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Trial registered on ANZCTR


Registration number
ACTRN12624001278527p
Ethics application status
Submitted, not yet approved
Date submitted
12/09/2024
Date registered
18/10/2024
Date last updated
18/10/2024
Date data sharing statement initially provided
18/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of tirzepatide on asthma control in obese asthmatics
Scientific title
Effect of tirzepatide on asthma control in obese asthmatics aged 16 years and over: A phase III randomised double blinded placebo control trial
Secondary ID [1] 312956 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Asthma
 335128 0
Obesity 335203 0
Metabolic Syndrome 335204 0
Condition category
Condition code
Respiratory 331628 331628 0 0
Asthma
Metabolic and Endocrine 331629 331629 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Tirzepatide 2.5mg administered subcutaneously weekly
First dose administered under supervision, all subsequent doses to be self-administered
Assessment for tolerability at 4 weeks
If no grade 2 or 3 side effects, then dose escalation by 2.5mg to;
5mg administered subcutaneously weekly
Assessment at 4 weeks as above
Dose escalation will occur in a similar fashion, every 4 weeks until a maximum dose of 10mg is achieved

Assessment of compliance completed monthly with either phone or face-to-face assessment. Trial participants will be asked directly regarding medical compliance. Any noncompliance will be recorded by the clinical trial officer.

Total duration of treatment will be 36 weeks
Intervention code [1] 329489 0
Treatment: Drugs
Comparator / control treatment
Placebo as a subcutaneous injection of 0.9% normal saline.
Syringe will be visually exactly the same as the active drug syringe.
Control group
Placebo

Outcomes
Primary outcome [1] 339362 0
Asthma control
Timepoint [1] 339362 0
ACQ6 will be taken at baseline, week 16, and at week 36 (end of trial)
Secondary outcome [1] 439653 0
Weight change
Timepoint [1] 439653 0
Collected at baseline, week 16 post baseline and at 36 weeks post baseline
Secondary outcome [2] 439654 0
Blood pressure recorded in mmHg
Timepoint [2] 439654 0
Collected at baseline, week 16 post baseline and at 36 weeks post baseline
Secondary outcome [3] 439655 0
Urine metabolomics - exploratory outcome measure
A range of inflammatory and nutritional metabolites
Recorded as a composite outcome
Timepoint [3] 439655 0
Collected at baseline and at 36 weeks post baseline
Secondary outcome [4] 439656 0
Adiponectin
Timepoint [4] 439656 0
Collected at baseline and at 36 weeks post baseline
Secondary outcome [5] 439657 0
Leptin
Timepoint [5] 439657 0
Collected at baseline and at 36 weeks post baseline
Secondary outcome [6] 439658 0
Insulin
Timepoint [6] 439658 0
Collected at baseline and at 36 weeks post baseline
Secondary outcome [7] 439659 0
Fasting blood glucose
Timepoint [7] 439659 0
Collected at baseline and at 36 weeks post baseline
Secondary outcome [8] 439660 0
HbA1c - glycated haemoglobin
Timepoint [8] 439660 0
Collected at baseline and at 36 weeks post baseline
Secondary outcome [9] 439661 0
Serum myeloperoxidase (MPO)
Timepoint [9] 439661 0
Collected at baseline and at 36 weeks post baseline
Secondary outcome [10] 439856 0
Calprotectin
Timepoint [10] 439856 0
Collected at baseline and at 36 weeks post baseline
Secondary outcome [11] 439857 0
Interleukin 10 - IL-10
Assessed with bioplex assay
Timepoint [11] 439857 0
Collected at baseline and at 36 weeks post baseline
Secondary outcome [12] 439858 0
Interleukin 6 - IL-6
Assessed with bioplex assay
Timepoint [12] 439858 0
Collected at baseline and at 36 weeks post baseline
Secondary outcome [13] 439859 0
interleukin - IL-33
Timepoint [13] 439859 0
Collected at baseline and at 36 weeks post baseline
Secondary outcome [14] 439860 0
Soluble IL-6 receptor
Timepoint [14] 439860 0
Collected at baseline and at 36 weeks post baseline
Secondary outcome [15] 439861 0
TNF- alpha - tumor necrosis factor alpha
Timepoint [15] 439861 0
Collected at baseline and at 36 weeks post baseline
Secondary outcome [16] 439862 0
AQLQ – Asthma quality of life questionnaire
Timepoint [16] 439862 0
Collected at baseline, at 16 weeks post baseline and at 36 weeks post baseline
Secondary outcome [17] 439863 0
HADS – Hospital anxiety and depression score as a composite outcome
Timepoint [17] 439863 0
Collected at baseline, at 16 weeks post baseline and at 36 weeks post baseline
Secondary outcome [18] 439864 0
GSRS – gastrointestinal symptom rating scale
Timepoint [18] 439864 0
Collected at baseline, at 16 weeks post baseline and at 36 weeks post baseline
Secondary outcome [19] 439865 0
ESS - Epworth sleepiness score
Timepoint [19] 439865 0
Collected at baseline, at 16 weeks post baseline and at 36 weeks post baseline
Secondary outcome [20] 439866 0
Food frequency questionnaire Australian Eating Survey
(https://australianeatingsurvey.com.au/ )
Timepoint [20] 439866 0
Collected at baseline and at 36 weeks post baseline
Secondary outcome [21] 439867 0
Exploratory outcome - Stool sample for microbiome assessment
Timepoint [21] 439867 0
Collected at baseline and at 36 weeks post baseline
Secondary outcome [22] 439868 0
Exploratory outcome - record device physical activity in steps (if available)
Timepoint [22] 439868 0
Collected at baseline (3 months retrospective data extracted) and at 36 weeks post baseline (3 months retrospective data extracted)
Secondary outcome [23] 439869 0
Optional Investigation and exploratory outcome
Airway microscopy, culture and sensitivity - as a composite outcome
Timepoint [23] 439869 0
Collected at baseline and at 36 weeks post baseline
Secondary outcome [24] 439870 0
Optional Investigation and exploratory outcome
Airway IL-5
Timepoint [24] 439870 0
Collected at baseline and at 36 weeks post baseline
Secondary outcome [25] 439871 0
Optional Investigation and exploratory outcome
Airway GLP-1 receptor quantitative assessment
Timepoint [25] 439871 0
Collected at baseline and at 36 weeks post baseline
Secondary outcome [26] 439872 0
Optional Investigation and exploratory outcome - composite outcome
Airway - cell differential - eosinophils, macrophages, neutrophils, lymphocytes
Timepoint [26] 439872 0
Collected at baseline and at 36 weeks post baseline
Secondary outcome [27] 439873 0
Optional Investigation and exploratory outcome
Airway sub mucosal eosinophil assessment
Timepoint [27] 439873 0
Collected at baseline and at 36 weeks post baseline
Secondary outcome [28] 439874 0
Optional Investigation and exploratory outcome
Subcutaneous adipose tissue biopsy for assessment of tissue inflammation and metabolism
Timepoint [28] 439874 0
Collected at baseline and at 36 weeks post baseline
Secondary outcome [29] 439875 0
Optional Investigation and exploratory outcome measure - composite outcome
Subcutaneous adipose tissue biopsy looking at immune cells including eosinophils lymphocytes and macrophages
Timepoint [29] 439875 0
Collected at baseline and at 36 weeks post baseline
Secondary outcome [30] 439876 0
Lung function changes - spirometry
Assessment of severity of any airflow obstruction
Timepoint [30] 439876 0
Collected at baseline and at 36 weeks post baseline
Secondary outcome [31] 439877 0
Lung function assessment - spirometry
Timepoint [31] 439877 0
Collected at baseline and at 36 weeks post baseline
Secondary outcome [32] 439878 0
Lung function assessment - spirometry
Assessment for airway obstruction
Timepoint [32] 439878 0
Collected at baseline and at 36 weeks post baseline
Secondary outcome [33] 439879 0
Lung function
Assessment for airway inflammation assessment
Timepoint [33] 439879 0
Collected at baseline and at 36 weeks post baseline
Secondary outcome [34] 439880 0
Lung function exploratory outcome
Timepoint [34] 439880 0
Collected at baseline and at 36 weeks post baseline

Eligibility
Key inclusion criteria
All patients
>16 years and over
Physician diagnosed asthma
Mild / moderate / severe
Partially controlled asthma (ACQ6 > 0.75)
BMI > 30
Able and willing to consent
Speak and understand English
Be able to attend study appointments
Agree to have blood tests, lung function, participate in questionnaires and food diary
Willing for us to access their smart devices for activity assessment
Willing to use contraception if women of childbearing age
Being treated with optimised guideline based conventional asthma care as per global initiative for asthma guidelines (GINA)
Can be on all standard of care asthma treatment including advanced therapies
Stratification for metabolic syndrome
Minimum age
16 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria
Unable / unwilling to consent
Currently using a glucagon like peptide - one (GLP-1) agonist
Regular use of illicit substances
Contraindication or intolerance to glucagon like peptide - one (GLP-1) agonists treatment in the past
Specific for glucagon like peptide - one (GLP-1) agonists
Patients with type 1 diabetes
Taking insulin for type 2 diabetes mellitus (T2DM)
Taking sulphonylurea
History of acute pancreatitis
Pregnancy or plans of becoming pregnant

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)
Randomisation will be conducted by the research pharmacy off site using a predetermined electronic randomising program integrated with drug preparation and delivery
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
For the primary outcome of change in ACQ6 between baseline and 36 weeks, group sizes of 20 (treatment) and 20 (Placebo) would achieve 80% power to detect an effect size (Cohen’s d = mean/SD) of 0.91 (large effect size) using a two-sample t-test and choosing an alpha of 0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/06/2025
Actual
Date of last participant enrolment
Anticipated
28/12/2026
Actual
Date of last data collection
Anticipated
6/09/2027
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 27092 0
Mater Hospital Brisbane - South Brisbane
Recruitment postcode(s) [1] 43166 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 317387 0
Charities/Societies/Foundations
Name [1] 317387 0
Betty McGrath Seeding Grant
Country [1] 317387 0
Australia
Funding source category [2] 317453 0
Hospital
Name [2] 317453 0
Mater respiratiry, infectious disease and oncology clinical trials unit
Country [2] 317453 0
Australia
Primary sponsor type
Hospital
Name
Mater Hospital
Address
Country
Australia
Secondary sponsor category [1] 319679 0
University
Name [1] 319679 0
University of Queensland
Address [1] 319679 0
Country [1] 319679 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316115 0
Mater Misericordiae Ltd Human Research Ethics Committee
Ethics committee address [1] 316115 0
Ethics committee country [1] 316115 0
Australia
Date submitted for ethics approval [1] 316115 0
17/09/2024
Approval date [1] 316115 0
Ethics approval number [1] 316115 0

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

Contacts
Principal investigator
Name 136838 0
Dr Adrian Barnett
Address 136838 0
Mater Hospital South Brisbane, Raymond Terrace, Queensland, 4101
Country 136838 0
Australia
Phone 136838 0
+61 0410415414
Fax 136838 0
Email 136838 0
[email protected]
Contact person for public queries
Name 136839 0
Adrian Barnett
Address 136839 0
Mater Hospital South Brisbane, Raymond Terrace, Queensland, 4101
Country 136839 0
Australia
Phone 136839 0
+61 0410415414
Fax 136839 0
Email 136839 0
[email protected]
Contact person for scientific queries
Name 136840 0
Adrian Barnett
Address 136840 0
Mater Hospital South Brisbane, Raymond Terrace, Queensland, 4101
Country 136840 0
Australia
Phone 136840 0
+61 0410415414
Fax 136840 0
Email 136840 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.