NCT06180616

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

Tirzepatide for the Treatment of Concurrent Type 1 Diabetes and Overweight or Obesity: A Placebo-Matched Randomised Controlled Trial

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Royal North Shore Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Type 1 Diabetes Mellitus
• Overweight and Obesity

Interventions

Type	Name	Description
DRUG	Tirzepatide	Tirzepatide will be self-administered subcutaneously by study participants via an injection. The drug will be taken weekly following the schedule: 4 weeks at 2.5 mg QW, 4 weeks at 5.0 mg QW, 4 weeks at 7.5 mg QW, 4 weeks at 10.0 mg QW, 4 weeks at 12.5 mg QW, 12 weeks at 15 mg QW. Modification of study drug will be performed if the participant is experiencing significant side effects and cannot tolerate the higher dosage of the study drug. In this instance, the study drug dosage will be reduced to the previously tolerated dosage and held at this dose for a further 4 weeks. One further attempt at dose escalation will be undertaken after 4 weeks, at the discretion of the participant and the study investigator. If recurrent side effects are experienced by the participant, the study drug will be returned to the previously tolerated dosage, and the prescription continued at this dosage for the remainder of the study.

Timeline

• Start date: 2026-12-01
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2023-12-22
• Last updated: 2025-07-29

Regulatory

• FDA-regulated drug study