Tirzepatide for the treatment of adults living with concurrent type 1 diabetes and overweight or obesity (TZP-T1D): a double-blind, placebo-matched randomised controlled trial protocol

Sep 17, 2025BMJ open

Tirzepatide for treating adults with type 1 diabetes who are overweight or obese: a double-blind, placebo-controlled trial plan

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Abstract

A total of 60 participants with type 1 diabetes and overweight/obesity will be evaluated for changes in body weight after 32 weeks of tirzepatide treatment.

Participants will be aged 18-70 years, with a body mass index of 27 kg/m² or higher and HbA1c levels of 10% or lower.
The primary outcome is the percentage change in body weight, with secondary outcomes including changes in HbA1c and various thresholds of body weight loss.
Adverse events, compliance, and medication interactions will be monitored closely throughout the trial.
Patient-reported outcomes will assess the benefits of glycaemic management, weight management, and overall quality of life.

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INTRODUCTION: The increasing prevalence of overweight and obesity among individuals with type 1 diabetes (T1D) complicates glycaemic management and escalates insulin resistance, necessitating innovative therapeutic strategies. Tirzepatide, a dual agonist for glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide receptors, shows promise in managing weight and glycaemic control in type 2 diabetes but is unexplored in the context of T1D. This double-blind, placebo-controlled randomised trial will evaluate the efficacy of tirzepatide in adults with T1D and overweight/obesity over 32 weeks.

METHODS AND ANALYSIS: 60 participants (aged 18-70 years) with a body mass index ≥27 kg/mand HbA1c≤10% will be randomised 1:1 to receive either tirzepatide or a placebo, alongside standard insulin therapy. The primary outcome is the change in body weight (%). Secondary measures include change in HbA1c (%), proportion of body weight lost (>5%, >10%, >15% and >20%), changes in insulin dosage, time in range by continuous glucose monitoring (CGM) criteria and severity of comorbidities. Compliance, adverse events and medication interactions will be closely monitored, with adjustments made for tolerability. Patient-reported outcomes and experiences will be measured to capture the benefits of glycaemic management, weight management and quality of life. To compare the means of body weight reduction (%) between the tirzepatide and control groups, an independent samples t-test will be employed under the assumption that data are normally distributed. Secondary outcome measures will be analysed by Student's t-test. All data will be reported as group means with confidence intervals, with default statistical significance assumed at p<0.05. 2

ETHICS AND DISSEMINATION: Ethical approval has been obtained from the Northern Sydney Local Health District's Human Research Ethics Committee (approval ID #2024/ETH00180).

TRIAL REGISTRATION NUMBER: NCT06180616.

Key numbers

Participants Enrolled

Total participants randomized for the trial.

32 weeks

Trial Duration

Duration of the intervention period.

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Tirzepatide for the treatment of adults living with concurrent type 1 diabetes and overweight or obesity (TZP-T1D): a double-blind, placebo-matched randomised controlled trial protocol

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