Status:
NOT_YET_RECRUITING
Tirzepatide for the Treatment of Concurrent Type 1 Diabetes and Overweight or Obesity
Lead Sponsor:
Royal North Shore Hospital
Conditions:
Type 1 Diabetes Mellitus
Overweight and Obesity
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This study is a 2-arm, double blinded, randomised clinical trial where 40 participants will be assigned 1:1 to insulin treatment alone (control) or insulin treatment and tirzepatide treatment for 32 w...
Eligibility Criteria
Inclusion
- Age 18-70 years at screening
- A clinical diagnosis of T1D for at least 12 months at time of screening
- Body mass index ≥ 27kg/m2
- HbA1c ≤ 10%
- Capable and willing to self-inject tirzepatide once per week
- In women of childbearing potential, a negative pregnancy test and willing to use effective contraception consistently for the duration of the study
- Able and willing to provide written informed consent for study participation
- Able and willing to use Easy Diet Diary
- Able and willing to keep an exercise log
- Willing to share devices data uploads
- Has current glucagon product to treat severe hypoglycaemia
- Has current ketone meters to check ketones
Exclusion
- Age \<18 years and \>70 years
- A clinical diagnosis of diabetes type other than T1D
- HbA1c \> 10%
- Use of GLP-1 receptor agonist within 1 month of study screening
- Use of any glucose lowering medications aside from insulin within 1 month of study screening
- History of hypersensitivity to investigational medicinal product or related product
- Obesity that is induced by other endocrine disorders
- Pregnancy or positive pregnancy test at time of screening, or unwilling to use effective contraception consistently for the duration of the study which is defined in Appendix 1
- Active proliferative diabetic retinopathy, maculopathy, or severe no proliferative diabetic retinopathy requiring acute treatment
- Known gastric emptying abnormality
- History of chronic or acute pancreatitis, uncontrolled hypertension, acute cardiovascular condition within 3 months
- No longer than 12 months of insulin treatment
- Not willing to use a NovoPen 6 to record insulin dosing if currently using multiple daily injections
- Insulin pump, CGM or smart phone devices are not compatible for data transfer
- Not willing to share device data
- Current use of any steroidal medication, or planned long-term steroidal treatment (\>4 weeks) during the study period
- Serum triglycerides \>500 mg/dL
- History of or plans for bariatric surgery during the study period
- eGFR \<45 ml/min/1.73 m2
- History of severe hypoglycaemia (within 3 months of trial period)
- History of diabetic ketoacidosis (within 3 months of trial period)
- History of stroke (within 3 months of trial period)
- History of heart failure
- Planned coronary, carotid, or peripheral artery revascularisation
- History of acute or chronic liver disease
- History of allergy to any form of insulin, GLP-1RA or its excipients
- History of malignancy requiring chemotherapy, surgery, or radiation (within 5 years of trial period)
- History of multiple endocrine neoplasia type 2, familial thyroid cancer, or non-familial medullary thyroid cancer
- Presence or history of malignant neoplasms or in situ carcinomas (other than basal or squamous cell skin cancer, low-risk prostate cancer, or in situ carcinomas of the cervix or carcinoma in situ/high grade prostatic intraepithelial neoplasia) within 5 years before screening
- Have a pacemaker, or metal implants
- Participation in other intervention trials during the study period
- Existence of any additional health conditions or medical issues, including significant psychiatric disorders, that render a person unfit for the study at the discretion of the investigators
Key Trial Info
Start Date :
December 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06180616
Start Date
December 1 2026
End Date
December 1 2028
Last Update
July 29 2025
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