The purpose of this study is to evaluate the effect and safety of tirzepatide in participants with moderate to severe obstructive sleep apnea and obesity who are both unwilling or unable to use Positive Airway Pressure (PAP) therapy in GPI1 and those who are and plan to stay on PAP therapy in GPI2.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
469
Administered SC
Administered SC
Change From Baseline in Apnea-Hypopnea Index (AHI)
AHI, Apnea-Hypopnea Index, is the number of apneas or hypopneas recorded via polysomnography during the study per hour of sleep. Apnea is defined as a cessation of airflow lasting at least 10 seconds, hypopnea as a decrease in airflow by at least 30% from baseline for at least 10 seconds occurring with a drop in oxygen saturation (SpO₂) by at least 4%. AHI values are categorized as 5-15 events/hr = mild; 15-\<30 events/hr = moderate; and ≥ 30 events/hr = severe. a significant reduction in values indicates a positive outcome.
Time frame: Baseline, Week 52
Percent Change From Baseline in Apnea-Hypopnea Index (AHI)
Percent Change From Baseline in AHI was evaluated.
Time frame: Baseline, Week 52
Percentage of Participants With ≥50% AHI Reduction From Baseline
Percentage of participants achieving ≥50% AHI reduction from baseline to Week 52 was evaluated.
Time frame: Week 52
Percentage of Participants With AHI <5 or With AHI 5-14 With Epworth Sleepiness Scale (ESS) ≤10
The percentage of participants with OSA remission (AHI \<5 events per hour of sleep) or with mild OSA without excessive daytime sleepiness (AHI 5-14 events per hour of sleep with ESS ≤10) at Week 52 was evaluated. The ESS is used to assess improvements in excessive daytime sleepiness from baseline to Week 52. The ESS is an 8-item, participant-completed measure that asks the participant to rate, on a scale of 0 (no chance of dozing) to 3 (high chance of dozing), their usual chances of dozing in 8 different daytime situations, with a recall period of "in recent times." The ESS total score is the sum of the 8-item scores and ranges from 0 to 24, with higher scores indicating greater daytime sleepiness.
Time frame: Week 52
Change From Baseline in Sleep Apnea-Specific Hypoxic Burden (SASHB) (% Min/Hour)
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Artemis Institute for Clinical Research
Riverside, California, United States
Teradan Clinical Trials, LLC
Brandon, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
Palm Beach Research Center
West Palm Beach, Florida, United States
NeuroTrials Research Inc
Atlanta, Georgia, United States
Rocky Mountain Clinical Research
Idaho Falls, Idaho, United States
Brengle Family Medicine
Indianapolis, Indiana, United States
Lillestol Research
Fargo, North Dakota, United States
NeuroScience Research Center
Canton, Ohio, United States
CTI-CRC
Cincinnati, Ohio, United States
...and 48 more locations
SASHB was determined by measuring the respiratory event-associated area under the curve for oxygen desaturation from pre-event baseline and represents the cumulative burden of intermittent hypoxia caused by OSA-related sleep-disordered breathing at sleep.
Time frame: Baseline, Week 52
Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Short Form Sleep-Related Impairment 8a (PROMIS SRI) and PROMIS Short Form Sleep Disturbance 8b (PROMIS SD)
PROMIS SRI consists of 8 items that assess self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours and perceived functional impairments associated with sleep problems. PROMIS SRI has a recall period of "in the past 7 days" and each item is rated on a 5-point scale from "not at all" to "very much." PROMIS SD consists of 8 items that assess self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. PROMIS SD has a recall period of "in the past 7 days" and each item is rated on a 5-point scale ranging from "not at all" to "very much," "never" to "always," or "very poor" to "very good." For both PROMIS SRI and PROMIS SD, item responses are used to generate T-scores which are standardized scores with a mean of 50 and a standard deviation of 10 (score range cannot be specified for T-scores). Higher T-scores indicate worse outcomes; more sleep-related impairment (PROMIS SRI) or more sleep disturbance (PROMIS SD).
Time frame: Baseline, Week 52
Percent Change From Baseline in Body Weight
Percent Change from Baseline in Body Weight was evaluated.
Time frame: Baseline, Week 52
Change From Baseline in High Sensitivity C Reactive Protein (hsCRP) Concentration
HsCRP is a marker for inflammation and was measured from blood samples to identify the presence of inflammation, to determine its severity, and to monitor response to treatment.
Time frame: Baseline, Week 52
Change From Baseline in Systolic Blood Pressure (SBP)
Change in systolic blood pressure from baseline to Week 48 was evaluated.
Time frame: Baseline, Week 48