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Glucagon-like peptide-1 receptor agonist

Tirzepatide for Atherosclerosis in Type 2 Diabetes (T-PLAQUE Trial)

Phase 4
Recruiting
Led By Matthew A Budoff, MD
Research Sponsored by Matthew J. Budoff
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At the baseline visit, participants must be on a stable (>4 weeks) regiment of diabetes medications
Type 2 DM of minimum 5 years duration with HbA1c ≥7.0% to ≤10.5%
Must not have
Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years
Are currently planning treatment for diabetic retinopathy and/or macular edema
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial evaluates the effect of a new diabetes medicine on plaque buildup in the arteries of people with diabetes & atherosclerosis.

Who is the study for?
This trial is for adults aged 40-80 with type 2 diabetes and atherosclerosis, who have had the condition for at least 5 years, an HbA1c level of 7.0% to ≤10.5%, and are on stable diabetes medication. They must have two coronary artery plaques visible on CCTA and a BMI ≥25 kg/m². Exclusions include severe heart conditions, recent major cardiovascular events, certain cancers, renal insufficiency, planned surgeries affecting blood vessels or stomach, and allergies to CCTA contrast dye.
What is being tested?
The study tests Tirzepatide's effect on slowing down plaque buildup in arteries compared to a placebo in people with type 2 diabetes using advanced imaging (CCTA). Participants will be randomly assigned to either the drug or placebo group without knowing which one they receive (double-blind design) across multiple centers.
What are the potential side effects?
While not specified here, common side effects of drugs like Tirzepatide may include digestive issues such as nausea or diarrhea; potential low blood sugar levels; possible allergic reactions; injection site reactions; and rarely more serious problems like pancreatitis.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been on the same diabetes medication for more than 4 weeks.
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I have had type 2 diabetes for at least 5 years with an HbA1c between 7.0% and 10.5%.
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I am between 40 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been in remission for less than 5 years or have an untreated cancer.
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I am planning treatment for eye conditions related to diabetes.
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I have had pancreatitis before.
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I have had or am planning to have a procedure to improve blood flow to my heart or other parts of my body.
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I have not had a blood transfusion or severe blood loss in the last 3 months.
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I or my family have a history of MTC or MEN-2.
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I have type 1 diabetes.
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I am currently using GLP1-RA medication.
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I have had severe low blood sugar or didn't notice it happening in the last 6 months.
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My blood pressure is very high despite taking medication for it.
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I have had or am planning to have bypass surgery.
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My heart condition severely limits my daily activities.
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My kidney function is low, with an eGFR below 40 ml/min/1.73m2.
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I have had ketoacidosis or a severe hyperglycemic state.
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I have a known issue with my stomach emptying or have had/planning stomach surgery.
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I was hospitalized for a major heart problem in the last 2 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Reduction of total non-calcified coronary plaque volume
Secondary study objectives
Change in HgA1c lab values in the blood.
Reduction of low attenuation plaque volume
Reduction of total plaque volume, fibrous, lipid-rich and calcified plaque volumes using CCTA

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: TirzepatideActive Control1 Intervention
Tirzepatide 15mg Prefilled pen for weekly subcutaneous injection over 52 weeks
Group II: PlaceboPlacebo Group1 Intervention
Placebo Prefilled pen (volume matched) for weekly subcutaneous injection over 52 weeks

Find a Location

Who is running the clinical trial?

Matthew J. BudoffLead Sponsor
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterLead Sponsor
104 Previous Clinical Trials
46,463 Total Patients Enrolled
9 Trials studying Atherosclerosis
7,606 Patients Enrolled for Atherosclerosis
Eli Lilly and CompanyIndustry Sponsor
2,671 Previous Clinical Trials
3,228,924 Total Patients Enrolled
1 Trials studying Atherosclerosis
12,500 Patients Enrolled for Atherosclerosis

Media Library

Tirzepatide (Glucagon-like peptide-1 receptor agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05708859 — Phase 4
Atherosclerosis Research Study Groups: Tirzepatide, Placebo
Atherosclerosis Clinical Trial 2023: Tirzepatide Highlights & Side Effects. Trial Name: NCT05708859 — Phase 4
Tirzepatide (Glucagon-like peptide-1 receptor agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05708859 — Phase 4
~65 spots leftby Dec 2025
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