A Study of Tirzepatide (LY3298176) In Participants After A Lifestyle Weight Loss Program

What Was Tested

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

This is a study of tirzepatide in participants with obesity.

The purpose of this study is to learn more about how tirzepatide maintains body weight or adds to weight loss after an intensive lifestyle modification program.

The study will last about 2 years (29 visits).

It had two arms (groups): Tirzepatide (experimental) and Placebo (placebo comparator).

Participants received matching placebo SC once weekly (QW).

The registry classes the interventions as drug and other.

Who Took Part

The registry lists 579 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 body mass index (BMI) ≥30 kg/m2 or ≥27 kg/m2 and previously diagnosed with at least 1 of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease. 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

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

The fat loss, obesity & body recomposition participants were allocated by chance, so the Tirzepatide group and the comparison group should start out alike.

Groups ran in parallel: each of the fat loss, obesity & body recomposition participants stayed in one arm throughout.

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 2023-04-20.

It ran at 65 sites in United States (45), Argentina (9), Brazil (8) and Puerto Rico (3).

Its stated primary purpose is treatment.

What Was Measured

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

It also tracked 20 secondary outcomes, for example Change From Baseline in Waist Circumference, Change From Baseline in Body Weight, Change From Baseline in Body Mass Index (BMI), Change From Baseline in Systolic Blood Pressure (SBP), Change From Baseline in Diastolic Blood Pressure (DBP) and Percent Change From Baseline in Total Cholesterol.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Tirzepatide in 579 people with fat loss, obesity & body recomposition.

With 579 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.