no longer experience OSA-related symptoms, providing a breakthrough treatment option for clinicians and patients and filling the gap in pharmacological treatment in this field.
The approval was mainly based on the results of the Phase 3 clinical trial, SURMOUNT-OSA. This one-year trial evaluated the efficacy of tirzepatide (10mg or 15mg) in treating moderate to severe obstructive sleep apnea (OSA) in adult obese patients who were either receiving or unwilling to receive positive airway pressure (PAP) therapy. In adult patients not using PAP therapy, tirzepatide reduced apnea-hypopnea events five times more effectively than placebo—tirzepatide decreased the number of apnea-hypopnea events per hour by 27, compared to only 5 with placebo. In adults using PAP therapy, tirzepatide reduced the number of apnea-hypopnea events per hour by 30, compared to only 6 with placebo. After one year of treatment, 43% of adult patients using tirzepatide alone achieved complete remission of OSA symptoms or a mild OSA status without symptoms, while this proportion was 52% for patients receiving both tirzepatide and PAP therapy; in the placebo group, these figures were 15% and 14%, respectively.
Lead Investigator of SURMOUNT-OSA Study in China
Chief Expert of the Endocrinology Department, National Geriatrics Center, Beijing Hospital
Professor Guo Lixin
Clinically, we have already seen that tirzepatide helps patients achieve safe and effective weight management. The SURMOUNT-OSA study further demonstrates its efficacy in improving moderate to severe OSA in obese patients. In the SURMOUNT-OSA trial, patients treated with tirzepatide experienced at least 27 fewer breathing interruptions per hour during sleep. Notably, nearly half of the participants showed significant improvement, with OSA-related symptoms disappearing. This not only represents an important scientific breakthrough in reducing the disease burden of OSA and improving related health issues but also gives us hope that many patients in China will benefit from this innovative therapy in the future.
In addition to improving OSA symptoms, adult patients receiving tirzepatide treatment experienced an average weight loss of 18.1%, while those receiving both tirzepatide and PAP treatment had an average weight reduction of 20.1%; in contrast, the placebo group showed an average weight loss of 1.3% and 2.3%, respectively.
The safety and tolerability of tirzepatide were consistent with the safety profile of tirzepatide reported in previous trials. The most common adverse events were gastrointestinal adverse events, which were mild to moderate in severity.
About SURMOUNT-OSA
SURMOUNT-OSA (NCT05412004) is a multicenter, randomized, double-blind, parallel, placebo-controlled study designed to compare the efficacy and safety of tirzepatide versus placebo in adult obese patients with moderate to severe obstructive sleep apnea who are unable or unwilling to use positive airway pressure (PAP) therapy (Study 1), as well as in adult obese patients planning to continue using PAP therapy during the trial period (Study 2). According to the master protocol design, 469 subjects from the United States, Australia, Brazil, China, the Czech Republic, Germany, Japan, Mexico, and Taiwan, China were randomly assigned in a 1:1 ratio to receive tirzepatide at the maximum tolerated dose of 10mg or 15mg, or placebo. The primary endpoint of these two studies is to demonstrate the superiority of tirzepatide over placebo in the change from baseline in the apnea-hypopnea index (AHI) at 52 weeks.
In the SURMOUNT-OSA trial, the maximum tolerated dose of tirzepatide administered once weekly was 10 mg or 15 mg. The starting dose of tirzepatide was 2.5 mg, increasing by 2.5 mg every four weeks until the maximum tolerated dose was reached. Subjects who tolerated 15 mg continued to receive 15 mg as the maximum tolerated dose for treatment. Subjects who tolerated 10 mg but not 15 mg continued treatment with 10 mg as the maximum tolerated dose.
About Mufengda (Tirzepatide Injection)
Tirzepatide Injection has been approved by the National Medical Products Administration (NMPA) of China for the treatment of moderate to severe obstructive sleep apnea in adult patients with obesity, in conjunction with dietary control and increased physical activity. Previously, tirzepatide had already been approved by the NMPA for use in:
- Adult patients with type 2 diabetes whose blood glucose remains poorly controlled despite dietary management, exercise, and treatment with metformin and/or sulfonylureas.
- Based on controlling diet and increasing exercise, long-term weight management for adults with an initial Body Mass Index (BMI) meeting the following requirements: ≥28kg/m²2(Obesity), or ≥24kg/m2(Overweight) with at least one weight-related comorbidity (e.g., hypertension, dyslipidemia, hyperglycemia, obstructive sleep apnea, cardiovascular disease, etc.)
Tirzepatide is the first and currently the only approved GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) dual receptor agonist drug. Tirzepatide acts on the root causes of obesity, reducing appetite and food intake.
References
1 Mufengda (Tirzepatide Injection) Instructions
2 Benjafield AV, Ayas NT, Eastwood PR, et al. Estimation of the global prevalence and burden of obstructive sleep apnoea: a literature-based analysis. Lancet Respir Med. 2019;7(8):687-698. doi:10.1016/S2213-2600(19)30198-5
3 .Liu Y, et al. Sleep Breath. 2021 Mar;25(1):189-197
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