Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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.
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.
Secondary ID [1] 314204 0
Pilot WLM
Secondary ID [2] 314625 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 337101 0
Condition category
Condition code
Metabolic and Endocrine 333521 333521 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 330808 0
Treatment: Drugs
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.
Control group
Dose comparison

Outcomes
Primary outcome [1] 341097 0
Proportion of participants who have experienced weight maintenance during follow up, defined as gaining no more than 2kg at week 24 from randomisation
Timepoint [1] 341097 0
Week 24 from randomisation.
Secondary outcome [1] 446216 0
Feasibility
Timepoint [1] 446216 0
At 24 weeks post-intervention commencement
Secondary outcome [2] 446217 0
Weight change (kg and %)
Timepoint [2] 446217 0
At each 4-weekly study visit until 24-weeks post intervention commencement.
Secondary outcome [3] 446218 0
Patient-reported outcomes
Timepoint [3] 446218 0
At each 4-weekly study visit until 24-weels post intervention commencement
Secondary outcome [4] 448630 0
Changes in systolic and diastolic blood pressure
Timepoint [4] 448630 0
Measured blood pressure at each 4-weekly study visit until 24-weeks post intervention commencement
Secondary outcome [5] 448631 0
Biochemical outcomes: fasting plasma glucose, lipid profile (total cholesterol, triglycerides, LDL, HDL)
Timepoint [5] 448631 0
At baseline and at 24-weeks post intervention commencement.

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Planned bariatric surgery during follow-up
Clinical indication for continuation of weekly dosing

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)
sealed opaque envelopes
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)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
23/06/2025
Actual
Date of last participant enrolment
Anticipated
26/06/2026
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 318721 0
University
Name [1] 318721 0
Monash University
Country [1] 318721 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Country
Australia
Secondary sponsor category [1] 321156 0
None
Name [1] 321156 0
Address [1] 321156 0
Country [1] 321156 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317333 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 317333 0
Ethics committee country [1] 317333 0
Australia
Date submitted for ethics approval [1] 317333 0
03/03/2025
Approval date [1] 317333 0
09/04/2025
Ethics approval number [1] 317333 0

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

Contacts
Principal investigator
Name 140714 0
A/Prof Priya Sumithran
Address 140714 0
Monash University, Level 6, 99 Commercial Road, Melbourne VIC 3004
Country 140714 0
Australia
Phone 140714 0
+61 0399038939
Fax 140714 0
Email 140714 0
[email protected]
Contact person for public queries
Name 140715 0
Damien Qi
Address 140715 0
Monash University, Level 6, 99 Commercial Road, Melbourne VIC 3004
Country 140715 0
Australia
Phone 140715 0
+61 0399030555
Fax 140715 0
Email 140715 0
[email protected]
Contact person for scientific queries
Name 140716 0
Priya Sumithran
Address 140716 0
Monash University, Level 6, 99 Commercial Road, Melbourne VIC 3004
Country 140716 0
Australia
Phone 140716 0
+61 0399038939
Fax 140716 0
Email 140716 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?
• De-identified individual participant data:
• 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 [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.