A Study of Tirzepatide (LY3298176) on the Reduction on Morbidity and Mortality in Adults With Obesity

What Was Tested

The trial (phase 3) is built around Tirzepatide.

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

Participants will receive tirzepatide matched placebo.

The registry classes the interventions as drug.

Who Took Part

15374 actual participants took part.

It was open to people of any sex aged from 40 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) ≥27.0 kilogram/square meter (kg/m ²). Individuals ≥40 years of age with established cardiovascular disease (CVD). CVD is defined as meeting at least one of the following:. Coronary artery disease. Peripheral arterial disease OR.

The full record lists 10 inclusion and 13 exclusion criteria; among the exclusions: have type 1 diabetes (t1d) or (t2d), history of ketoacidosis, or hyperosmolar state/coma; any one of the following cv conditions within 90 days prior to screening; acute coronary syndrome.

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.

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 2022-10-11 with completion listed for 2027-10.

It ran at 671 sites in United States (165), Argentina (60), Mexico (41), China (32), Spain (29) and Brazil (28).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 18 secondary outcomes, for example Time to Onset of Type 2 Diabetes (T2D), Change from Baseline in Estimated Glomerular Filtration Rate (eGFR), Mean Change from Baseline Short Form-36 Version 2 (SF-36 v2) Acute Form Physical Functioning Domain Score, Time to First Occurrence of MI, Time to First Occurrence of Stroke and Time to First Occurrence of Coronary Revascularization.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Tirzepatide in 15374 people.

With 15374 participants it is a large trial for this field.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Tirzepatide compound page, all human trials.