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Clinical Trial
. 2025 Oct:134:106719.
doi: 10.1016/j.sleep.2025.106719. Epub 2025 Aug 6.

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

Chisom Kanu  1 , Shraddha Shinde  2 , Sujatro Chakladar  2 , Ellen B Dennehy  2 , Terri E Weaver  3 , Jiat Ling Poon  2 , Atul Malhotra  4
Affiliations
Clinical Trial

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

Chisom Kanu et al. Sleep Med. 2025 Oct.

Abstract

Aim: In 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.

Methods: 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. For participants using PAP (Study 2), PAP was withdrawn prior to assessments of polysomnography and patient-reported outcome measures (PROMs).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.

Results: 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, 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.

Conclusion: Results 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.

Gov number: NCT05412004.

Keywords: Functional status; Health-related quality of life; Obesity; Obstructive sleep apnea; Patient-reported outcomes.

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Conflict of interest statement

Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests:Chisom Kanu, Shraddha Shinde, Jiat Ling Poon, Ellen Dennehy, and Sujatro Chakladar are employees and stockholders of Eli Lilly and Company, USA. Terri E Weaver has served as a consultant/advisory board member from the Alkermes Orexin Advisory Board, Bayer AG, Eli Lilly and Company, and the Idorsia Alliance for Sleep; and has received royalty fees for use of the FOSQ from Alkermes, Axsome Therapeutics, Bayer AG, Bioprojet Deutschland GmbH, Eli Lilly and Company, Harmony Biosciences, Ignis Therapeutics (Shanghai) Ltd., Inspire Medical Systems, IQVIA Technologies, Jazz Pharmaceuticals, LivaNova, Nyxoah, Philips Respironics, ResMed, Signant Health, Signifier Medical Technologies, Stratevi, Syneos Health, Vallis Bioscience, and Verily Life Sciences. Atul Malhotra is funded by the National Institutes of Health and has received income related to medical education from Eli Lilly and Company, Jazz Pharmaceuticals, LivaNova, and Zoll Medical; ResMed provided a philanthropic donation to the University of California San Diego where he is employed.

Figures

Fig. 1.
Fig. 1.
Change in patient-reported sleep disturbance and sleep-related impairment assessed by change in PROMIS-SD and PROMIS-SRI scores from baseline to Week 52 Abbreviations: CI, confidence interval; diff, difference; LSM, least squares mean; MTD, maximum tolerated dose, n, total number of patients with non-missing data at that particular timepoint; PROMIS-SRI, Patient-Reported Outcomes Measurement Information System Short-Form Sleep-related Impairment 8a; PROMI Data presented are least-square means derived using analysis of covariance with multiple imputation of missing values. The analysis included the full analysis set for the treatment-regimen estimand. **p-value <0.01, *p-value <0.05 versus placebo.
Fig. 2.
Fig. 2.
Forest plot of the treatment differences from baseline to Week 52 for the ESS, FOSQ, EQ-5D-5L, and SF-36 v2 acute form PROMs Abbreviations: CI, confidence interval; diff, difference; EQ-5D-5L, EQ-5D-5 Level; EQ-VAS, EQ -Visual Analog Scale; ESS, Epworth Sleepiness Scale; FOSQ, Functional Outcomes of Sleep Questionnaire; LSM, least squares mean; MTD, maximum tolerated dose; PROM, patient-reported outcome measures; SF-36 v2, Short-Form-36 Health Survey, Version 2; TZP, tirzepatide. Data presented are LSM change differences (95 % CI) for TZP MTD versus placebo derived using analysis of covariance with multiple imputation of missing values. The analysis included the full analysis set for the treatment-regimen estimand. Please refer to the Supplementary figures for the number of participants included in each PROM analysis.
Fig. 3.
Fig. 3.
Shift plots of PGIS scales at Week 52 Abbreviations: MTD, maximum tolerated dose; n, number of participants in the population with baseline and postbaseline value; PGIS-OSA, Patient Global Impression of Status – Obstructive Sleep Apnea; TZP, tirzepatide.
Fig. 4.
Fig. 4.
Shift plots of PGIC scales at Week 52 Abbreviations: MTD, maximum tolerated dose; n, number of participants in the population with baseline and postbaseline value; PGIC-OSA, Patient Global Impression of Change – Obstructive Sleep Apnea; TZP, tirzepatide.
See this image and copyright information in PMC

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