Type II DiabetesPhase 4T-PLAQUENCT05708859
Effect of Tirzepatide on Progression of Coronary Atherosclerosis Using MDCT
A Phase 4 study testing Tirzepatide in people with Type II Diabetes and Atherosclerosis, run by Matthew J. Budoff at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Type II Diabetes, Atherosclerosis
- What is being tested?
- Tirzepatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2024to May 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- At the baseline visit, participants must be on a stable (>4 weeks) regiment of diabetes medications.
- Patients using oral hormonal contraceptives must switch to a non-oral contraceptive method, or add a barrier method of contraception for 4 weeks after initiation and for 4 weeks after each dose escalation
Who cannot join
- 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
- Are currently planning treatment for diabetic retinopathy and/or macular edema
- Have history of, or currently planning a coronary, carotid, or peripheral artery revascularization (ie - stent, bypass)
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- Have a history of pancreatitis
- Have a history of ketoacidosis or hyperosmolar state/coma
- Have a known clinically significant gastric emptying abnormality, have undergone or currently planning any gastric outlet obstruction, or have undergone or currently planning any gastric bypass (bariatric) surgery or restrictive bariatric surgery
- Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years
- Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
- Have had a blood transfusion or severe blood loss within 90 days prior to screening or have known hematological conditions that may interfere with HbA1c measurement
- Planned or Prior Bypass surgery
- Contradiction for CCTA (e.g. serious allergic reaction to the contrast dye) or CCTA not meeting entry standards after two attempts during the Baseline CCTA visit as assessed by the imaging core lab.
- Uncontrolled severe hypertension: systolic blood pressure > 180 mmHg or diastolic BP > 100 mm Hg prior to randomization (assessed at the screening visit) despite antihypertensive therapy
- Heart Failure NYHA Class III or IV at the screening visit
- Renal insufficiency (eGFR <40 ml/min/1.73m2) as measured by the Modification of Diet in Renal Disease (MDRD) formula at the screening visit.
- Hospitalization for major cardiovascular event including heart failure in the past 2 months
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center (The Lundquist Institute)
Torrance, California, 90502
Matthew Budoff, MD, 310-222-4107, mbudoff@lundquist.org
Sajad Hamal, MS, 310-974-9336, shamal@lundquist.org
About this study
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.
Read the detailed description
This is a multi-center study in which 120 male and female participants who meet the eligibility criteria will be randomized. Study will assess changes in coronary atheroma volume comparing tirzepatide 15 mg/week plus Standard of Care (SOC), as compared to placebo plus SOC. Potential eligible participants may be prescreened for eligibility prior to the screening visit and must have a diagnosis of atherosclerosis (as assessed by >10% atheroma on CCTA) and T2DM.
Patients must be on a stable medical regiment (>4 weeks on statin therapy and diabetes medications) and undergo screening CCTA to demonstrate coronary plaque. Participant eligibility will be assessed by the Imaging Core Lab.
If the participant meets all entry criteria during baseline visit, then consenting participants will be randomized 1:1 to receive tirzepatide on top of standard of care for treatment period of 12 months. Participants will be asked to maintain stable doses of statins and diabetes medications. Persistent hyperglycemia will be treated by primary physician or endocrinologist,
- Conditions
- Type II Diabetes, Atherosclerosis
- Being tested
- Tirzepatide, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirzepatideDrug
Also called Mounjaro
Tirzepatide 15mg Subcutaneous Solution
PlaceboDrug
Volume matched Subcutaneous Solution
| Study group | Role | What they receive |
|---|---|---|
| Tirzepatide | Active comparator | Tirzepatide 15mg Prefilled pen for weekly subcutaneous injection over 52 weeks Receives: Drug: Tirzepatide |
| Placebo | Placebo comparator | Placebo Prefilled pen (volume matched) for weekly subcutaneous injection over 52 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 months
Secondary outcomes (3)
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)
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start2 Jan 2024
- Primary completionDec 2025 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type II DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blind Placebo controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Matthew J. Budoff
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Sponsor-investigator, Matthew J. Budoff, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- Investigators
- Matthew A Budoff, MD, Principal investigator, The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05708859
- Sponsor's protocol ID
- 22915-01
- Acronym
- T-PLAQUE
- Status last verified
- Oct 2024
- First submitted
- 12 Jan 2023
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tirzepatide on Progression of Coronary Atherosclerosis Using MDCT
- ClinicalTrials.gov ID
- NCT05708859
- Acronym / sponsor ID
- T-PLAQUE / 22915-01
- Conditions
- Type II Diabetes, Atherosclerosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Matthew J. BudoffUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 1 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a multi-center study in which 120 male and female participants who meet the eligibility criteria will be randomized. Study will assess changes in coronary atheroma volume comparing tirzepatide 15 mg/week plus Standard of Care (SOC), as compared to placebo plus SOC. Potential eligible participants may be prescreened for eligibility prior to the screening visit and must have a diagnosis of atherosclerosis (as assessed by >10% atheroma on CCTA) and T2DM.
Patients must be on a stable medical regiment (>4 weeks on statin therapy and diabetes medications) and undergo screening CCTA to demonstrate coronary plaque. Participant eligibility will be assessed by the Imaging Core Lab.
If the participant meets all entry criteria during baseline visit, then consenting participants will be randomized 1:1 to receive tirzepatide on top of standard of care for treatment period of 12 months. Participants will be asked to maintain stable doses of statins and diabetes medications. Persistent hyperglycemia will be treated by primary physician or endocrinologist,
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blind Placebo controlled
| Arm | Type | Receives |
|---|---|---|
| Tirzepatide | Active comparator | Drug: TirzepatideTirzepatide 15mg Prefilled pen for weekly subcutaneous injection over 52 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo Prefilled pen (volume matched) for weekly subcutaneous injection over 52 weeks |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
- At the baseline visit, participants must be on a stable (>4 weeks) regiment of diabetes medications.
Key exclusion criteria (18 listed)
- 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
- Are currently planning treatment for diabetic retinopathy and/or macular edema
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TirzepatideAlso: MounjaroTirzepatide 15mg Subcutaneous Solution | Drug | Tirzepatide |
| PlaceboVolume matched Subcutaneous Solution | Drug | Placebo |
Primary outcome
Reduction of total non-calcified coronary plaque volume
Time frame: 12 months
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).
3 secondary outcomes
Reduction of low attenuation plaque volume
Time frame: 12 months
Reduction of total plaque volume, fibrous, lipid-rich and calcified plaque volumes using CCTA
Time frame: 12 months
Change in HgA1c lab values in the blood.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew A Budoff, MD principal investigator
The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tirzepatide in people with Type II Diabetes and Atherosclerosis, run by Matthew J. Budoff at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sajad Hamal, MS (13109749336, shamal@lundquist.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of total non-calcified coronary plaque volume (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.