| Trial ID: | L5375 |
| Source ID: | NCT05708859
|
| Associated Drug: |
Tirzepatide
|
| Title: |
Effect of Tirzepatide on Progression of Coronary Atherosclerosis Using MDCT
|
| Acronym: |
T-PLAQUE
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type II Diabetes|Atherosclerosis
|
| Interventions: |
DRUG: Tirzepatide|DRUG: Placebo
|
| Outcome Measures: |
Primary: Reduction of total non-calcified coronary plaque volume, Reduction of total non-calcified coronary plaque volume from baseline (start of the study) till the final visit will be measured using Coronary Computed Tomography Angiography (CCTA)., 12 months | Secondary: Reduction of low attenuation plaque volume, Reduction change in low attenuation plaque volume from baseline (start of the study) till the final visit will be measured using Coronary Computed Tomography Angiography (CCTA), 12 months|Reduction of total plaque volume, fibrous, lipid-rich and calcified plaque volumes using CCTA, Reduction change of total plaque volume, fibrous, lipid-rich and calcified plaque volumes will be compared between baseline and at the end of the study., 12 months|Change in HgA1c lab values in the blood., Change in HgA1c lab values in the blood will be compared between baseline and at the end of the study., 12 months
|
| Sponsor/Collaborators: |
Sponsor: Matthew J. Budoff | Collaborators: Eli Lilly and Company
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
120
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: HEALTH_SERVICES_RESEARCH
|
| Start Date: |
2024-01-02
|
| Completion Date: |
2026-05
|
| Results First Posted: |
|
| Last Update Posted: |
2024-10-15
|
| Locations: |
Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center (The Lundquist Institute), Torrance, California, 90502, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT05708859
|
