Tirzepatide for the Treatment of Concurrent Type 1 Diabetes and Overweight or Obesity (TZP-T1D)

Royal North Shore Hospital

Status and phase

Begins enrollment in 1 month

Phase 2

Conditions

Type 1 Diabetes Mellitus

Overweight and Obesity

Treatments

Drug: Tirzepatide

Study type

Interventional

Funder types

Other

Identifiers

NCT06180616

TZP-T1D

Details and patient eligibility

About

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 weeks. The primary objective is to demonstrate that tirzepatide treatment, dose incremented to 15mg QW for 32 weeks adjunctive to insulin treatment can reduce body weight in patients with T1D and overweight or obesity when compared to insulin treatment alone. The secondary objective is to demonstrate that tirzepatide treatment, dose incremented to 15mg QW for 32 weeks can improve glycaemic control (measured by hbA1c), improve time in range, reduce insulin requirements, and reduce the severity of comorbidities in people with obesity and T1D. This trial includes a 6 month follow-up period.

Enrollment

40 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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