Acute Metabolic Effects of Tirzepatide in Type 1 Diabetes
- Sponsor
- Victor Chang Cardiac Research Institute
- Study ID
- NCT06820281
- Phase
- PHASE2
- Status
- Not Yet Recruiting
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Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 65 Years
- Healthy Volunteers
- Not accepted
Interventions
- Tirzepatide 2.5mg weekly — DRUGTirzepatide 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) — DRUGPlacebo 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.
Study Details
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.
Key Dates
- Start date
- Jul 1, 2026
- Status verified
- May 2026
- Primary completion
- Dec 31, 2027
- Completion
- Dec 31, 2027
Study Design
- Enrollment
- 44 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Tirzepatide 2.5mg weeklyAdministered subcutaneously.
- Placebo Comparator: PlaceboAdministered subcutaneously.
Primary Outcome Measure
Whole-body insulin sensitivity [ Time Frame: 6 weeks ]
Central Contacts
- Jennifer R Snaith, MD PHD+61 2 9295 8600
- Jerry R Greenfield, MD PHD
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