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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 Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
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%
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
T-PLAQUE 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.Check my eligibility
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.See study design
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.
T-PLAQUE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
T-PLAQUE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Reduction of total non-calcified coronary plaque volume
Secondary outcome measures
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
T-PLAQUE 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
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Who is running the clinical trial?
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterLead Sponsor
101 Previous Clinical Trials
46,181 Total Patients Enrolled
9 Trials studying Atherosclerosis
7,606 Patients Enrolled for Atherosclerosis
Eli Lilly and CompanyIndustry Sponsor
2,618 Previous Clinical Trials
3,201,440 Total Patients Enrolled
1 Trials studying Atherosclerosis
12,500 Patients Enrolled for Atherosclerosis
Matthew A Budoff, MDPrincipal InvestigatorThe Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
1 Previous Clinical Trials
100 Total Patients Enrolled
1 Trials studying Atherosclerosis
100 Patients Enrolled for Atherosclerosis
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been on the same diabetes medication for more than 4 weeks.Your body mass index (BMI) is 25 or higher.I have been in remission for less than 5 years or have an untreated cancer.I am planning treatment for eye conditions related to diabetes.I have had pancreatitis before.I use non-oral or additional barrier contraception during my treatment.I have had type 2 diabetes for at least 5 years with an HbA1c between 7.0% and 10.5%.I have had or am planning to have a procedure to improve blood flow to my heart or other parts of my body.I have not had a blood transfusion or severe blood loss in the last 3 months.You had a serious allergic reaction to the contrast dye used in a previous heart imaging test, or your heart imaging test did not meet the required standards after two attempts.I or my family have a history of MTC or MEN-2.I have type 1 diabetes.I am currently using GLP1-RA medication.I have had severe low blood sugar or didn't notice it happening in the last 6 months.I have had a major heart event in the last 2 months.I am between 40 and 80 years old.My blood pressure is very high despite taking medication for it.I have had or am planning to have bypass surgery.My heart condition severely limits my daily activities.You have two blocked arteries in your heart.My kidney function is low, with an eGFR below 40 ml/min/1.73m2.I have had ketoacidosis or a severe hyperglycemic state.I have a known issue with my stomach emptying or have had/planning stomach surgery.I was hospitalized for a major heart problem in the last 2 months.
Research Study Groups:
This trial has the following groups:- Group 1: Tirzepatide
- Group 2: Placebo
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are younger participants eligible to be enrolled in this experiment?
"This study is accepting patients that are between 40 and 80 years old."
Answered by AI
What potential hazards could be associated with Tirzepatide usage?
"Based on the Phase 4 status, which denotes approval of Tirzepatide for medical use, our team at Power assigned it a safety score of 3."
Answered by AI
Are there opportunities for participants to join this research study?
"Per the information presented on clinicaltrials.gov, this trial is not actively recruiting patients; however, it was originally posted in February of 2023 and last updated at the end of January in that same year. Despite its current state, there are 1405 other trials which are currently searching for candidates."
Answered by AI
Is it possible to partake in this medical experiment?
"This trial is currently recruiting 120 people aged 40-80 with diabetes type 2. To qualify, participants must be on a stable medication course for greater than 4 weeks prior to the baseline visit and have an HbA1c of 7%-10.5%, BMI ≥25kg/m2, as well as two visible coronary artery plaques with >20% diameter stenosis confirmed by CCTA scans. Furthermore, if using oral contraceptives it is necessary to switch or add additional barrier methods of contraception for four weeks after initiation and each dose increase."
Answered by AI
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