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Study · Randomized controlled trial · 2025

8 results

Effect of tirzepatide treatment on patient-reported outcomes among SURMOUNT-OSA participants with obstructive sleep apnea and obesity.

Kanu C, Shinde S, Chakladar S, Dennehy EB, Weaver TE, Poon JL, Malhotra A

Sleep medicine6 Aug 2025Cited by 17 (Europe PMC)

PMID40774158 (opens in a new tab)PMCIDPMC12720398 (opens in a new tab)DOI10.1016/j.sleep.2025.106719 (opens in a new tab)PepBankPUB-40774158
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Summary

AimIn the phase 3 SURMOUNT-OSA trials, tirzepatide treatment significantly reduced the apnea-hypopnea index (AHI) among people with moderate-to-severe obstructive sleep apnea (OSA) and obesity. We evaluated effects of tirzepatide treatment on sleep disturbance, sleep-related impairment, functioning, health-related quality of life (HRQoL), and OSA symptoms in SURMOUNT-OSA participants.MethodsSURMOUNT-OSA consisted of two randomized, placebo-controlled trials of tirzepatide (10 mg or 15 mg) or placebo for 52 weeks in participants with moderate-to-severe OSA and obesity. For participants using PAP (Study 2), PAP was withdrawn prior to assessments of polysomnography and patient-reported outcome measures (PROMs). Prespecified PROM endpoints were from baseline to Week 52. Changes in sleep-related impairment, sleep disturbance, excessive daytime sleepiness, functioning, and HRQoL were assessed using analysis of covariance. Categorical shifts in OSA symptom severity were described.ResultsAt Week 52, compared with placebo, tirzepatide-treated participants reported significantly improved Patient-Reported Outcomes Measurement Information System (PROMIS) Short-Form Sleep-related Impairment 8a scores, PROMIS Short-Form v1.0 Sleep Disturbance 8b scores, Functional Outcomes of Sleep Questionnaire Activity-Level scores, EQ-5D-5L scores, and most domains of the Short-Form 36 Health Survey, Version 2. Tirzepatide treatment was also associated with greater improvements in Patient Global Impression of Status and Patient Global Impression of Change symptom scales compared with placebo. Additionally, Study 1 participants reported significant changes in Epworth Sleepiness Scale scores.ConclusionResults indicate that in addition to objective outcomes of improved AHI, hypoxic burden associated with OSA, and cardiovascular risk factors, people with OSA reported benefits in symptoms, functioning, and HRQoL following tirzepatide treatment.ClinicaltrialsGov numberNCT05412004.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study8

8 results from studies that gave the peptide. 8 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In adults with moderate-to-severe obstructive sleep apnea and obesity, tirzepatide significantly improved the PROMIS Sleep-related Impairment score at Week 52 versus placebo.

    In plain wordsIn adults with sleep apnea and obesity, tirzepatide improved how much poor sleep affected daily life, compared with placebo.

    Peptide
    Tirzepatide
    Outcome
    DecreasePROMIS Sleep-related Impairment 8a score
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Sleep · Sleep
    Studied dose
    10 mg or 15 mg · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    At Week 52, compared with placebo, tirzepatide-treated participants reported significantly improved Patient-Reported Outcomes Measurement Information System (PROMIS) Short-Form Sleep-related Impairment 8a scores
    1 context sentence
    Summary · context
    SURMOUNT-OSA consisted of two randomized, placebo-controlled trials of tirzepatide (10 mg or 15 mg) or placebo for 52 weeks in participants with moderate-to-severe OSA and obesity.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In adults with moderate-to-severe obstructive sleep apnea and obesity, tirzepatide significantly improved the PROMIS Sleep Disturbance score at Week 52 versus placebo.

    In plain wordsIn adults with sleep apnea and obesity, tirzepatide improved reported sleep disturbance, compared with placebo.

    Peptide
    Tirzepatide
    Outcome
    DecreasePROMIS Sleep Disturbance 8b score
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Sleep · Sleep
    Studied dose
    10 mg or 15 mg · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    At Week 52, compared with placebo, tirzepatide-treated participants reported significantly improved
    2 context sentences
    Summary · context
    PROMIS Short-Form v1.0 Sleep Disturbance 8b scores
    Summary · context
    SURMOUNT-OSA consisted of two randomized, placebo-controlled trials of tirzepatide (10 mg or 15 mg) or placebo for 52 weeks in participants with moderate-to-severe OSA and obesity.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In adults with moderate-to-severe obstructive sleep apnea and obesity, tirzepatide significantly improved the FOSQ Activity-Level score at Week 52 versus placebo.

    In plain wordsIn adults with sleep apnea and obesity, tirzepatide improved the ability to be active despite sleepiness, compared with placebo.

    Peptide
    Tirzepatide
    Outcome
    IncreaseFunctional Outcomes of Sleep Questionnaire Activity-Level score
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Sleep · Sleep
    Studied dose
    10 mg or 15 mg · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    At Week 52, compared with placebo, tirzepatide-treated participants reported significantly improved
    2 context sentences
    Summary · context
    Functional Outcomes of Sleep Questionnaire Activity-Level scores
    Summary · context
    SURMOUNT-OSA consisted of two randomized, placebo-controlled trials of tirzepatide (10 mg or 15 mg) or placebo for 52 weeks in participants with moderate-to-severe OSA and obesity.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In adults with moderate-to-severe obstructive sleep apnea and obesity, tirzepatide significantly improved EQ-5D-5L scores at Week 52 versus placebo.

    In plain wordsIn adults with sleep apnea and obesity, tirzepatide improved health-related quality of life scores, compared with placebo.

    Peptide
    Tirzepatide
    Outcome
    IncreaseEQ-5D-5L score
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Quality of life · Whole body
    Studied dose
    10 mg or 15 mg · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    At Week 52, compared with placebo, tirzepatide-treated participants reported significantly improved
    2 context sentences
    Summary · context
    EQ-5D-5L scores, and most domains of the Short-Form 36 Health Survey, Version 2.
    Summary · context
    SURMOUNT-OSA consisted of two randomized, placebo-controlled trials of tirzepatide (10 mg or 15 mg) or placebo for 52 weeks in participants with moderate-to-severe OSA and obesity.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In adults with moderate-to-severe obstructive sleep apnea and obesity, tirzepatide significantly improved most domains of the Short-Form 36 Health Survey at Week 52 versus placebo.

    In plain wordsIn adults with sleep apnea and obesity, tirzepatide improved most areas of a general health survey, compared with placebo.

    Peptide
    Tirzepatide
    Outcome
    IncreaseShort-Form 36 Health Survey domains
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Quality of life · Whole body
    Studied dose
    10 mg or 15 mg · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    At Week 52, compared with placebo, tirzepatide-treated participants reported significantly improved
    2 context sentences
    Summary · context
    most domains of the Short-Form 36 Health Survey, Version 2.
    Summary · context
    SURMOUNT-OSA consisted of two randomized, placebo-controlled trials of tirzepatide (10 mg or 15 mg) or placebo for 52 weeks in participants with moderate-to-severe OSA and obesity.
  6. 06HumanRandomized controlled trialEfficacy outcome

    In adults with moderate-to-severe obstructive sleep apnea and obesity, tirzepatide was associated with greater improvements in Patient Global Impression of Status than placebo.

    In plain wordsIn adults with sleep apnea and obesity, patients on tirzepatide rated their symptom status as better than patients on placebo.

    Peptide
    Tirzepatide
    Outcome
    IncreasePatient Global Impression of Status
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Sleep · Sleep
    Studied dose
    10 mg or 15 mg · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    Tirzepatide treatment was also associated with greater improvements in Patient Global Impression of Status and Patient Global Impression of Change symptom scales compared with placebo.
    1 context sentence
    Summary · context
    SURMOUNT-OSA consisted of two randomized, placebo-controlled trials of tirzepatide (10 mg or 15 mg) or placebo for 52 weeks in participants with moderate-to-severe OSA and obesity.
  7. 07HumanRandomized controlled trialEfficacy outcome

    In adults with moderate-to-severe obstructive sleep apnea and obesity, tirzepatide was associated with greater improvements in Patient Global Impression of Change than placebo.

    In plain wordsIn adults with sleep apnea and obesity, patients on tirzepatide rated their symptom change as better than patients on placebo.

    Peptide
    Tirzepatide
    Outcome
    IncreasePatient Global Impression of Change
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Sleep · Sleep
    Studied dose
    10 mg or 15 mg · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    Tirzepatide treatment was also associated with greater improvements in Patient Global Impression of Status and Patient Global Impression of Change symptom scales compared with placebo.
    1 context sentence
    Summary · context
    SURMOUNT-OSA consisted of two randomized, placebo-controlled trials of tirzepatide (10 mg or 15 mg) or placebo for 52 weeks in participants with moderate-to-severe OSA and obesity.
  8. 08HumanRandomized controlled trialEfficacy outcome

    In Study 1 of SURMOUNT-OSA, participants on tirzepatide reported significant changes in Epworth Sleepiness Scale scores.

    In plain wordsIn one sleep apnea trial, people on tirzepatide reported a significant change in daytime sleepiness scores.

    Peptide
    Tirzepatide
    Outcome
    Not applicableEpworth Sleepiness Scale score in Study 1
    Study

    n: not reported in source

    Outcome group
    Sleep · Sleep
    Studied dose
    10 mg or 15 mg · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    Additionally, Study 1 participants reported significant changes in Epworth Sleepiness Scale scores.
    1 context sentence
    Summary · context
    SURMOUNT-OSA consisted of two randomized, placebo-controlled trials of tirzepatide (10 mg or 15 mg) or placebo for 52 weeks in participants with moderate-to-severe OSA and obesity.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT05412004

Obstructive Sleep Apnea Master Protocol GPIF: A Study of Tirzepatide (LY3298176) in Participants With Obstructive Sleep Apnea

Eli Lilly and Companyn = 46921 Jun 2022 to 29 Mar 2024

Obstructive Sleep Apnea · Obesity

Trial pageClinicalTrials.govUpdated 30 Apr 2025

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    12 Oct 2026, 12:58 UTC

    Study results updated

  2. Version 1

    9 Oct 2026, 03:07 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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