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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05412004
Registration number
NCT05412004
Ethics application status
Date submitted
25/05/2022
Date registered
9/06/2022
Date last updated
30/04/2025
Titles & IDs
Public title
Obstructive Sleep Apnea Master Protocol GPIF: A Study of Tirzepatide (LY3298176) in Participants With Obstructive Sleep Apnea
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Scientific title
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
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Secondary ID [1]
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I8F-MC-GPIF
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Secondary ID [2]
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18357
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Universal Trial Number (UTN)
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Trial acronym
SURMOUNT-OSA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnea
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Obesity
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Condition category
Condition code
Respiratory
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Sleep apnoea
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Diet and Nutrition
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Obesity
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Metabolic and Endocrine
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Other metabolic disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Tirzepatide
Treatment: Drugs - Placebo
Experimental: Tirzepatide MTD_GPI1 - Participants not on positive airway pressure (PAP) therapy received a maximum tolerated dose (MTD) of 10 milligrams (mg) or 15 mg of Tirzepatide once weekly (QW) as a subcutaneous (SC) injection for 52 weeks, including the initial dose escalation by 2.5 mg every 4 weeks
Placebo comparator: Placebo_GPI1 - Participants not on PAP therapy received placebo QW as an SC injection for 52 weeks.
Experimental: Tirzepatide MTD_GPI2 - Participants who are on PAP therapy received an MTD of 10 mg or 15 mg of Tirzepatide QW as an SC injection for 52 weeks, including the initial dose escalation by 2.5 mg every 4 weeks
Placebo comparator: Placebo_GPI2 - Participants who are on PAP therapy received placebo QW as an SC injection for 52 weeks.
Treatment: Drugs: Tirzepatide
Administered SC
Treatment: Drugs: Placebo
Administered SC
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline in Apnea-Hypopnea Index (AHI)
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline, Week 52
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Secondary outcome [1]
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Percent Change From Baseline in Apnea-Hypopnea Index (AHI)
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Assessment method [1]
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Percent Change From Baseline in AHI was evaluated.
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Timepoint [1]
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Baseline, Week 52
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Secondary outcome [2]
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Percentage of Participants With =50% AHI Reduction From Baseline
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Assessment method [2]
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Percentage of participants achieving =50% AHI reduction from baseline to Week 52 was evaluated.
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Timepoint [2]
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Week 52
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Secondary outcome [3]
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Percentage of Participants With AHI <5 or With AHI 5-14 With Epworth Sleepiness Scale (ESS) =10
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Assessment method [3]
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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.
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Timepoint [3]
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Week 52
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Secondary outcome [4]
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Change From Baseline in Sleep Apnea-Specific Hypoxic Burden (SASHB) (% Min/Hour)
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline, Week 52
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Secondary outcome [5]
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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)
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Assessment method [5]
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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).
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Timepoint [5]
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Baseline, Week 52
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Secondary outcome [6]
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Percent Change From Baseline in Body Weight
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Assessment method [6]
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Percent Change from Baseline in Body Weight was evaluated.
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Timepoint [6]
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Baseline, Week 52
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Secondary outcome [7]
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Change From Baseline in High Sensitivity C Reactive Protein (hsCRP) Concentration
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Assessment method [7]
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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.
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Timepoint [7]
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Baseline, Week 52
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Secondary outcome [8]
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Change From Baseline in Systolic Blood Pressure (SBP)
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Assessment method [8]
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Change in systolic blood pressure from baseline to Week 48 was evaluated.
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Timepoint [8]
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Baseline, Week 48
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Eligibility
Key inclusion criteria
For GPI1 Participants:
- Participants who are unable or unwilling to use PAP therapy. Participants must not have used PAP for at least 4 weeks prior to screening.
For GPI2 Participants:
- Have been on PAP therapy for at least 3 consecutive months prior to screening and plan to continue PAP therapy during the study
For Both GPI1 and GPI2 Participants:
* Have an AHI =15 on PSG as part of the trial at screening
* Have a body mass index (BMI) =30 kilogram/square meter (kg/m²)
* Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
For GPI2 Participants:
* Have personal or job-related responsibilities, or in the opinion of the investigator have any situation, that would make it unsafe to stop PAP therapy for 7 days prior to PSG testing during the course of the study
* Are unwilling to stop PAP therapy for 7 days prior to polysomnography (PSG) testing during the course of the study
For GPI1 and GPI2 Participants:
* Female participants must not be pregnant, intending to be pregnant, breastfeeding, or intending to breastfeed.
* Have type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM), history of ketoacidosis, or hyperosmolar state/coma.
* Have HbA1c = 6.5% (= 48 mmol/mol) at baseline
* Any previous or planned surgery for sleep apnea or major ear, nose or throat surgery, including tonsillectomy and adenoidectomy that still may affect breathing at time of baseline
* Have significant craniofacial abnormalities that may affect breathing at baseline
* Have diagnosis of Central or Mixed Sleep Apnea with % of mixed or central apneas/hypopneas =50%, or diagnosis of Cheyne Stokes Respiration
* Diagnosis of Obesity Hypoventilation Syndrome or daytime hypercapnia.
* Active device treatment of OSA other than PAP therapy (for example, dental appliance), or other treatment, that in the opinion of the investigator, may interfere with study outcomes, unless willing to stop treatment at baseline and throughout the study.
* Respiratory and neuromuscular diseases that could interfere with the results of the trial in the opinion of the investigator.
* Have a self-reported change in body weight >5 kg within 3 months prior to screening
* Have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty if performed more than 1 year prior to screening)
* Have or plan to have endoscopic and/or device-based therapy for obesity or have had device removal within the last 6 months (for example, mucosal ablation, gastric artery embolization, intragastric balloon, and duodenal-jejunal bypass sleeve)
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
21/06/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
29/03/2024
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Sample size
Target
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Accrual to date
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Final
469
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Recruitment in Australia
Recruitment state(s)
NSW,SA
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Recruitment hospital [1]
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Woolcock Institute of Medical Research - Sydney
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Recruitment hospital [2]
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Flinders University - Bedford Park
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Recruitment postcode(s) [1]
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2037 - Sydney
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Recruitment postcode(s) [2]
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5042 - Bedford Park
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Recruitment outside Australia
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United States of America
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California
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Florida
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United States of America
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Georgia
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Idaho
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Indiana
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North Dakota
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Ohio
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Pennsylvania
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Texas
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Washington
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Brazil
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Rio Grande Do Sul
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Brazil
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São Paulo
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China
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Jiangsu
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China
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Jilin
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China
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Shanghai
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China
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Sichuan
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China
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Tianjin
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Czechia
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Praha 2
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Czechia
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Niedersachsen
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Germany
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Germany
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Germany
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Berlin
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Germany
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Hamburg
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Aichi
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Fukuoka
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Kanagawa
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Japan
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Osaka
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Tokyo
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Distrito Federal
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Jalisco
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Nuevo León
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Veracruz
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Hato Rey
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Taichung
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Taiwan
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Tainan
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Eli Lilly and Company
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT05412004
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
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Address
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Eli Lilly and Company
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Contact person for public queries
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
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When will data be available (start and end dates)?
Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
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Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: http://vivli.org/
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What supporting documents are/will be available?
No Supporting Document Provided
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Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/04/NCT05412004/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/04/NCT05412004/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT05412004
Download to PDF