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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

Titles & IDs
Public title
Obstructive Sleep Apnea Master Protocol GPIF: A Study of Tirzepatide (LY3298176) in Participants With Obstructive Sleep Apnea
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
Secondary ID [1] 0 0
I8F-MC-GPIF
Secondary ID [2] 0 0
18357
Universal Trial Number (UTN)
Trial acronym
SURMOUNT-OSA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep Apnea 0 0
Obesity 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Sleep apnoea
Diet and Nutrition 0 0 0 0
Obesity
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from Baseline in Apnea-Hypopnea Index (AHI)
Timepoint [1] 0 0
Baseline, Week 52
Secondary outcome [1] 0 0
Percent Change from Baseline in Apnea-Hypopnea Index (AHI)
Timepoint [1] 0 0
Baseline, Week 52
Secondary outcome [2] 0 0
Percentage of Participants with =50% AHI Reduction from Baseline
Timepoint [2] 0 0
Week 52
Secondary outcome [3] 0 0
Percentage of Participants with AHI <5 or with AHI 5-14 with Epworth Sleepiness Scale (ESS) =10
Timepoint [3] 0 0
Week 52
Secondary outcome [4] 0 0
Change from Baseline in Sleep Apnea-Specific Hypoxic Burden (SASHB) (% min/hour)
Timepoint [4] 0 0
Baseline, Week 52
Secondary outcome [5] 0 0
Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep-Related Impairment Short Form 8a and PROMIS Sleep Disturbance Short Form 8b
Timepoint [5] 0 0
Baseline, Week 52
Secondary outcome [6] 0 0
Percent Change from Baseline in Body Weight
Timepoint [6] 0 0
Baseline, Week 52
Secondary outcome [7] 0 0
Change from Baseline in High Sensitivity C reactive Protein (hsCRP) Concentration
Timepoint [7] 0 0
Baseline, Week 52
Secondary outcome [8] 0 0
Change from Baseline in Systolic Blood Pressure (SBP)
Timepoint [8] 0 0
Baseline, Week 48

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/06/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
29/03/2024
Sample size
Target
Accrual to date
Final
469
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 0 0
Woolcock Institute of Medical Research - Sydney
Recruitment hospital [2] 0 0
Flinders University - Bedford Park
Recruitment postcode(s) [1] 0 0
2037 - Sydney
Recruitment postcode(s) [2] 0 0
5042 - Bedford Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Idaho
Country [5] 0 0
United States of America
State/province [5] 0 0
Indiana
Country [6] 0 0
United States of America
State/province [6] 0 0
North Dakota
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
United States of America
State/province [10] 0 0
Washington
Country [11] 0 0
Brazil
State/province [11] 0 0
Rio Grande Do Sul
Country [12] 0 0
Brazil
State/province [12] 0 0
São Paulo
Country [13] 0 0
China
State/province [13] 0 0
Jiangsu
Country [14] 0 0
China
State/province [14] 0 0
Jilin
Country [15] 0 0
China
State/province [15] 0 0
Shanghai
Country [16] 0 0
China
State/province [16] 0 0
Sichuan
Country [17] 0 0
China
State/province [17] 0 0
Tianjin
Country [18] 0 0
Czechia
State/province [18] 0 0
Praha 2
Country [19] 0 0
Czechia
State/province [19] 0 0
Praha 5
Country [20] 0 0
Germany
State/province [20] 0 0
Niedersachsen
Country [21] 0 0
Germany
State/province [21] 0 0
Nordrhein-Westfalen
Country [22] 0 0
Germany
State/province [22] 0 0
Schleswig-Holstein
Country [23] 0 0
Germany
State/province [23] 0 0
Berlin
Country [24] 0 0
Germany
State/province [24] 0 0
Hamburg
Country [25] 0 0
Japan
State/province [25] 0 0
Aichi
Country [26] 0 0
Japan
State/province [26] 0 0
Fukuoka
Country [27] 0 0
Japan
State/province [27] 0 0
Kanagawa
Country [28] 0 0
Japan
State/province [28] 0 0
Osaka
Country [29] 0 0
Japan
State/province [29] 0 0
Tokyo
Country [30] 0 0
Mexico
State/province [30] 0 0
Distrito Federal
Country [31] 0 0
Mexico
State/province [31] 0 0
Jalisco
Country [32] 0 0
Mexico
State/province [32] 0 0
Nuevo León
Country [33] 0 0
Mexico
State/province [33] 0 0
Chihuahua
Country [34] 0 0
Mexico
State/province [34] 0 0
Veracruz
Country [35] 0 0
Puerto Rico
State/province [35] 0 0
Hato Rey
Country [36] 0 0
Taiwan
State/province [36] 0 0
Taichung
Country [37] 0 0
Taiwan
State/province [37] 0 0
Tainan

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
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)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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)
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.
Available to whom?
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://vivli.org/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05412004