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Trial registered on ANZCTR
Registration number
ACTRN12625000609459
Ethics application status
Approved
Date submitted
15/04/2025
Date registered
12/06/2025
Date last updated
12/06/2025
Date data sharing statement initially provided
12/06/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
Alternate-weekly medication dosing for weight maintenance.
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Scientific title
A phase 2 randomised, open-label trial of maintenance of weight loss with alternate-weekly incretin medication dosing in adults currently taking semaglutide or tirzepatide for obesity management.
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Secondary ID [1]
314204
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Pilot WLM
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Secondary ID [2]
314625
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Obesity
337101
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Condition category
Condition code
Metabolic and Endocrine
333521
333521
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0
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Metabolic disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Semaglutide or tirzepatide administered at reduced frequency (fortnightly) for 24 weeks.
The dose administered every fortnight will be the numerical weekly dose at recruitment, but given every fortnight rather than weekly.
Subcutaneous injection.
Adherence based on self-report.
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Intervention code [1]
330808
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Treatment: Drugs
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Comparator / control treatment
The control group will continue their weekly medication dosage at recruitment,
Semaglutide at a minimum dose of 1.0mg weekly.
Tirzepatide at a minimum dose of 5.0mg weekly.
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Control group
Dose comparison
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Outcomes
Primary outcome [1]
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Proportion of participants who have experienced weight maintenance during follow up, defined as gaining no more than 2kg at week 24 from randomisation
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Assessment method [1]
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Measured weight at randomisation and at week 24 using a consistent weighing scale.
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Timepoint [1]
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Week 24 from randomisation.
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Secondary outcome [1]
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Feasibility
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Assessment method [1]
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Determining the ability for this new dosing regimen to maintain weight and prevent weight regain based on the proportion of individuals who gain no more than 2kg at study completion as measured by a consistent weighing scale.
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Timepoint [1]
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At 24 weeks post-intervention commencement
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Secondary outcome [2]
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Weight change (kg and %)
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Assessment method [2]
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Weighing scale at each 4-weekly study visit until 24-weeks post intervention commencement.
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Timepoint [2]
446217
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At each 4-weekly study visit until 24-weeks post intervention commencement.
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Secondary outcome [3]
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Patient-reported outcomes
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Assessment method [3]
446218
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Control of eating (Control of Eating Questionnaire)
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Timepoint [3]
446218
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At each 4-weekly study visit until 24-weels post intervention commencement
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Secondary outcome [4]
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Changes in systolic and diastolic blood pressure
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Assessment method [4]
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Automated device measuring systolic and diastolic blood pressure
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Timepoint [4]
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Measured blood pressure at each 4-weekly study visit until 24-weeks post intervention commencement
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Secondary outcome [5]
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Biochemical outcomes: fasting plasma glucose, lipid profile (total cholesterol, triglycerides, LDL, HDL)
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Assessment method [5]
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Blood test at baseline and at 24-weeks post intervention commencement.
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Timepoint [5]
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At baseline and at 24-weeks post intervention commencement.
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Eligibility
Key inclusion criteria
Age 18 years or older
Currently taking once-weekly semaglutide or tirzepatide for weight management, at a stable dose
Has lost greater than or equal to 10% total body weight during current weight loss attempt
Stable weight leading up to enrolment
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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
Planned bariatric surgery during follow-up
Clinical indication for continuation of weekly dosing
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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)
sealed opaque envelopes
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
23/06/2025
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Actual
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Date of last participant enrolment
Anticipated
26/06/2026
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Actual
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Date of last data collection
Anticipated
31/12/2026
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Actual
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Sample size
Target
30
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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Monash University
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Address [1]
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Country [1]
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Australia
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Primary sponsor type
University
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Name
Monash University
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
321156
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Address [1]
321156
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Country [1]
321156
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
317333
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Alfred Hospital Ethics Committee
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Ethics committee address [1]
317333
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https://www.alfredhealth.org.au/research/ethics-research-governance
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Ethics committee country [1]
317333
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Australia
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Date submitted for ethics approval [1]
317333
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03/03/2025
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Approval date [1]
317333
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09/04/2025
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Ethics approval number [1]
317333
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Summary
Brief summary
The overall aim of this study is to establish the feasibility of a treatment approach using alternate-weekly dosing of incretin medication for weight maintenance after weight loss.
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Trial website
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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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A/Prof Priya Sumithran
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Address
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Monash University, Level 6, 99 Commercial Road, Melbourne VIC 3004
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Country
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Australia
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Phone
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+61 0399038939
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Fax
140714
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Email
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Priya.Sumithran@monash.edu
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Contact person for public queries
Name
140715
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Damien Qi
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Address
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Monash University, Level 6, 99 Commercial Road, Melbourne VIC 3004
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Country
140715
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Australia
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Phone
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+61 0399030555
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Fax
140715
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Email
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Qi.Qi@monash.edu
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Contact person for scientific queries
Name
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Priya Sumithran
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Address
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Monash University, Level 6, 99 Commercial Road, Melbourne VIC 3004
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Country
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Australia
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Phone
140716
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+61 0399038939
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Fax
140716
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Email
140716
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Priya.Sumithran@monash.edu
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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:
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Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
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Requires a scientifically sound proposal or protocol
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Requires approval by an ethics committee
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Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
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De-identified individual participant data:
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All outcomes 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:
12 months after publication
To:
A finite period of:
4
years
Where can requests to access individual participant data be made, or data be obtained directly?
•
Email of trial custodian, sponsor or committee:
Email request to priya.sumithran@monash.edu
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.
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