Acute Metabolic Effects of Tirzepatide in Type 1 Diabetes

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorVictor Chang Cardiac Research Institute

About this trial

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 criteria

Qualifiers

age 18-65 years

BMI ≥ 27 kg/m2

HbA1c ≤ 9.0%

insulin delivery using an automated insulin delivery system

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Tirzepatide 2.5mg weekly
  • Placebo injection (normal saline)

Treatment groups

44 Participants
are divided into 2 treatment groups

Locations

1
Victor Chang Cardiac Research Institute2010, SydneyNew South Wales, Australia

Sponsors and collaborators

Victor Chang Cardiac Research Institute

Lead sponsor