Tirzepatide Use in People With Obesity and Type 1 Diabetes

What Was Tested

This registered phase 4 trial tested Tirzepatide.

It had two arms (groups): Tirzepatide (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

60 planned participants were the target.

It was open to people of any sex aged from 21 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Informed consent obtained before any trial-related activities. Male or female, adults. Documented diagnosis of T1DM (per ADA 2024definition/criteria) for at least 1 year before screening visit with C-peptide level of less than 0.01nm/L. Body mass index (BMI) ≥ 27.0 kg/m2. History of at least one self-reported unsuccessful dietary effort to lose body weight.

The full record lists 6 inclusion and 36 exclusion criteria; among the exclusions: treatment with a glucagon-like peptide-1 receptor agonist within 180 days before screening; preproliferative or proliferative retinopathy; experienced diabetic ketoacidosis within 6 months of screening visit.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Because people in this Tirzepatide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Tirzepatide group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Tirzepatide.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2025-07-31 with completion listed for 2028-02-25.

It ran at 1 site in Kuwait.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Bodyweight (time frame: 76 weeks).

It also tracked 11 secondary outcomes, for example HbA1c, Time in range, Systolic Blood pressure, Diastolic Blood pressure, Time in hypoglycaemia and Total cholesterol.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Tirzepatide in 60 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Tirzepatide compound page, all human trials.