None listed
Conditions
Brief summary
This study investigates how tirzepatide affects brain activity in adults with binge eating disorder (BMI > 30 kg/m²). Tirzepatide (Mounjaro) is a GLP-1/GIP receptor agonist that lowers blood sugar and supports weight loss by regulating insulin and appetite. Although approved by the TGA for type 2 diabetes, weight management, and obstructive sleep apnoea, it has not been approved for binge eating disorder. Limited evidence suggests similar drugs may reduce binge-eating episodes. The study aims to examine changes in brain activity after 24 weeks of tirzepatide use and explore how daily and questionnaire data relate to these neurobiological changes.
Interventions
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 f
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.
Sponsors
University of Melbourne
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Healthy volunteers
No
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 125kg). 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
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 change 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 past 3 months of medications to induce weight loss, including GLP-1 receptor agonists. 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 and/or known family history 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 ii. Anti-social personality disorders iii. Bipolar disorder iv. Active suicidality within the last month (or is considered a suicide risk in the opinion of the researcher) v. Substance and/or alcohol use disorder within the past 5 years vi. Atypical anorexia nervosa vii. 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. 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
Outcome results
None listed