Tirzepatide for Overweight | Obesity | Coronary artery disease

Inclusion criteria

• {"criterion_text":"- BMI equal to or above 25 kg/m2\n- Age 18 years or older\n- Referred to coronary angiography (CAG) for evaluation of stable coronary disease\n- Coronary atheromatosis by angiography (obstructive or non-obstructive)\n- max lipid core burden index 4 mm (maxLCBI4mm) >200 by near-infrared spectroscopy (NIRS) in at least one major vessel not subjected to coronary intervention"}

Exclusion criteria

• {"criterion_text":"- History of diabetes or HbA1c ≥48 mmol/mol (6.5%) at screening\n- Estimated glomerular filtration rate (eGFR <30 ml/min/1.53 m2)\n- History of pancreatitis or plasma amylase >3 times upper normal limit\n- Pregnancy or planned pregnancy\n- Impaired hepatic function at baseline (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 times the upper limit of normal)\n- Heart transplant recipient\n- Patient is currently enrolled in another research study that may interfere with the conduct of this study.\n- Patient has any medical illness (e.g. cancer) that may cause non-compliance with the protocol or is associated with a life expectancy less than 1 year.\n- Inability to understand the requirements of the study and to provide informed consent\n- Medical illness requiring long-term treatment with systemic glucocorticoidsteroids\n- Patients who will not be available for study-required visits in the judgment of the Investigator\n- Family or history of multiple endocrine neoplasia (MEN) type 2 or familial medullary thyroid carcinoma (FMTC)\n- Coronary disease requiring coronary bypass surgery\n- Coronary disease requiring complex or high-risk PCI (e.g. chronic total occlusion of a major vessel or need for extensive rotablation).\n- Coronary anatomy or pathology precluding the safe performance of intravascular imaging in at least one major vessel not subjected to intervention\n- Left main stenosis (≥50% diameter or haemodynamically significant)\n- Chronic total occlusion of any major coronary vessel\n- Treatment with glucagon-like peptide 1 (GLP-1) agonists\n- History of coronary artery bypass surgery (CABG)\n- Planned cardiovascular intervention (including percutaneous coronary intervention, cardiac surgery or transcatheter valve intervention) at time of screening or at randomisation\n- History of heart failure New York Heart Association (NYHA) class III or IV\n- Left ventricular ejection fraction (LVEF) ≤35%"}

Primary endpoints

• {"endpoint_text":"- Between-group difference in change from baseline to week 52 in participants treated with tirzepatide vs placebo: Lipid core burden index of the three major coronary vessels (LCBI(total)) measured by NIRS imaging.","definition_or_measurement_approach":"Measured by near-infrared spectroscopy (NIRS) imaging; change from baseline to week 52 compared between tirzepatide and placebo arms."}

Secondary endpoints

• {"endpoint_text":"- Between-group difference in change from baseline to week 52 in participants treated with tirzepatide vs placebo: Total coronary plaque burden measured by coronary intravascular ultrasound (IVUS) imaging assessed by percent atheroma volume (PAV)","definition_or_measurement_approach":"Measured by coronary intravascular ultrasound (IVUS); assessed by percent atheroma volume (PAV), change from baseline to week 52."}
• {"endpoint_text":"- Between-group difference in change from baseline to week 52 in participants treated with tirzepatide vs placebo: Number of high-risk coronary lesions characterized by maximum lipid core burden index of a 4 mm examined vessel (maxLCBI(4mm)) ≥325 and plaque burden ≥70%","definition_or_measurement_approach":"Count of lesions meeting criteria (maxLCBI(4mm) ≥325 and plaque burden ≥70%) at baseline and week 52; between-group comparison."}
• {"endpoint_text":"- Between-group difference in change from baseline to week 52 in participants treated with tirzepatide vs placebo microvascular function assessed by invasive coronary thermodilution technique (CFR)","definition_or_measurement_approach":"Microvascular function assessed by invasive coronary thermodilution technique (coronary flow reserve, CFR); change from baseline to week 52 compared between arms."}

Denmark

Earliest CTIS Part Ii Submission Date

01-07-2024

Latest Decision Or Authorization Date

12-04-2026

Processing Time Days

650

Number Of Sites

2

Number Of Participants

124

Primary sponsor

Full Name

Steno Diabetes Center Copenhagen

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"codes: 1, 12","organisation_type":"Hospital/Clinic/Other health care facility"}