A Study of Tirzepatide (LY3298176) in Participants With Type 2 Diabetes Who Have Obesity or Are Overweight

What Was Tested

In this phase 3 trial, researchers set out to test Tirzepatide.

This is a study of tirzepatide in participants with type 2 diabetes who have obesity or are overweight.

The main purpose is to learn more about how tirzepatide affects body weight.

The study will last 79 weeks (22 visits).

Placebo administered SC QW.

The registry classes the interventions as drug and other.

Who Took Part

The registry lists 938 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 a BMI of ≥27 kg/m². Are overweight or have obesity. Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight. Are at least 18 years of age and age of majority per local laws and regulations.

The full record lists 5 inclusion and 10 exclusion criteria; among the exclusions: have type 1 diabetes mellitus, history of ketoacidosis or hyperosmolar state/coma or any other types of diabetes except t2dm; have proliferative diabetic retinopathy or diabetic macular edema or non-proliferative diabetic retinopathy that requires acute treatment; have self-reported change in body weight \>5kg within 3 months prior to screening.

How the Study Was Run

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

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.

Neither the participants nor the staff measuring them knew who was on Tirzepatide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2021-03-29 with completion listed for 2023-03-16.

It ran at 75 sites in United States (43), Argentina (8), Brazil (6), Taiwan (5), Japan (4) and Russia (4).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Percent Change From Baseline in Body Weight (time frame: Baseline, Week 72).

It also tracked 24 secondary outcomes, for example Change From Baseline in Absolute Body Weight, Change From Baseline in Body Mass Index (BMI), Change From Baseline in Hemoglobin A1c (HbA1c), Change From Baseline in Fasting Glucose, Change From Baseline in Waist Circumference and Percent Change From Baseline in Fasting Insulin.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Tirzepatide in 938 people.

With 938 participants it is a large trial for this field.

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.