Effect of Tirzepatide on Progression of Coronary Atherosclerosis Using MDCT
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age40-80
SponsorMatthew J. Budoff
About this trial
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.
Eligibility criteria
Qualifiers
Male or female 40 years to 80 years of age at signing of informed consent
Type 2 DM of minimum 5 years duration with HbA1c ≥7.0% to ≤10.5%
Body mass index (BMI) ≥25 kilograms per meter squared (kg/m²)
Presence of two discrete coronary artery plaques with visual diameter stenosis >20% on CCTA
Disqualifiers
Have had a major cardiovascular event within the last 60 days
Have type 1 diabetes mellitus
Current use of GLP1-RA
Have a history of severe hypoglycemia and/or hypoglycemia unawareness within the last 6 months
Trial design
Treatments tested in this trial
- Tirzepatide
- Placebo
Treatment groups
120 Participants
are divided into 2 treatment groupsLocations
1Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center (The Lundquist Institute)90502, TorranceCalifornia, United States
Sponsors and collaborators
Matthew J. Budoff
Lead sponsor
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Sponsor institution
Eli Lilly and Company
Collaborator
Source ClinicalTrials.gov