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Acute Metabolic Effects of Tirzepatide in Type 1 Diabetes

RECRUITINGPhase 2Sponsored by Victor Chang Cardiac Research Institute
Actively Recruiting
PhasePhase 2
SponsorVictor Chang Cardiac Research Institute
Started2026-07-07
Est. completion2027-12-31
Eligibility
Age18 Years – 70 Years
Healthy vol.Accepted

Summary

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.

Eligibility

Age: 18 Years – 70 YearsHealthy volunteers accepted
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

Conditions2

DiabetesType 1 Diabetes Mellitus

Interventions2

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