Evidence map›Paper›PMID 38547961›Full record

ArticleContemporary clinical trials2024

Tirzepatide for the treatment of obstructive sleep apnea: Rationale, design, and sample baseline characteristics of the SURMOUNT -OSA phase 3 trial.

Atul Malhotra, Josef Bednarik, Sujatro Chakladar, Julia P Dunn, Terri Weaver, Ron Grunstein, Ingo Fietze, Susan Redline, Ali Azarbarzin, Scott A Sands and 2 more

Registry-linked trialOpen access · greenAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Contemporary clinical trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT05412004. Cited by 55 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
55citing papers in PubMed, 2 pooled it
21.6field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05412004 phase3completed

A Master Protocol to Investigate the Efficacy and Safety of Tirzepatide Once Weekly in Participants Who Have Obstructive Sleep Apnea and Obesity: A Randomized, Double-Blind, Placebo-Controlled Trial

Ran2022Enrolled469Registered outcomes9Posted comparisons20ConditionsObesity, Obstructive Sleep ApneaArmsPlacebo, Tirzepatide
Open the trial in the graph
3 · Its place in the literature

Who cites it

55 citing papers in PubMed, 2 syntheses or guidelines pooled it, 66 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Association of tirzepatide with changes in OSA-related measures based on baseline characteristics - post hoc analyses of SURMOUNT-OSA.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2026
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  11. Review
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  13. Pharmacotherapy in obstructive sleep apnoea: a clinical guide.Sleep & breathing = Schlaf & Atmung · 2026
    Review
  14. Article
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  16. The evolving landscape of obesity pharmacotherapy.Nature reviews. Drug discovery · 2026
    Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 6 institutions in 3 countries.

Atul MalhotraUniversity of California San Diego, La Jolla, CA, USA. Electronic address: amalhotra@health.ucsd.edu.
Josef BednarikEli Lilly and Company, Indianapolis, IN, USA.
Sujatro ChakladarEli Lilly and Company, Indianapolis, IN, USA.
Julia P DunnEli Lilly and Company, Indianapolis, IN, USA.
Terri WeaverCollege of Nursing, University of Illinois Chicago, Chicago, IL, USA; University of Pennsylvania School of Nursing, Philadelphia, PA, USA.
Ron GrunsteinWoolcock Institute of Medical Research and Royal Prince Alfred Hospital, Sydney, Australia.
Ingo FietzeCentre of Sleep Medicine, Charité University Hospital Berlin, Berlin, Germany.
Susan RedlineHarvard Medical School, Boston, MA, USA.
Ali AzarbarzinHarvard Medical School, Boston, MA, USA.
Scott A SandsHarvard Medical School, Boston, MA, USA.
Richard J SchwabDivision of Sleep Medicine, Department of Medicine, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.
Mathijs C BunckEli Lilly and Company, Indianapolis, IN, USA.
Eli Lilly (United States) · USHarvard University · USUniversity of Pennsylvania · USCharité - Universitätsmedizin Berlin · DEUniversity of California, San Diego · USWoolcock Institute of Medical Research · AU

Funding

Is Obstructive Sleep Apnea Important in the Development of Alzheimer's DiseaseR01AG063925 · NIA · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI MALHOTRA, ATUL · 2020 to 2024
$3.7M
Underlying mechanisms of obesity-induced obstructive sleep apneaR01HL148436 · NHLBI · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI Atul Malhotra · 2020 to 2026
$3.4M
Sleep Apnea Endophenotypes: One Size Does Not Fit AllR01HL154926 · NHLBI · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI MALHOTRA, ATUL · 2021 to 2025
$3.3M
The cardiovascular consequences of sleep apnea plus COPD (Overlap syndrome)R01HL166485 · NHLBI · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI Atul Malhotra · 2023 to 2026
$3.1M
VentNet: A Real-Time Multimodal Data Integration Model for Prediction of Respiratory Failure in Patients with COVID-19R01HL157985 · NHLBI · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI MALHOTRA, ATUL, NEMATI, SHAMIM · 2022 to 2025
$2.9M
Developing a Diverse Next Generation of Leaders in Respiratory ScienceT32HL166127 · NHLBI · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI Laura Elise Crotty Alexander, Atul Malhotra · 2023 to 2026
$1.6M
NHLBI NIH HHS R01 HL148436NHLBI NIH HHS R01 HL154926NHLBI NIH HHS R01 HL157985NHLBI NIH HHS R01 HL166485NHLBI NIH HHS T32 HL166127NIA NIH HHS R01 AG063925
6 · The paper itself

Abstract

backgroundWeight 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.

methodsSURMOUNT-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

resultsThe 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.

conclusionSURMOUNT-OSA brings a novel design to investigate if tirzepatide provides clinically meaningful improvement in obesity-related OSA by targeting the underlying etiology.

trial registrationClinicalTrials.gov, NCT05412004.

Indexed as

ObesitySleep Apnea, ObstructiveAdultBody Mass IndexClinical Trials, Phase III as TopicContinuous Positive Airway PressureDouble-Blind MethodFemaleHumansMaleMiddle AgedPolysomnographyRandomized Controlled Trials as TopicResearch DesignSeverity of Illness IndexWeight LossApneaDaily functioningLungObesitySleepWeight loss

Identifiers

PMID38547961
PMCPMC11168245
OpenAlexW4393187269

What OpenQuestion holds

Textmetadata
LicenceTDM
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.