Tirzepatide for Atherosclerosis in Type 2 Diabetes

(T-PLAQUE Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Matthew A Budoff, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Matthew J. Budoff

Must be taking: Diabetes medications

Must not be taking: GLP1-RA

Disqualifiers: Type 1 diabetes, Severe hypoglycemia, Pancreatitis, others

Prior Safety Data

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but you must be on a stable diabetes medication regimen for more than 4 weeks before starting the trial.

What data supports the effectiveness of the drug Tirzepatide for atherosclerosis in type 2 diabetes?

Tirzepatide, a drug approved for type 2 diabetes, has shown benefits like lowering blood sugar and weight loss, which are important for heart health. Although specific data on atherosclerosis is not available, its positive effects on cardiovascular risk factors suggest it might help with atherosclerosis in type 2 diabetes. ^{1 2 3 4 5}

Is tirzepatide safe for humans?

Tirzepatide has been studied in people with type 2 diabetes and has shown a safety profile similar to other treatments in its class, with no increased risk of major cardiovascular events. It has been approved for use in several countries, indicating it is generally considered safe for humans. ^{1 2 4 6 7}

How is the drug Tirzepatide unique for treating atherosclerosis in type 2 diabetes?

Tirzepatide is unique because it combines the effects of two hormones, GIP and GLP-1, to help control blood sugar and improve heart health. This dual action, known as 'twincretin', not only helps with diabetes management but also shows potential cardiovascular benefits, which could be beneficial for atherosclerosis. ^{2 4 8 9 10}

Research Team

Matthew A Budoff, MD

Principal Investigator

The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Eligibility Criteria

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.

Inclusion Criteria

I have been on the same diabetes medication for more than 4 weeks.

Your body mass index (BMI) is 25 or higher.

I use non-oral or additional barrier contraception during my treatment.

Exclusion Criteria

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.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive tirzepatide or placebo for 52 weeks with weekly subcutaneous injections

52 weeks

Weekly visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

Treatment Details

Interventions

• Placebo (Drug)
• Tirzepatide (Glucagon-like peptide-1 receptor agonist)

Trial Overview 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.

Participant Groups

Group I: Tirzepatide Active Control 1 Intervention

Tirzepatide 15mg Prefilled pen for weekly subcutaneous injection over 52 weeks

Group II: Placebo Placebo Group 1 Intervention

Placebo Prefilled pen (volume matched) for weekly subcutaneous injection over 52 weeks

Tirzepatide is already approved in Canada for the following indications:

Approved in Canada as Mounjaro for:

• Type 2 diabetes

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center (The Lundquist Institute) Torrance, CA

Who Is Running the Clinical Trial?

Matthew J. Budoff

Lead Sponsor

Trials

1

Patients Recruited

120+

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Lead Sponsor

Trials

105

Patients Recruited

46,600+

Eli Lilly and Company

Industry Sponsor

Trials

2708

Patients Recruited

3,720,000+

Findings from Research

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tirzepatide versus insulin glargine in type 2 diabetes and increased cardiovascular risk (SURPASS-4): a randomised, open-label, parallel-group, multicentre, phase 3 trial. Del Prato, S., Kahn, SE., Pavo, I., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Challenging Clinical Perspectives in Type 2 Diabetes with Tirzepatide, a First-in-Class Twincretin. MacIsaac, RJ., Deed, G., D'Emden, M., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Profile of tirzepatide in the management of type 2 diabetes mellitus: design, development, and place in therapy. Naseralallah, L., Aboujabal, B.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of type 2 diabetes with the dual GIP/GLP-1 receptor agonist tirzepatide: a systematic review and meta-analysis. Karagiannis, T., Avgerinos, I., Liakos, A., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel Dual Incretin Agent, Tirzepatide (LY3298176), for the Treatment of Type 2 Diabetes Mellitus and Cardiometabolic Health. Bucheit, J., Ayers, J., Pamulapati, L., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of tirzepatide and dulaglutide on major adverse cardiovascular events in participants with type 2 diabetes and atherosclerotic cardiovascular disease: SURPASS-CVOT design and baseline characteristics. Nicholls, SJ., Bhatt, DL., Buse, JB., et al.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tirzepatide cardiovascular event risk assessment: a pre-specified meta-analysis. Sattar, N., McGuire, DK., Pavo, I., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tirzepatide: A Systematic Update. Forzano, I., Varzideh, F., Avvisato, R., et al.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Cardiovascular Effect of Tirzepatide: A Glucagon-Like Peptide-1 and Glucose-Dependent Insulinotropic Polypeptide Dual Agonist. Cho, YK., La Lee, Y., Jung, CH.[2023]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tirzepatide - a dual GIP/GLP-1 receptor agonist - a new antidiabetic drug with potential metabolic activity in the treatment of type 2 diabetes. Nowak, M., Nowak, W., Grzeszczak, W.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Tirzepatide versus insulin glargine in type 2 diabetes and increased cardiovascular risk (SURPASS-4): a randomised, open-label, parallel-group, multicentre, phase 3 trial. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Challenging Clinical Perspectives in Type 2 Diabetes with Tirzepatide, a First-in-Class Twincretin. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Profile of tirzepatide in the management of type 2 diabetes mellitus: design, development, and place in therapy. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

Management of type 2 diabetes with the dual GIP/GLP-1 receptor agonist tirzepatide: a systematic review and meta-analysis. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

A Novel Dual Incretin Agent, Tirzepatide (LY3298176), for the Treatment of Type 2 Diabetes Mellitus and Cardiometabolic Health. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Comparison of tirzepatide and dulaglutide on major adverse cardiovascular events in participants with type 2 diabetes and atherosclerotic cardiovascular disease: SURPASS-CVOT design and baseline characteristics. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Tirzepatide cardiovascular event risk assessment: a pre-specified meta-analysis. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Tirzepatide: A Systematic Update. [2022]

9. Korea (South) pubmed.ncbi.nlm.nih.gov

The Cardiovascular Effect of Tirzepatide: A Glucagon-Like Peptide-1 and Glucose-Dependent Insulinotropic Polypeptide Dual Agonist. [2023]

10. Poland pubmed.ncbi.nlm.nih.gov

Tirzepatide - a dual GIP/GLP-1 receptor agonist - a new antidiabetic drug with potential metabolic activity in the treatment of type 2 diabetes. [2022]