The Effect of Retatrutide Once Weekly on Cardiovascular Outcomes and Kidney Outcomes in Adults Living With Obesity (TRIUMPH-Outcomes)

What Was Tested

This registered phase 3 trial tested Retatrutide for atherosclerosis, cardiovascular disease & high blood pressure.

The trial will enroll adults with body mass index 27 kg/m\^2 or higher and Atherosclerotic Cardiovascular Disease and/or chronic kidney disease.

The study will last for about 5 years.

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

Participants will receive matching placebo administered SC.

The registry classes the interventions as drug.

Who Took Part

The registry lists 10000 planned participants were the target.

It was open to people of any sex aged from 45 years with no upper age limit.

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

Examples of who could join: Participants have established atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD), as evidenced at least one of the following:. Coronary artery disease. Peripheral arterial disease. Chronic kidney disease defined as:. A Body Mass Index of ≥27.0 kilograms per meter squared (kg/m\^2).

The full record lists 10 inclusion and 16 exclusion criteria; among the exclusions: participants have type 1 diabetes or any history of diabetic ketoacidosis; participants have any of the following cardiovascular conditions ≤ 90 days prior to randomization:; myocardial infarction.

How the Study Was Run

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

Because people in this Retatrutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Neither the atherosclerosis, cardiovascular disease & high blood pressure participants nor the staff measuring them knew who was on Retatrutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2024-04-30 with completion listed for 2029-02.

It ran at 742 sites in United States (204), Argentina (59), Brazil (48), Mexico (40), Czechia (32) and Netherlands (28).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Time to First Occurrence of Composite Endpoints (time frame: Randomization up to Study Completion (Approximate 248 Weeks)).

It also tracked 5 secondary outcomes, for example Time to First Occurrence of Composite Endpoint of Major Cardiovascular Events (MACE-3).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Retatrutide in 10000 people with atherosclerosis, cardiovascular disease & high blood pressure.

With 10000 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 Retatrutide compound page, Atherosclerosis, cardiovascular disease & high blood pressure research.