Acute Metabolic Effects of Tirzepatide in Type 1 Diabetes
Recruiting · NCT06820281 · Interventional (participants receive a specific treatment) · Lead sponsor: Victor Chang Cardiac Research Institute
View the official record on ClinicalTrials.gov →Interventions studied
Placebo injection (normal saline)Tirzepatide 2.5mg weekly
What this trial is about
This study will examine the effects of Tirzepatide (TZP), a glucagon-like peptide 1 (GLP1) - gastric inhibitory peptide (GIP) co-agonist, on metabolism in type 1 diabetes (T1D). Research participants with T1D will undergo measures of insulin sensitivity, and hormone levels post-meal, post-hypoglycemia and during the overnight period. These measures will be performed prior to, and after 6 weeks of treatment with TZP or placebo.
Who can take part
Age range
18 Years to 70 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- age 18-70 years
- BMI ≥ 25 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; systemic steroids, antipsychotics, 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.
- Coronary event or stroke in last 6 months
- Active or untreated proliferative diabetic retinopathy
- Hemoglobin level \< 13.5 g/dL in men, \< 12.0 g/dL in women
Where it is running
1 location listed.
- Victor Chang Cardiac Research Institute - Sydney, New South Wales, Australia