A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Not Controlled With Diet and Exercise Alone

What Was Tested

The trial (phase 3) is built around Tirzepatide.

The study will last approximately 47 weeks and may include about 15 visits.

It had four arms (groups): one (experimental), one (experimental), one (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 478 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Have been diagnosed with type 2 diabetes mellitus (T2DM). Are naïve to diabetes injectable therapies and have not used any oral antihyperglycemic medications (OAMs) during the 3 months preceding screening. Have a BMI ≥23 kilograms per meter squared (kg/m²) at screening.

The full record lists 5 inclusion and 8 exclusion criteria; among the exclusions: have type 1 diabetes mellitus; have had chronic or acute pancreatitis any time prior to study entry; have proliferative diabetic retinopathy or diabetic maculopathy or nonproliferative diabetic retinopathy requiring acute treatment.

How the Study Was Run

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

The participants were allocated by chance, so the Tirzepatide group and the comparison group should start out alike.

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

As a double-blind Tirzepatide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2019-06-03 with completion listed for 2020-10-05.

It ran at 53 sites in United States (28), Japan (10), India (9), Mexico (4) and Puerto Rico (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change From Baseline in Hemoglobin A1c (HbA1c) (time frame: Baseline, Week 40).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Tirzepatide in 478 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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