A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight for the Maintenance of Weight Loss

What Was Tested

The trial (phase 3) is built around Tirzepatide for fat loss, obesity & body recomposition.

This was a study of tirzepatide in participants with obesity or overweight.

The main purpose was to learn more about how tirzepatide maintained body weight loss.

The study had two phases: a lead-in phase in which all participants took tirzepatide and a treatment phase in which participants either continued tirzepatide or switched to placebo.

It had three arms (groups): Tirzepatide (lead-in) (experimental), Tirzepatide MTD (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug and other.

Who Took Part

The registry lists 783 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.

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

Blinding on both sides kept the fat loss, obesity & body recomposition participants and researchers unaware of who received Tirzepatide.

Those kept unaware of assignments: participant and investigator.

It started in 2021-03-29 with completion listed for 2023-04-25.

It ran at 70 sites in United States (48), Brazil (8), Argentina (7), Taiwan (4) and Puerto Rico (3).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Percent Change From Randomization in Body Weight at Week 88 (time frame: Randomization (Week 36), Week 88).

It also tracked 25 secondary outcomes, for example Percent Change From Randomization in Body Weight at Week 64, Change From Randomization in Body Weight, Change From Randomization in Waist Circumference, Change From Randomization in Body Mass Index (BMI), Change From Randomization in Fasting Glucose and Change From Randomization in Hemoglobin A1c (HbA1c).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Tirzepatide in 783 people with fat loss, obesity & body recomposition.

With 783 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, Fat loss, obesity & body recomposition research.