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 groupsSponsors 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