Tirzepatide Use in People With Obesity and Type 1 Diabetes

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age21+
SponsorDasman Diabetes Institute

About this trial

Tirzepatide, a gut hormone-based medication, has shown promising results in treating obesity, with \~22% weight loss and mild side effects. However, patients with type 2 diabetes typically experience only about 15% weight loss with tirzepatide, despite tolerating the medication well. Its effects in people with both obesity and type 1 diabetes remain largely unknown.

Although tirzepatide is not approved for glycemic control in type 1 diabetes, it is licensed for obesity treatment in Gulf and Europe. In Kuwait, more than a quarter of people with type 1 diabetes also have obesity, presenting a unique opportunity to study tirzepatide's impact.

This randomized, double-blind controlled trial will evaluate the safety and efficacy of tirzepatide in patients with type 1 diabetes and obesity, comparing usual care with the maximum tolerable dose of tirzepatide to assess its impact on weight loss. The findings may help address important safety concerns and have the potential to inform and influence future clinical practice.

Eligibility criteria

Qualifiers

Informed consent obtained before any trial-related activities.

Male or female, adults.

Documented diagnosis of T1DM (per ADA 2024definition/criteria) for at least 1 year before screening visit with C-peptide level of less than 0.01nm/L.

Body mass index (BMI) ≥ 27.0 kg/m2

Disqualifiers

Glycated hemoglobin (HbA1c) ≥86 mmol/mol (10%) as measured by the central laboratory at screening.

Treatment with a glucagon-like peptide-1 receptor agonist within 180 days before screening.

Preproliferative or proliferative retinopathy

Experienced diabetic ketoacidosis within 6 months of screening visit.

Trial design

Treatments tested in this trial

  • Tirzepatide
  • Placebo

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Dasman Diabetes Institute

Lead sponsor

University of Ulster

Collaborator