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New treatment option for Type II Diabetes
Official title Effect of Tirzepatide on Progression of Coronary Atherosclerosis Using MDCT
ClinicalTrials.gov ID: NCT05708859
What this study is testing
What is Tirzepatide?
Tirzepatide is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for type ii diabetes.
Also referred to as Mounjaro.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Time commitment: about 12 months
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 80
You may be able to join if
- 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.
You likely can't join if
- 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)
See the full eligibility criteria
- 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
- 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)
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Torrance, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Torrance, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.