Acute Metabolic Effects of Tirzepatide in Type 1 Diabetes

NCT06820281 · Not yet recruiting

Last updated 2026-05-28

This clinical trial tests how tirzepatide affects insulin sensitivity in adults with type 1 diabetes.

Status Not yet recruiting Approved but enrollment has not started.

Phase Phase 2 Tests whether it works and watches safety in a moderate group.

Type Interventional (clinical trial)

Design Randomized, quadruple-blind treatment study

Participants 44 people Planned (estimated).

Who can join Ages 18–65 · all sexes

Timeline Started 2026-07 · est. completion 2027-12

Where 1 site · Australia

What this study is testing ClinicalTrials.gov NCT06820281 ↗

Description as written by the study sponsor.

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.

Treatments tested

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.

Main thing measured	Whole-body insulin sensitivity
Sponsor	Victor Chang Cardiac Research Institute
Conditions studied	Type 1 Diabetes Mellitus
GLP-1 drugs	tirzepatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT06820281 ↗