Article Synopsis
- The study examines the effectiveness and safety of tirzepatide in treating moderate to severe obstructive sleep apnea (OSA) in individuals with obesity, as traditional weight loss methods can be difficult.
- The SURMOUNT-OSA trial is a randomized and placebo-controlled phase 3 study that includes 469 participants, with some receiving no current OSA treatment and others using positive airway pressure therapy, while all are also undergoing lifestyle interventions for weight reduction.
- The primary outcome measures the difference in apnea hypopnea index after 52 weeks between the tirzepatide and placebo groups, alongside various secondary outcomes related to sleep quality, physical activity, and cardiometabolic health.
Video Abstracts
Category Ranking
98%
Total Visits
921
Avg Visit Duration
2 minutes
Citations
20
Article Abstract
Background: Weight reduction is a standard recommendation for obstructive sleep apnea (OSA) treatment in people with obesity or overweight; however, weight loss can be challenging to achieve and maintain without bariatric surgery. Currently, no approved anti-obesity medication has demonstrated effectiveness in OSA management. This study is evaluating the efficacy and safety of tirzepatide for treatment of moderate to severe OSA in people with obesity.
Methods: SURMOUNT-OSA, a randomized, placebo -controlled, 52-week phase 3 trial, is investigating the efficacy and safety of tirzepatide for treatment of moderate to severe OSA (apnea hypopnea- index ≥15 events/h) in participants with obesity (body mass index ≥30 kg/m) and an established OSA diagnosis. SURMOUNT-OSA is made of 2 intervention-specific appendices (ISAs): ISA-1 includes participants with no current OSA treatment, and ISA-2 includes participants using positive airway pressure therapy. Overall, 469 participants have been randomized 1:1 to receive tirzepatide or placebo across the master protocol (ISA-1, n = 234; ISA-2, n = 235). All participants are also receiving lifestyle intervention for weight reduction.
Results: The primary endpoint for the individual ISAs is the difference in apnea hypopnea- index response, as measured by polysomnography, between tirzepatide and placebo arms at week 52. Secondary endpoints include sleep apnea-specific hypoxic burden, functional outcomes, and cardiometabolic biomarkers. The trial employs digital wearables, including home sleep testing to capture time to improvement and accelerometry for daily physical activity assessment, to evaluate exploratory outcomes.
Conclusion: SURMOUNT-OSA brings a novel design to investigate if tirzepatide provides clinically meaningful improvement in obesity-related OSA by targeting the underlying etiology.
Trial Registration: ClinicalTrials.gov, NCT05412004.
Download full-text PDF |
Source |
|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC11168245 | PMC |
| http://dx.doi.org/10.1016/j.cct.2024.107516 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Obesity treatment as a bridge to solid organ transplantation: A comparison of bariatric surgery to medical therapy.
Obes Pillars
December 2025
University of Oklahoma, School of Community Medicine, USA.
Background: Organ transplant is a rapidly growing area of medicine, with over 42,800 organ transplants occurring in 2022.[1] Obesity complicates the transplant surgery process; historically, the only available treatment for patients with both severe obesity and end-organ damage requiring transplant was bariatric surgery. Glucagon-like peptide-1 (GLP-1) and dual GLP-1/glucose-dependent insulinotropic polypeptide (GIP) agonists (such as semaglutide and tirzepatide, respectively) may offer a non-surgical alternative to weight management prior to transplant surgery.
View Article and Find Full Text PDFTirzepatide for the Maintenance of Body Weight Reduction: Rationale, Design, and Baseline Characteristics of SURMOUNT-MAINTAIN.
Obesity (Silver Spring)
September 2025
Eli Lilly and Company, Indianapolis, Indiana, USA.
Objective: SURMOUNT-MAINTAIN aims to evaluate the efficacy and safety of reducing the tirzepatide dose and/or continuing the maximum tolerated dose (MTD) versus placebo in maintaining body weight (BW) reduction achieved with tirzepatide MTD.
Methods: This Phase 3b, multicenter, randomized, parallel-arm, double-blinded, placebo-controlled, 52-week clinical trial is in progress comparing treatment with once weekly tirzepatide (5 mg and/or MTD of 15 mg or 10 mg) versus placebo in achieving BW reduction maintenance from the initial 60-week open-label weight-loss period on tirzepatide MTD, in adults with obesity (BMI ≥ 30 kg/m or ≥ 27 kg/m with ≥ 1 obesity-related comorbidity, excluding type 2 diabetes). The primary endpoint is percent maintenance of BW reduction achieved during the weight-loss period at Week 112 among those who reached a BW plateau (i.
Obesity as a Chronic Disease: A Narrative Review of Evolving Definitions, Management Strategies, and Cardiometabolic Prioritization.
Adv Ther
September 2025
Jim and Eleanor Randall Department of Surgery, Section of Obesity Medicine, Center for Weight Management and Metabolic Health, Cedars Sinai Medical Center, 8635 W. 3rd Street, West Tower, Suite 795, Los Angeles, CA, 90048, USA.
Obesity is a multifactorial, complex disease that is driven by genetic, biological, environmental, and behavioral factors. In this review, we explain the key contributors to obesity, limitations in current definitions, its relationship with cardiometabolic health, and recent advancements in treatment. Obesity is characterized by the presence of excess and dysfunctional adipose tissue, driven by chronic inflammation and maladaptive energy homeostasis.
View Article and Find Full Text PDFCase Report: Rhabdomyolysis following initiation of tirzepatide.
Front Pharmacol
August 2025
Department of Internal Medicine, University Medicine, Rostock, Germany.
We present the case of a 66-year-old woman who developed weakness, nausea, and vomiting accompanied by markedly elevated creatine kinase levels after first treatment with an increased dose of tirzepatide. Laboratory findings were consistent with rhabdomyolysis and normalized within 4 days following discontinuation of tirzepatide and initiation of supportive intravenous fluid therapy. The temporal relationship strongly suggests tirzepatide as a likely trigger.
View Article and Find Full Text PDFGeneralizability of SURPASS-CVOT to the United States: A Nationally Representative Study.
Prog Cardiovasc Dis
September 2025
Mount Sinai Fuster Heart Hospital, Icahn School of Medicine at Mount Sinai, New York, NY, USA. Electronic address: