Clinical trial

Acute Metabolic Effects of Tirzepatide in Type 1 Diabetes

Recruiting now · Phase 2 · 1 countries · Registry ID NCT06820281

Recruiting nowPhase 2Interventional

What this study 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years

SexAll

Healthy volunteersNot accepted

ConditionType 1 Diabetes Mellitus

Full registry criteria

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

Treatments and study arms

Tirzepatide 2.5mg weekly

Drug

Tirzepatide 2.5 mg/0.5 mL solution for injection vial or pre-filled pen. Each vial/ pre-filled pen contains tirzepatide 2.5 mg in 0.5 mL solution (2.5mg in 0.6mL if Kwikpen) Tirzepatide will be administered by drawing up into a syringe, then administering by subcutaneous injection weekly by study nurses.

Placebo injection (normal saline)

Drug

Placebo will be given as 0.5mL normal saline (if comparator against vial or pre-filled pen), or 0.6mL (if comparator against Mounjaro Kwikpen), drawn up into a syringe and administered by subcutaneous injection weekly by study nurses.

Primary outcomes

Whole-body insulin sensitivity6 weeks

Change in insulin sensitivity from baseline, assessed using the hyperinsulinemic-euglycemic clamp (60 mU/m2/min)

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Victor Chang Cardiac Research Institute🇦🇺 Sydney, New South Wales, Australia

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Jennifer R Snaith, MD/PhDContact

Email · Call 61 2 9295 8600

Jennifer R Snaith, MD PHDPrincipal Investigator