Actively Recruiting
Effect of Tirzepatide on Progression of Coronary Atherosclerosis Using MDCT
Led by Matthew J. Budoff · Updated on 2024-10-15
120
Participants Needed
1
Research Sites
121 weeks
Total Duration
On this page
Sponsors
M
Matthew J. Budoff
Lead Sponsor
E
Eli Lilly and Company
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effect of Tirzepatide on Progression of Coronary Atherosclerosis Using MDCT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 40 to 80 years at consent
- Type 2 diabetes mellitus for at least 5 years with HbA1c between 7.0% and 10.5%
- Body mass index (BMI) of 25 kg/m2 or higher
- Presence of two discrete coronary artery plaques with more than 20% diameter narrowing on coronary CT angiography
- Stable diabetes medication regimen for more than 4 weeks at baseline
- Patients using oral hormonal contraceptives must switch to non-oral contraception or add a barrier method for 4 weeks after starting and after each dose increase
You will not qualify if you...
- Major cardiovascular event within the last 60 days
- Type 1 diabetes mellitus
- Current use of GLP1 receptor agonists
- Severe hypoglycemia or hypoglycemia unawareness in the past 6 months
- Planning treatment for diabetic retinopathy or macular edema
- History or planned coronary, carotid, or peripheral artery revascularization
- History of pancreatitis
- History of ketoacidosis or hyperosmolar state/coma
- Known significant gastric emptying problems or planned/previous gastric bypass or restrictive bariatric surgery
- Active or recent malignancy within 5 years
- Family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2
- Blood transfusion or severe blood loss within 90 days prior to screening or blood conditions affecting HbA1c
- Planned or prior bypass surgery
- Contraindication to coronary CT angiography or failed imaging quality
- Uncontrolled severe hypertension (systolic >180 mmHg or diastolic >100 mmHg) despite treatment
- New York Heart Association Class III or IV heart failure
- Renal insufficiency with eGFR less than 40 ml/min/1.73m2
- Hospitalization for major cardiovascular event including heart failure within past 2 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center (The Lundquist Institute)
Torrance, California, United States, 90502
Actively Recruiting
Research Team
S
Sajad Hamal, MS
CONTACT
F
Ferdinand Flores, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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