LivingGLP1
Study S000156

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

Included trial: extracted dataClinicalTrials.gov recordStudy Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration
NCT05412004
Acronym
SURMOUNT-OSA
Study type
INTERVENTIONAL
Allocation
RANDOMIZED
Phase
PHASE3
Masking
DOUBLE
Status
COMPLETED
Enrollment
469
Start
2022-06-21
Primary completion
2024-03-12
Lead sponsor
Eli Lilly and Company
Conditions
Obstructive Sleep Apnea; Obesity
Interventions
DRUG:Tirzepatide; DRUG:Placebo
Results posted
TRUE
Individual participant data sharing
YES
Secondary identifiers
OTHER:I8F-MC-GPIF; OTHER:I8F-MC-GPI1; OTHER:I8F-MC-GPI2; EUDRACT_NUMBER:2021-004552-41

Registered primary outcomes

  • Change From Baseline in Apnea-Hypopnea Index (AHI) [Baseline, Week 52]

Linked records (15)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.
RecordTitleYearDesignIdentifiersLink basis
R0005976Association of tirzepatide with changes in OSA-related measures based on baseline characteristics - post hoc analyses of SURMOUNT-OSA.
Falcon B, Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine
2026Randomized trialPMID 42675225DOIcites ClinicalTrials.gov:NCT05412004; registry reference DERIVED:42675225
R0013891Changes in patient-reported outcomes and objective assessments based on baseline symptom severity in SURMOUNT-OSA: post-hoc analyses.
Kanu C, Sleep
2026Randomized trialPMID 42412744DOIcites ClinicalTrials.gov:NCT05412004
R0014121Patients' Experiences of Obstructive Sleep Apnea and Tirzepatide Treatment: An Exit Interview Study.
Shinde S, The patient
2026Other trialPMID 41793578DOIcites ClinicalTrials.gov:NCT05412004; registry reference DERIVED:41793578
R0016217Tirzepatide on obstructive sleep apnea-related cardiometabolic risk: secondary outcomes of the SURMOUNT-OSA randomized trial.
Malhotra A, Nature medicine
2026Randomized trialPMID 41540105DOIcites ClinicalTrials.gov:NCT05412004; registry reference DERIVED:41540105
R0011011Tirzepatide for sleep-disordered breathing in SURMOUNT-OSA: Time course and association with body weight.
Malhotra A, Sleep medicine
2025Randomized trialPMID 41135142DOIcites ClinicalTrials.gov:NCT05412004; registry reference DERIVED:41135142
R0016265Effect of tirzepatide treatment on patient-reported outcomes among SURMOUNT-OSA participants with obstructive sleep apnea and obesity.
Kanu C, Sleep medicine
2025Randomized trialPMID 40774158DOIcites ClinicalTrials.gov:NCT05412004; registry reference DERIVED:40774158
R0038263Tirzepatide-related improvement in sleep disordered breathing and hypoxic burden and its association with sleep apnoea cardiometabolic outcomes
Ali Azarbarzin
2025Randomized trialDOIcites ClinicalTrials.gov:NCT05412004
R00409740775 OSA Outcomes in Participants by Baseline BMI Classification from SURMOUNT-OSA Trials: A Post-Hoc Analysis
Ronald R. Grunstein, SLEEP
2025OtherDOIcites ClinicalTrials.gov:NCT05412004
R0045923Tirzepatide Improved Sleep Disordered Breathing in Adults with Obstructive Sleep Apnea with Obesity: Results from SURMOUNT-OSA Trials.
Atul Malhotra, Diabetologie und Stoffwechsel
2025Randomized trialDOIcites ClinicalTrials.gov:NCT05412004
R0047771Measures Related to Obstructive Sleep Apnea After Tirzepatide Treatment by Baseline OSA Severity: Post-hoc Analyses of SURMOUNT-OSA
Birong Liao, American Journal of Respiratory and Critical Care Medicine
2025Other trialDOIcites ClinicalTrials.gov:NCT05412004
R0054900Late Breaking Abstract - Tirzepatide and Nocturnal Hypoxia (T90): SURMOUNT-OSA post hoc analyses
Ingo Fietze
2025OtherDOIcites ClinicalTrials.gov:NCT05412004
R0018977Tirzepatide for the Treatment of Obstructive Sleep Apnea and Obesity.
Malhotra A, The New England journal of medicine
2024Randomized trialPMID 38912654DOIcites ClinicalTrials.gov:NCT05412004; registry reference DERIVED:38912654
R0019492Tirzepatide for the treatment of obstructive sleep apnea: Rationale, design, and sample baseline characteristics of the SURMOUNT -OSA phase 3 trial.
Malhotra A, Contemporary clinical trials
2024ProtocolPMID 38547961DOIcites ClinicalTrials.gov:NCT05412004; registry reference DERIVED:38547961
R0041831O064 Tirzepatide reduced sleep apnea severity in adults with obstructive sleep apnea and obesity: results from the SURMOUNT-OSA trial
Ronald R. Grunstein, SLEEP Advances
2024Randomized trialDOIcites ClinicalTrials.gov:NCT05412004
R0017381The potential impact of GLP-1 agonists on obstructive sleep apnoea.
Hamilton GS, Respirology (Carlton, Vic.)
2023Randomized trialPMID 37419864DOIcites ClinicalTrials.gov:NCT05412004