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Search / Trial NCT06820281

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

Diabetes Mellitus, Type 1 Diabetes Mellitus Autoimmune Diseases Incretins Physiological Effects Of Drugs Tirzepatide Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Overnutrition Insulin Resistance

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.

Locations

Sydney, New South Wales, Australia

Patients applied

0 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