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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05412004
Registration number
NCT05412004
Ethics application status
Date submitted
25/05/2022
Date registered
9/06/2022
Date last updated
30/05/2024
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:
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 Maximum Tolerated Dose - Participants will receive a low dose and then increase to a maximum tolerated dose 1 or dose 2 subcutaneously (SC).
GPI1: Participants are unwilling or unable to use PAP therapy.
GPI2: Participants are on PAP therapy.
Placebo Comparator: Placebo - Participants will receive placebo SC
GPI1: Participants are unwilling or unable to use PAP therapy.
GPI2: Participants are on PAP therapy.
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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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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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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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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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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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) Sleep-Related Impairment Short Form 8a and PROMIS Sleep Disturbance Short Form 8b
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Assessment method [5]
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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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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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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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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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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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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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Niedersachsen
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Germany
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Germany
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Schleswig-Holstein
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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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Japan
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Tokyo
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Distrito Federal
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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 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/ct2/show/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
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05412004
Download to PDF