Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000979459p
Ethics application status
Submitted, not yet approved
Date submitted
9/08/2025
Date registered
5/09/2025
Date last updated
5/09/2025
Date data sharing statement initially provided
5/09/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the efficacy of an injectable weight loss medication to prevent diabetes and reduce cardiovascular disease risk in the Aboriginal population of Western Australia
Scientific title
Evaluating the efficacy of an injectable incretin agonist to prevent diabetes and reduce cardiovascular disease risk in the Aboriginal population of Western Australia
Secondary ID [1] 315087 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Prevent D-CVD A Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 338483 0
Condition category
Condition code
Metabolic and Endocrine 334786 334786 0 0
Metabolic disorders
Metabolic and Endocrine 334787 334787 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Semaglutide 0.25 mg subcutaneous injection weekly administered by healthcare professional and uptitrating every 4 weeks to 0.5 mg weekly, 1 mg weekly, 1.7 mg weekly and to a maximum of 2.4 mg weekly as tolerated; total duration of treatment will be 52 weeks. This will be in addition to background lifestyle support. Initial dietary education will occur as a 1 hour group session (up to 10 participants) led by a dietitician, which will be followed by sessions every three months at community centres led by a trained Aboriginal Health Worker. 1 hour exercise classes will be running weekly at the community centre supervised by. an exercise physiologist or physiotherapist so that participants are provided with a personalised exercise plan. These exercise classes may include a combination of aerobic and anaerobic exercises. Weekly check in duration of 15 minutes will occur one-on-one face-to-face with an Aboriginal Health Worker at the community centre, who will check on any side-effects, general well-being, and administer the injection.
Intervention code [1] 331701 0
Treatment: Drugs
Comparator / control treatment
Subcutaneous injection with matching volume of normal saline plus background lifestyle support as intervention group.
Control group
Placebo

Outcomes
Primary outcome [1] 342425 0
Body weight reduction 10% or more.
Timepoint [1] 342425 0
Baseline and 52 weeks post-commencement of intervention
Secondary outcome [1] 450755 0
Fat mass
Timepoint [1] 450755 0
Baseline and 52 weeks post-commencement of intervention
Secondary outcome [2] 450756 0
Non-calcified coronary atheroma volume
Timepoint [2] 450756 0
Baseline and 52 weeks post-commencement of intervention
Secondary outcome [3] 450757 0
7-day continuous glucose profiles.
Timepoint [3] 450757 0
Baseline and 52 weeks post-commencement of intervention
Secondary outcome [4] 450758 0
Waist circumference
Timepoint [4] 450758 0
Baseline and 52 weeks post-commencement of intervention
Secondary outcome [5] 450759 0
Blood pressure
Timepoint [5] 450759 0
Baseline and 52 weeks post-commencement of intervention
Secondary outcome [6] 450760 0
Lipid profile
Timepoint [6] 450760 0
Baseline and 52 weeks post-commencement of intervention
Secondary outcome [7] 450761 0
Fasting glucose level
Timepoint [7] 450761 0
Baseline and 52 weeks post-commencement of intervention
Secondary outcome [8] 450762 0
Coronary artery calcium score
Timepoint [8] 450762 0
Baseline and 52 weeks post-commencement of intervention
Secondary outcome [9] 450763 0
Lean mass
Timepoint [9] 450763 0
Baseline and 52 weeks post-commencement of intervention
Secondary outcome [10] 450764 0
Quality of life
Timepoint [10] 450764 0
Baseline and 52 weeks post-commencement of intervention
Secondary outcome [11] 450765 0
Food choices
Timepoint [11] 450765 0
Baseline and 52 weeks post-commencement of intervention
Secondary outcome [12] 451376 0
Glycated haemoglobin
Timepoint [12] 451376 0
Baseline and 52 weeks post-commencement of intervention
Secondary outcome [13] 451377 0
Insulin level
Timepoint [13] 451377 0
Baseline and 52 weeks post-commencement of intervention
Secondary outcome [14] 451378 0
Plaque composition
Timepoint [14] 451378 0
Baseline and 52 weeks post-commencement of intervention
Secondary outcome [15] 451379 0
High-risk coronary plaque characteristics
Timepoint [15] 451379 0
Baseline and 52 weeks post-commencement of intervention
Secondary outcome [16] 451380 0
Peri-coronary adipose tissue attenuation
Timepoint [16] 451380 0
Baseline and 52 weeks post-commencement of intervention
Secondary outcome [17] 451381 0
Epicardial fat
Timepoint [17] 451381 0
Baseline and 52 weeks post-commencement of intervention

Eligibility
Key inclusion criteria
Aboriginal or Torres Strait Islander person aged 30-60 years with body mass index (BMI) =>30 kg/m2 or aged 18-30 years with BMI =>30 kg/m2 plus at least one other cardiovascular risk factor (e.g., hypertension, diabetes or dyslipidaemia, smoking, or family history of cardiovascular disease).
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Prior use of agent targeting glucaon-like peptide-1 (GLP-1) receptor or GLP-1 and gastric inhibitory polypeptide (GIP) receptors.
• Type 2 diabetes requiring more than oral glucose-lowering therapies.
• Type 1 diabetes.
• Prior or planned bariatric/metabolic surgery for weight loss.
• Known significant gastric emptying abnormality (e.g., gastroparesis or gastric outlet obstruction).
• Known severe coronary artery disease or prior myocardial infarction.
• Known active or untreated malignancy or in remission from a clinically significant malignancy.
• Other major medical comorbidities which may complicate participation in the study.
• History of acute or chronic pancreatitis.
• Excessive alcohol consumption.
• Severe mental health condition.
• History of multiple endocrine neoplasia syndrome (MEN) type 2 or medullary thyroid carcinoma.
• Renal impairment with an estimated glomerular filtration rate of <30 ml/min/1.73m2.
• Known iodinated contrast anaphylaxis.
• Inability to provide informed consent.
• Pregnant or breastfeeding women.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
2/02/2026
Actual
Date of last participant enrolment
Anticipated
30/06/2027
Actual
Date of last data collection
Anticipated
29/12/2028
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 319659 0
Self funded/Unfunded
Name [1] 319659 0
Country [1] 319659 0
Primary sponsor type
University
Name
The University of Western Australia
Address
Country
Australia
Secondary sponsor category [1] 322161 0
None
Name [1] 322161 0
Address [1] 322161 0
Country [1] 322161 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 318221 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 318221 0
Ethics committee country [1] 318221 0
Australia
Date submitted for ethics approval [1] 318221 0
25/03/2024
Approval date [1] 318221 0
Ethics approval number [1] 318221 0
Ethics committee name [2] 318222 0
Western Australian Aboriginal Health Ethics Committee
Ethics committee address [2] 318222 0
Ethics committee country [2] 318222 0
Australia
Date submitted for ethics approval [2] 318222 0
05/03/2024
Approval date [2] 318222 0
Ethics approval number [2] 318222 0

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

Contacts
Principal investigator
Name 143482 0
Prof Bu Yeap
Address 143482 0
Medical School, The University of Western Australia, 35 Stirling Hwy, Crawley WA 6009
Country 143482 0
Australia
Phone 143482 0
+61861511149
Fax 143482 0
Email 143482 0
[email protected]
Contact person for public queries
Name 143483 0
Nick Lan
Address 143483 0
Medical School, The University of Western Australia, 35 Stirling Hwy, Crawley WA 6009
Country 143483 0
Australia
Phone 143483 0
+61861511246
Fax 143483 0
Email 143483 0
[email protected]
Contact person for scientific queries
Name 143484 0
Nick Lan
Address 143484 0
Medical School, The University of Western Australia, 35 Stirling Hwy, Crawley WA 6009
Country 143484 0
Australia
Phone 143484 0
+61861511246
Fax 143484 0
Email 143484 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.