A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight

What Was Tested

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

This is a study of tirzepatide in participants with overweight and obesity.

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

The study has two phases: A main phase and an extension phase.

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 2539 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: History of at least one unsuccessful dietary effort to lose body weight.

The full record lists 2 inclusion and 7 exclusion criteria; among the exclusions: diabetes mellitus; change in body weight greater than 5 kg within 3 months prior to starting study; obesity induced by other endocrinologic disorders or monogenetic or syndromic forms of obesity.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

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

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

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 2019-12-04 with completion listed for 2022-04-01.

It ran at 118 sites in United States (54), Mexico (10), Argentina (9), Russia (9), Brazil (8) and China (7).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percent Change From Baseline in Body Weight (Primary Treatment Period) (time frame: Baseline, Week 72).

It also tracked 24 secondary outcomes, for example Change From Baseline in Waist Circumference (Primary Treatment Period), Percent Change From Baseline in Body Weight (Primary and Additional Treatment Periods : Participants With Prediabetes at Randomization), Change From Baseline in Body Mass Index (BMI) - Primary Treatment Period, Change From Baseline in Hemoglobin A1c (HbA1c) - Primary Treatment Period and Change From Baseline in Fasting Glucose (Primary Treatment Period).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Tirzepatide in 2539 people.

With 2539 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.