Tirzepatide for the Treatment of Concurrent Type 1 Diabetes and Overweight or Obesity

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorRoyal North Shore Hospital

About this trial

This study is a 2-arm, double blinded, randomised clinical trial where 40 participants will be assigned 1:1 to insulin treatment alone (control) or insulin treatment and tirzepatide treatment for 32 weeks. The primary objective is to demonstrate that tirzepatide treatment, dose incremented to 15mg QW for 32 weeks adjunctive to insulin treatment can reduce body weight in patients with T1D and overweight or obesity when compared to insulin treatment alone. The secondary objective is to demonstrate that tirzepatide treatment, dose incremented to 15mg QW for 32 weeks can improve glycaemic control (measured by hbA1c), improve time in range, reduce insulin requirements, and reduce the severity of comorbidities in people with obesity and T1D. This trial includes a 6 month follow-up period.

Eligibility criteria

Qualifiers

Age 18-70 years at screening

A clinical diagnosis of T1D for at least 12 months at time of screening

Body mass index ≥ 27kg/m2

HbA1c ≤ 10%

Disqualifiers

Age <18 years and >70 years

A clinical diagnosis of diabetes type other than T1D

HbA1c > 10%

Use of GLP-1 receptor agonist within 1 month of study screening

Trial design

Treatments tested in this trial

  • Tirzepatide

Treatment groups

40 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators