Health TrialsbyHealthPanel

Effect of Tirzepatide on Progression of Coronary Atherosclerosis Using MDCT

ConditionsType II DiabetesAtherosclerosis
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Tirzepatide

    Drug

    Tirzepatide 15mg Subcutaneous Solution

  • Placebo

    Drug

    Volume matched Subcutaneous Solution

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: TirzepatideActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
12 months

Secondary outcomes

1

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)

Time frame
12 months
2

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.

Time frame
12 months
3

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.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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
Apply now