Not Yet RecruitingPhase 2

Acute Metabolic Effects of Tirzepatide in Type 1 Diabetes

Australia44 participantsStarted 2025-12-01

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * age 18-65 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 in men, \< 12.0 g/dL in women

What they're measuring

Whole-body insulin sensitivity

Timeframe: 6 weeks

Trial details

NCT IDNCT06820281

SponsorGarvan Institute of Medical Research

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-31

Contact for this trial

Jennifer R Snaith, MD PHD

+61 2 9295 8600 j.snaith@victorchang.edu.au