Summary

Eligibility
for people ages 40-80 (full criteria)
Location
at UCLA
Dates
study started
completion around
Principal Investigator
by Matthew A Budoff, MD (ucla)

Description

Summary

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.

Details

This is a multi-center study in which 120 male and female participants who meet the eligibility criteria will be randomized. Study will assess changes in coronary atheroma volume comparing tirzepatide 15 mg/week plus Standard of Care (SOC), as compared to placebo plus SOC. Potential eligible participants may be prescreened for eligibility prior to the screening visit and must have a diagnosis of atherosclerosis (as assessed by >10% atheroma on CCTA) and T2DM.

Patients must be on a stable medical regiment (>4 weeks on statin therapy and diabetes medications) and undergo screening CCTA to demonstrate coronary plaque. 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. Participants will be asked to maintain stable doses of statins and diabetes medications. Persistent hyperglycemia will be treated by primary physician or endocrinologist,

Keywords

Type II Diabetes, Atherosclerosis, Coronary Artery Disease, Myocardial Ischemia, Type 2 Diabetes Mellitus, Tirzepatide

Eligibility

Location

  • Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center (The Lundquist Institute) accepting new patients
    Torrance California 90502 United States

Lead Scientist at University of California Health

  • Matthew A Budoff, MD (ucla)
    Professor-in-Residence, Medicine. Authored (or co-authored) 1463 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Matthew J. Budoff
ID
NCT05708859
Phase
Phase 4 research study
Study Type
Interventional
Participants
Expecting 120 study participants
Last Updated