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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
View on ClinicalTrials.gov →
NCT06820281
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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Actively Recruiting
PhasePhase 2
SponsorVictor Chang Cardiac Research Institute
Started2026-07-07
Est. completion2027-12-31
Eligibility
Age18 Years – 70 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT06820281