Trial intelligence / Profile preview

Tirzepatide for T1D and Obesity

NCT06180616Phase 2

Key facts

Status: Not yet recruiting
Start: Dec 2026
Primary completion: Dec 2028
Sponsor: Royal North Shore Hospital
Modality: Peptides, Recombinant Proteins and Enzymes

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

Overview

Phase 2, randomised, double-blind trial of tirzepatide in type 1 diabetes mellitus (T1D), Overweight and obesity (2 arms), sponsored by Royal North Shore Hospital. Primary endpoint: Body weight at 32 weeks. Planned start Dec 2026; status: not yet recruiting.

Design

2 arms

Study design: RandomizedDouble-blind

Tirzepatide Treatment
Tirzepatide (escalated to 15mg QW) + Insulin
Insulin Treatment
Placebo + Insulin

Who it enrols

Adults with Type 1 Diabetes for at least 12 months, BMI >= 27 kg/m2, and HbA1c <= 10%, on insulin therapy.

Endpoints

Primary

Body weight32 weeks

Secondary

Hemoglobin A1c32 weeks
Time in Range32 weeks
Total daily insulin dose32 weeks
Insulin carbohydrate ratio32 weeks
Waist and neck circumference32 weeks
Blood pressure32 weeks
Mean glucose32 weeks
Time in hypoglycaemia32 weeks

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