Effect of Tirzepatide on Progression of Coronary Atherosclerosis Using MDCT

What Was Tested

In this phase 4 trial, researchers set out to test Tirzepatide.

A multi-center, randomized, double-blind, placebo-controlled, parallel-group phase IV Study evaluating the effects of tirzepatide on atherosclerotic plaque progression assessed by coronary computed tomography angiography (CCTA) in participants with a diagnosis of type II Diabetes (T2DM) and atherosclerosis.

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

Placebo Prefilled pen (volume matched) for weekly subcutaneous injection over 52 weeks.

The registry classes the interventions as drug.

More on the Plan

This is a multi-center study in which 120 male and female participants who meet the eligibility criteria will be randomized.

Participant eligibility will be assessed by the Imaging Core Lab.

If the participant meets all entry criteria during baseline visit, then consenting participants will be randomized 1:1 to receive tirzepatide on top of standard of care for treatment period of 12 months.

Persistent hyperglycemia will be treated by primary physician or endocrinologist,.

Who Took Part

Enrollment: 120 planned participants were the target.

It was open to people of any sex aged from 40 years up to 80 years.

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

Examples of who could join: Male or female 40 years to 80 years of age at signing of informed consent. Body mass index (BMI) ≥25 kilograms per meter squared (kg/m²). At the baseline visit, participants must be on a stable (\>4 weeks) regiment of diabetes medications.

The full record lists 6 inclusion and 18 exclusion criteria; among the exclusions: have had a major cardiovascular event within the last 60 days; have type 1 diabetes mellitus; current use of glp1-ra.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-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.

Blinding on both sides kept the participants and researchers unaware of who received Tirzepatide.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2024-01-02 with completion listed for 2025-12.

It ran at 1 site in United States.

Its stated primary purpose is health services research.

What Was Measured

It also tracked 3 secondary outcomes, for example Change in HgA1c lab values in the blood.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Tirzepatide in 120 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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