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TIRTLE2: Tirzepatide in Type 1 Diabetes

NCT06820281Phase 2

Key facts

Status: Recruiting
Start: Jul 2026
Primary completion: Dec 2027
Countries: 1
Sponsor: Victor Chang Cardiac Research Institute
Modality: Peptides, Recombinant Proteins and Enzymes

Drugs: tirzepatide
Conditions: type 1 diabetes mellitus (T1D)

Overview

Phase 2, randomised, double-blind trial in type 1 diabetes mellitus (T1D) comparing Tirzepatide 2.5mg weekly with Placebo (2 arms). Primary endpoint: Whole-body insulin sensitivity at 6 weeks. Started Jul 2026; status: recruiting.

Design

2 arms

Study design: RandomizedDouble-blind

Tirzepatide 2.5mg weekly
Administered subcutaneously.
Placebo
Administered subcutaneously.

Who it enrols

Adults aged 18-70 with Type 1 Diabetes for at least 2 years, BMI >= 25, HbA1c <= 9.0%, using an automated insulin delivery system, with no recent use of GLP-1 agonists, SGLT2 inhibitors, or metformin.

Endpoints

Primary

Whole-body insulin sensitivity6 weeks

Secondary

Prandial glucagon secretion6 weeks
Glucagon response to hypoglycemia6 weeks
Percentage of Time in level 2 hypoglycemia6 weeks
Percentage of Time in level 1 hypoglycemia6 weeks
Resting energy expenditure6 weeks
Overnight growth hormone curve6 weeks
Overnight free-fatty acids curve6 weeks
Total daily insulin dose6 weeks

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