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IDEAL-COR

Phase 1
Conditions
Overweight and obesity
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Registration Number
CTIS2023-505270-15-00
Lead Sponsor
Steno Diabetes Center Copenhagen
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
124
Inclusion Criteria

BMI equal to or above 27 kg/m2, Age 18 years or older, Referred to coronary angiography (CAG) due to stable angina, Coronary atheromatosis by angiography (obstructive or non-obstructive), Lipid core burden index (LCBI) (4mm) >200 by near-infrared spectroscopy (NIRS) in a vessel not subjected to coronary intervention

Exclusion Criteria

History of diabetes or HbA1c =48 mmol/mol (6.5%) at baseline, Family or history of multiple endocrine neoplasia (MEN) type 2 or familial medullary thyroid carcinoma (FMTC), Left main stenosis (=50% diameter or haemodynamically significant), Chronic total occlusion of any major coronary vessel, Treatment with glucagon-like peptide 1 (GLP-1) agonists, History of coronary artery bypass surgery (CABG), Planned cardiovascular intervention (including percutaneous coronary intervention, cardiac surgery or transcatheter valve intervention) at time of randomisation, History of heart failure New York Heart Association (NYHA) class III or IV, Left ventricular ejection fraction (LVEF) =35%, Estimated glomerular filtration rate (eGFR <30 ml/min/1.53 m2), History of pancreatitis or plasma amylase >3 times upper normal limit, Pregnancy or planned pregnancy

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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