Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001332314
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
6/10/2026
Date registered
Help: Date registered
5/11/2026
Date last updated
Help: Date last updated
5/11/2026
Date data sharing statement initially provided
Help: Data sharing statement date
5/11/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the effect of semaglutide on the heart in adults with obesity and previous cardiovascular disease.
Scientific title
Effects of Semaglutide on Myocardial Energetics in People with Obesity: A Pilot-Prospective Mechanistic Study
Additional trial identifiers [1] 318456 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Pilot SEMA-Obesity
Related trial records

Health condition
Health condition(s) studied:
Obesity 343630 0
Cardiovascular disease 343869 0
Condition category
Condition code
Cardiovascular 339741 339741 0 0
Coronary heart disease
Cardiovascular 339742 339742 0 0
Diseases of the vasculature and circulation including the lymphatic system
Stroke 339743 339743 0 0
Ischaemic
Diet and Nutrition 340012 340012 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Arm 1:
- Semaglutide 0.5mg weekly by subcutaneous injection for 6 weeks, participant self administration. Adherence measured by number of missed doses at each study visit.
- Brief behavioural advice delivered by researcher (Endocrinologist) during face-to-face appointment (Visit 1) including dietary and exercise recommendations, with behavioural strategies for weight management (consume a wide variety of unprocessed foods together with an aim of 30 minutes or greater of moderate physical activity per day, no specific materials will be provided)
- 3 study visits.
Visit 1 (study commencement) approximately 2 hour appointment with study doctor (Endocrinologist) involving consent, randomisation, anthropometric measurements, blood tests, and advanced MRI scan,
Visit 2 (at week 3) approximately 30 minute appointment with study doctor (Endocrinologist) to measure weight, blood pressure, medication adherence, and adverse events.
Visit 3 (at week 6, study conclusion) approximately 2 hour appointment with study doctor (Endocrinologist) involving anthropometric measurements, blood tests, and advanced MRI scan,
Intervention code [1] 335366 0
Treatment: Drugs
Intervention code [2] 335556 0
Treatment: Other
Description of the comparator or control
Arm 2:
- Low energy diet for 6 weeks with use of 1-2 optifast shakes for meal replacement, aiming for approximately 1,000-1,200 calories per day
- Dietary advice provided by researcher (Endocrinologist) during face-to-face appointment (Visit 1) detailing calorie intake with meal replacement and provision of education regarding further intake and associated calorie content (no specific materials used)
- 3 study visits.
Visit 1 (study commencement) approximately 2 hour appointment with study doctor (Endocrinologist) involving consent, randomisation, anthropometric measurements, blood tests, and advanced MRI scan,
Visit 2 (at week 3) approximately 30 minute appointment with study doctor (Endocrinologist) to measure weight, blood pressure, medication adherence, and adverse events.
Visit 3 (at week 6, study conclusion) approximately 2 hour appointment with study doctor (Endocrinologist) involving anthropometric measurements, blood tests, and advanced MRI scan,
Control group
Active

Outcomes
Primary outcome [1] 346912 0
Myocardial energetics (PCr/ATP)
Timepoint [1] 346912 0
6 weeks post intervention commencement
Secondary outcome [1] 468118 0
Myocardial perfusion
Timepoint [1] 468118 0
6 weeks post intervention commencement
Secondary outcome [2] 468119 0
Metabolic outcome - body weight
Timepoint [2] 468119 0
6 weeks post intervention commencement
Secondary outcome [3] 468120 0
Metabolic outcome - blood pressure
Timepoint [3] 468120 0
6 weeks post intervention commencement
Secondary outcome [4] 468875 0
Metabolic outcome - fasting plasma glucose
Timepoint [4] 468875 0
6 weeks post intervention commencement
Secondary outcome [5] 469260 0
Feasibility
Timepoint [5] 469260 0
Assessed at the conclusion of the study
Secondary outcome [6] 469261 0
Metabolic outcome - high sensitivity C-reactive protein
Timepoint [6] 469261 0
6 weeks post intervention commencement
Secondary outcome [7] 469666 0
Feasibility
Timepoint [7] 469666 0
Assessed at the conclusion of the study

Eligibility
Key inclusion criteria
• Aged 45 years or greater
• Body Mass Index of 27 kg/m2 or greater
• Established cardiovascular disease defined as previous myocardial infarction, previous stroke, or previous/current symptomatic peripheral arterial disease
• Willing to be randomised to either treatment arm
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
• Type 2 diabetes diagnosed according to the World Health Organisation criteria or glycated haemoglobin of 6.5% or greater at screening
• Symptomatic angina – within the preceding 12 weeks
• Moderate or worsening valvular heart disease
• Cardiovascular or neurological event within the preceding 12 weeks
• Planned to undergo coronary, carotid, or peripheral revascularisation during study period
• Contraindications to CMR including known hypersensitivity to adenosine or gadolinium
• Chronic kidney disease stage 4 or 5 (estimated glomerular filtration rate <30 mL/min/1.73 m2)
• Current or recent (within 12 weeks of recruitment) treatment with any incretin hormone agonist
• Commencement on any new medication or change in dose of current medication for CV risk factor modification in the preceding 12 weeks
• A history of pancreatitis or medullary thyroid cancer/multiple endocrine neoplasia type 2
• Previous bariatric surgery or use of any medications for weight management within the preceding 12 weeks
• A positive serum beta-HCG test consistent with pregnancy
• A history of metal injury or metal in situ precluding the ability to have CMR performed

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)
Central randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated random sequence
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
As a pilot study, no power calculation was performed. 20 participants with overweight/obesity will be recruited to estimate effect sizes and variability for myocardial oxygenation, perfusion, energetics, as well as attrition over 6 weeks, to inform a subsequent definitive clinical trial. Statistical analyses will be conducted on a completer basis with blinded assessment, reporting between-group differences with 95% confidence intervals and two-sided hypothesis testing.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
9/11/2026
Actual
Date of last participant enrolment
Anticipated
1/09/2027
Actual
Date of last data collection
Anticipated
30/10/2027
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 323038 0
University
Name [1] 323038 0
Monash University
Country [1] 323038 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Country
Australia
Secondary sponsor category [1] 325983 0
None
Name [1] 325983 0
Address [1] 325983 0
Country [1] 325983 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 321443 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 321443 0
Ethics committee country [1] 321443 0
Australia
Date submitted for ethics approval [1] 321443 0
15/01/2026
Approval date [1] 321443 0
09/09/2026
Ethics approval number [1] 321443 0

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

Contacts
Principal investigator
Name 153742 0
A/Prof Priya Sumithran
Address 153742 0
School of Translational Medicine, Monash University, Level 6, Alfred Centre, 99 Commercial Rd, Melbourne 3004, VIC
Country 153742 0
Australia
Phone 153742 0
+61 3 9903 8939
Fax 153742 0
Email 153742 0
[email protected]
Contact person for public queries
Name 153743 0
Damien Qi
Address 153743 0
School of Translational Medicine, Monash University, Level 6, Alfred Centre, 99 Commercial Rd, Melbourne 3004, VIC
Country 153743 0
Australia
Phone 153743 0
+61415570979
Fax 153743 0
Email 153743 0
[email protected]
Contact person for scientific queries
Name 153744 0
Priya Sumithran
Address 153744 0
School of Translational Medicine, Monash University, Level 6, Alfred Centre, 99 Commercial Rd, Melbourne 3004 VIC
Country 153744 0
Australia
Phone 153744 0
+61 3 9903 8939
Fax 153744 0
Email 153744 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• All de-identified individual participant data
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to 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.