Acute Metabolic Effects of Tirzepatide in Type 1 Diabetes
Launched by GARVAN INSTITUTE OF MEDICAL RESEARCH · Feb 6, 2025
Trial Information
Current as of November 10, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at how a medication called Tirzepatide affects metabolism in people with Type 1 Diabetes (T1D). Tirzepatide is a new type of treatment that helps manage blood sugar levels by working on hormones that control insulin and appetite. Participants in the study will have their insulin sensitivity and hormone levels measured before and after four weeks of using Tirzepatide. The results will be compared to a group of adults without diabetes to see how metabolism differs between those with and without T1D.
To be eligible for this trial, participants must be between 18 and 55 years old, have a body mass index (BMI) of 27 or higher, and have been diagnosed with Type 1 Diabetes for at least two years. They should also be using an automated insulin delivery system and have a controlled blood sugar level. However, certain health conditions and recent treatments might disqualify someone from participating. If eligible, participants can expect to take Tirzepatide for four weeks and undergo several tests to monitor their metabolic response. It’s important to know that the trial is not yet recruiting, so those interested will need to wait until it starts.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • age 18-55 years
- • BMI ≥ 27 kg/m2
- • HbA1c ≤ 9.0%
- • insulin delivery using an automated insulin delivery system
- • at least 2 years since diagnosis of type 1 diabetes
- Exclusion Criteria:
- • TZP or GLP-1 receptor agonist in last 3 months; metformin or sodium glucose co-transporter 2 (SGLT2) inhibitor in the last 6 weeks; steroids, antipsychotics, immunosuppressants in the last 6 weeks.
- • Hypoglycemic unawareness or severe hypoglycemia last 6 months.
- • History of seizure disorder.
- • History of weight loss surgery.
- • eGFR \<60 mL/min/1.73 m2.
- • Liver disease (known cirrhosis, LFTs \> 3x upper limit of normal).
- • Active malignancy.
- • Pregnant, breastfeeding, planning pregnancy within 6 months, or not using adequate contraception.
- • History of cardiovascular disease, or coronary event or stroke in last 3 months
- • Hemoglobin level \< 13.5 g/dL
About Garvan Institute Of Medical Research
The Garvan Institute of Medical Research is a leading Australian medical research organization dedicated to advancing our understanding of health and disease through innovative research. Located in Sydney, the Institute focuses on a range of areas including cancer, diabetes, obesity, and mental health, employing cutting-edge technologies and multidisciplinary approaches to drive discoveries that translate into improved patient outcomes. With a commitment to collaboration and excellence, Garvan aims to bridge the gap between laboratory findings and clinical applications, fostering a transformative impact on global health through its clinical trials and research initiatives.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Sydney, New South Wales, Australia
Patients applied
Trial Officials
Jennifer R Snaith, MD PHD
Principal Investigator
Garvan Institute of Medical Research
Jerry R Greenfield, MD PHD
Study Director
Garvan Institute of Medical Research
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported