Tirzepatide for metabolic effects in adults with type 1 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2, double-blind, placebo-controlled trial in 44 adults with type 1 diabetes. Participants will receive tirzepatide 2.5 mg or placebo weekly for 6 weeks and undergo detailed metabolic testing, including hyperinsulinemic-euglycemic and hypoglycemic clamps, to measure insulin sensitivity, hormone responses after meals and during hypoglycemia, and overnight metabolic changes. The study aims to see if tirzepatide can improve metabolic physiology in type 1 diabetes beyond weight loss effects, by examining prandial glucagon, lipolysis, and growth hormone dynamics. Data from this trial will extend prior findings from a similar study and help define mechanism-driven benefits of GLP-1/GIP co-agonism in T1D.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* age 18-70 years
* BMI ≥ 25 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; systemic steroids, antipsychotics, 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.
* Coronary event or stroke in last 6 months
* Active or untreated proliferative diabetic retinopathy
* Hemoglobin level \< 13.5 g/dL in men, \< 12.0 g/dL in women

Where it's running

• Victor Chang Cardiac Research Institute
  Sydney, New South Wales, Australia Recruiting

Study contacts

• Principal investigator: Jennifer R Snaith, MD PHD — Victor Chang Cardiac Research Institute
• Study coordinator: Jennifer R Snaith, MD PHD
• Email: j.snaith@victorchang.edu.au
• Phone: +61 2 9295 8600

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• VV-14300: a gene therapy approach for adults with type 1 diabetes not well controlled on an automated insulin system

  This trial tests VV-14300 in adults with type 1 diabetes who aren’t reaching their blood sugar goals despite using an automated insulin delivery system.

  Recruiting Phase 1/2 Kriya Therapeutics, Inc. · Toronto and 1 other locations · NCT07831798

• New gene therapies VV-14299 and VV-14300 for adults with Type 1 Diabetes failing automated insulin delivery

  This study tests VV-14299 and VV-14300, or VV-14300 alone, in adults with long-standing Type 1 Diabetes whose blood sugar remains poorly controlled despite using an automated insulin delivery system.

  Recruiting Phase 1/2 Kriya Therapeutics, Inc. · Melbourne · NCT07829302

• Oral verapamil in newly diagnosed children and teens with type 1 diabetes

  This study tests whether taking verapamil by mouth can help preserve pancreatic beta cells and reduce insulin needs in kids and teens with recently diagnosed type 1 diabetes.

  Recruiting Phase 2/3 Ain Shams University · Cairo · NCT07804849

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• Near-sensor insulin delivery with CGM in people with type 1 diabetes

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.