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

What Was Tested

This registered phase 2 trial tested Tirzepatide.

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.

It had two arms (groups): Insulin Treatment (no intervention) and Tirzepatide Treatment (experimental).

Participants will remain on their typical insulin therapy regime for 32 weeks.

The registry classes the interventions as drug.

Who Took Part

The registry lists 40 planned participants were the target.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Age 18-70 years at screening. A clinical diagnosis of T1D for at least 12 months at time of screening. Body mass index ≥ 27kg/m2. Capable and willing to self-inject tirzepatide once per week. Able and willing to provide written informed consent for study participation.

The full record lists 12 inclusion and 32 exclusion criteria; among the exclusions: age \<18 years and \>70 years; A clinical diagnosis of diabetes type other than T1D; use of glp-1 receptor agonist within 1 month of study screening.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

Random assignment meant chance, not the researchers, decided who got Tirzepatide and who got the comparison, which limits bias.

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 2026-12 with completion listed for 2028-12.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Body weight (time frame: 32 weeks).

It also tracked 26 secondary outcomes, for example hbA1c, Time in range, Insulin carbohydrate ratio, Waist and neck circumference, Blood pressure and Mean glucose.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Tirzepatide in 40 people.

Its status is not yet recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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