A Study of Tirzepatide (LY3298176) in Participants With Obesity Disease

What Was Tested

This registered phase 3 trial tested Tirzepatide.

The main purpose of this study is to learn more about tirzepatide in participants with obesity disease.

The study will last around 72 Weeks.

Participants received matching placebo administered SC QW.

The registry classes the interventions as drug and other.

Who Took Part

267 actual participants took part.

It was open to people of any sex aged from 20 years with no upper age limit.

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

Examples of who could join: Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.

The full record lists 2 inclusion and 12 exclusion criteria; among the exclusions: have diabetes; acute or chronic liver disease other than nafld; have a self-reported change in body weight \>5 kg within 3 months prior to screening.

How the Study Was Run

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

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.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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

Those kept unaware of assignments: participant and investigator.

It started in 2021-05-10 with completion listed for 2023-06-24.

It ran at 18 sites in Japan (18).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Mean Percent Change in Body Weight (time frame: Baseline, 72 Weeks).

It also tracked 24 secondary outcomes, for example Change From Baseline in Fasting Glucose for Participants With IGT at Baseline, Change From Baseline in Oral Glucose Tolerance (OGTT) 2-hr Glucose for Participants With Impaired Glucose Tolerance (IGT) at Baseline, Percent Change From Baseline in Fasting Lipids [Triglycerides (TG)] for Participants With Hyperlipidemia at Baseline, Percent Change From Baseline in Hepatic Fat Fraction (HFF) for Participants With Non-alcoholic Fatty Liver Disease [NAFLD], Change From Baseline in Absolute Body Weight and Change From Baseline in Body Mass Index (BMI).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Tirzepatide in 267 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.