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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12625001391460
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
31/10/2025
Date registered
Help: Date registered
11/12/2025
Date last updated
Help: Date last updated
17/08/2026
Date data sharing statement initially provided
Help: Data sharing statement date
11/12/2025
Type of registration
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Prospectively registered

Titles & IDs
Public title
A Study of Tirzepatide’s Role in Affective and Neurobiological Dynamics (STRAND) in Binge Eating Disorder
Scientific title
Study of Tirzepatide’s Role in Affective and Neurobiological Dynamics (STRAND) Among Adults with Binge Eating Disorder (BED)
Additional trial identifiers [1] 315761 0
nil
Universal Trial Number (UTN)
Trial acronym
STRAND
Related trial records

Health condition
Health condition(s) studied:
Binge Eating Disorder 339500 0
Condition category
Condition code
Mental Health 335744 335744 0 0
Eating disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
The design of this study does not reflect that of a traditional clinical trial in that the aim is not to determine the effectiveness or efficacy of tirzepatide as treatment for binge eating disorder compared to other available treatments.

The primary outcome measure and secondary aims are centred on identifying how this medication may influence brain activity and how potential shifts in brain activity relate to BED behaviours.

The current research is designed to investigate changes in brain function and neural connectivity following tirzepatide administration in adults with a body mass index (BMI) over 30kg/m2 who also meet diagnostic criteria for Binge Eating Disorder. All participants in this study will receive the active intervention.

To assess potential neurobiological changes associated with tirzepatide use, participants will undergo functional magnetic resonance imaging (fMRI) at baseline (week 0, prior to the commencement of tirzepatide) and again at week 24 (following the completion of the tirzepatide dosing period). The change in brain activity associated with tirzepatide use is the primary outcome variable for this study.

Mode of Administration: Tirzepatide is self-administered subcutaneously once per week with a tirzeaptide KwikPen.
Dosage: Dosage gradually increases from 2.5 mg weekly to a maximum of 15 mg over 24 weeks. Dosage will be determined by changes in binge eating symptoms as measured by the Y-BOCS-BE
Adherence Monitoring: Usage will be monitored by monthly self report and return of tirzepatide KwikPens.
Intervention code [1] 332388 0
Treatment: Drugs
Description of the comparator or control
No control group

Each participant will have two fMRI scans (pre and post use of tirzepatide) where differences between brain activity will provide insight to the changes tirzepatide has on the brain.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 343530 0
To use functional magnetic resonance imaging (fMRI) to measure changes in brain connectivity following tirzepatide treatment
Timepoint [1] 343530 0
7T fMRI will be conducted at week zero (before tirzepatide administration) and week 24 (after 24 weeks of tirzepatide administration)
Secondary outcome [1] 453906 0
Composite Outcome: To examine how tirzepatide use over 24 weeks is related to changes in mood, thoughts, and eating behaviour. Participants will complete brief phone-based surveys about their emotions and eating urges throughout the study, and complete psychological questionnaires at the beginning and end of the study.
Timepoint [1] 453906 0
EMA prompts (four each day throughout weeks 0, 1, 5, 9, 13, 17 and 21) and daily diaries (one survey per day) on the remaining days of the study. The Y-BOCS-BE will be assessed at week 0 (baseline), week 1 (first tirzepatide administration) and weeks 5, 9, 13, 17 and 21. The ESPI, DASS21, FCQ-S, UPPS-P and PSQI will be assessed at baseline and week 24.

Eligibility
Key inclusion criteria
I1. Meet diagnostic criteria for binge eating disorder according to the M.I.N.I .

I2. Aged between 18 and 50.

I3. Have a BMI above 30 kg/m2 (max weight 120kg)

I4. Can provide written informed consent (including adequate intellectual capacity and fluency in the English language), as determined by the study research assistant.

I5. In the investigator's opinion, potential participants are well motivated, capable and willing to:
i. learn how to administer tirzepatide by the study protocol
ii. Follow study procedure throughout the term of the study (i.e. completing ecological monetary assessments, attend their scheduled appointments)
iii. Complete the MRI scanning protocol.

I6. has given informed consent to participate in this study following ethic procedures.

I7. Characteristics of participants whose sex assigned at birth is female:
i. participants assigned female at birth who are not of childbearing potential may participate including those who are:
a. infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy or tubal ligation), congenital anomaly such as Mullerian agenesis
b. postmenopausal, defined as a female at least 40 years of age with an intact uterus, not on hormone therapy and who has cessation of menses for at least 1 year without an alternative medical cause; women in this category must test negative in pregnancy test prior to study entry

ii. participants assigned female at birth who are of child-bearing potential (not surgically sterilized and between menarche and 1-year postmenopausal) must:
a. test negative for pregnancy at Visit 1 based on a serum pregnancy test and if sexually active
b. agree in writing to use 2 forms of effective contraception, where at least 1 form is highly effective, for the duration of the trial
c. not be breastfeeding.

I8. Have adequate English proficiency

I9. can provide the contact information of their general practitioner
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Exclusion Criteria include:

E1. Have type 1 diabetes mellitus (T1DM) and T2DM, history of ketoacidosis, or hyperosmolar state/coma

E2. Obesity-related:
i. Has a self-reported decrease in body weight >5kg within 3 months before screening
ii. Has had any prior or plan for future surgical treatment for obesity (excluding liposuction or abdominoplasty if performed >1 year prior to screening)
iii. Have or plan to have endoscopic and/or device-based therapy for obesity or have had device removal within the last 6 months (for example, mucosal ablation, gastric artery embolization, intragastric balloon and duodenal-jejunal bypass sleeve)
iv. Use (in the past 3 months) of medications intended to induce weight loss

E3. History of pancreatitis, uncontrolled hypertension or medullary thyroid cancer or multiple endocrine neoplasia syndrome type 2.

E4. Known or suspected allergy, serious hypersensitivity or contraindications to tirzepatide, lisdexamfetamine dimesylate, or any related compounds or excipients.

E5. have severe gastrointestinal disease

E6. Have known clinically significant renal impairment

E7. Have a lifetime history of psychostimulant abuse and/or dependence

E8. Have obesity induced by other endocrinologic disorders (for example, Cushing Syndrome) or diagnosed monogenetic or syndromic forms of obesity (for example, Melanocortin 4 Receptor deficiency or Prader Willi Syndrome)

E9. Neurological condition: has history of MS, TBI, stroke, epilepsy, migraines, seizures (other than infantile febrile seizures), any tic disorder, or a current diagnosis of Tourette's Disorder, history of significant head trauma, dementia, Parkinson's disease, or intracranial lesions etc. (Note: ADHD is not included in this exclusion criterion)

E10. Have a history of any other condition that may interfere with protocol adherence or study completion, as determined by the investigator.

E11. Have acute or chronic hepatitis, signs, and symptoms of any other liver disease other than non-alcoholic fatty liver disease.

E12. Have taken monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOIs

E13. Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy (other than basal- or squamous-cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) for less than 5 years

E14. Have used marijuana within 3 months prior to enrolment and are unwilling to abstain for the duration of the study.

E15. Have had a transplanted organ (corneal transplants [keratoplasty] allowed) or are awaiting an organ transplant.

E16. Participants taking tricyclic antidepressants and atypical antipsychotics (Note: Selective serotonin reuptake inhibitors other than paroxetine are permitted.)

E17. Meets diagnostic criteria as per the Mini-International Neuropsychiatric Interview (M.I.N.I.) for:
i. Agoraphobia impacting the participants ability to participate in study components
ii. Anti-social personality disorders
iii. Active suicidality within the last month (or is considered a suicide risk in the opinion of the researcher)
iv. Substance and/or alcohol use disorder within the past 5 years
v. Atypical anorexia nervosa (current)
vi. unstable major depressive disorder (MDD) or unstable general anxiety disorder (GAD). Note, patients with MDD or generalised anxiety disorder whose disease state is considered stable and expected to remain stable throughout the course of the study, in the opinion of the investigator, may be considered for inclusion if not on excluded medications.
Vii. Obsessive Compulsive Disorder (OCD)
Viii. Psychotic disorders

E18. MRI contraindications: Medical conditions or implanted devices that make it unsafe for a person to undergo MRI scanning. These include, but are not limited to, metal implants (e.g., pacemakers, cochlear implants, aneurysm clips), metallic fragments, and certain surgical hardware. Participants with any such contraindications will be excluded from the MRI component of the study

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2026
Actual
3/03/2026
Date of last participant enrolment
Anticipated
1/06/2029
Actual
Date of last data collection
Anticipated
3/12/2029
Actual
Sample size
Target
60
Accrual to date
11
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 320371 0
University
Name [1] 320371 0
University of Melbourne
Country [1] 320371 0
Australia
Funding source category [2] 320372 0
Government body
Name [2] 320372 0
National Health and Medical Research Council (NHMRC)
Country [2] 320372 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Country
Australia
Secondary sponsor category [1] 322961 0
None
Name [1] 322961 0
Address [1] 322961 0
Country [1] 322961 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318917 0
Science, Technology, Engineering, Mathematics and Medicine (STEMM 1)- Greater Than Low Risk (GTLR) committee
Ethics committee address [1] 318917 0
Ethics committee country [1] 318917 0
Australia
Date submitted for ethics approval [1] 318917 0
11/06/2025
Approval date [1] 318917 0
22/09/2025
Ethics approval number [1] 318917 0

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

Contacts
Principal investigator
Name 145662 0
Dr Trevor Streward
Address 145662 0
Level 3, 161 Barry St, The University of Melbourne, Carlton VIC 3053
Country 145662 0
Australia
Phone 145662 0
+61 3 8344 5509
Fax 145662 0
Email 145662 0
[email protected]
Contact person for public queries
Name 145663 0
Lucy Nathan
Address 145663 0
Level 3, 161 Barry St, The University of Melbourne, Carlton VIC 3053
Country 145663 0
Australia
Phone 145663 0
+61 3 8344 5509
Fax 145663 0
Email 145663 0
[email protected]
Contact person for scientific queries
Name 145664 0
Trevor Streward
Address 145664 0
Level 3, 161 Barry St, The University of Melbourne, Carlton VIC 3053
Country 145664 0
Australia
Phone 145664 0
+61 3 8344 5509
Fax 145664 0
Email 145664 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
• Published results
• Primary outcome(s)
• Safety 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:
At the end of the study
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Data repository: The data repository will be established after the study conclusion. For interim queries regarding data requests, please contact the PI Dr. Trevor Steward (email: [email protected]; Ph: +6183445509)



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.