IDEAL-COR

RecruitingPhase 4

The Effects of Tirzepatide in People With Overweight/Obesity and Coronary Artery Disease

The Effects of Tirzepatide on Coronary Plaque Lipid Content and Myocardial Microvascular Function in Overweight and Obese People With Coronary Disease - The IDEAL-COR Study

Lead sponsor

Tina Vilsbøll

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

Enrollment

124

estimated

Study population

Cardiovascular disease, Obesity / overweight

Key I/E criterion

•BMI ≥27

Primary endpoint

•Lipid core burden index

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06606821

Org study ID2023-505270-15-00

Timeline

Milestones

Study first posted2024-09-23actual

Study start2024-10-01actual

Last update posted2025-05-22actual

Primary completion2027-03-20estimated

Study completion2028-08-01estimated

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Cardiovascular diseaseObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Informed written consent

•BMI equal to or above 27 kg/m2

•Age 18 years or older

•Referred to coronary angiogram (CAG) due to stable angina

•Coronary atheromatosis by angiography (obstructive or non-obstructive)

•LCBI4mm >200 by NIRS in a vessel not subjected to coronary intervention

Exclusion criteria

•History of diabetes or HbA1c ≥48 mmol/mol (6.5%) at baseline

•Treatment with Glucagon-Like Peptide-1 Receptor Agonists (GLP-1RA)

•History of coronary artery bypass surgery (CABG)

•Planned CV 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%

•eGFR <30 ml/min/1.53 m2

•History of pancreatitis or plasma amylase >2 times upper normal limit

•Impaired hepatic function at baseline (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 times the upper limit of normal)

•Pregnancy, planned pregnancy or breastfeeding

•Family or history of multiple endocrine neoplasia (MEN) type 2 or familial medullary thyroid carcinoma (FMTC)

•Hypersensitivity to the active substance (Tirzepatide) or to any of the excipients

•Left main stenosis (≥50% diameter or haemodynamically significant)

•Chronic total occlusion of any major coronary vessel

•Multi-vessel disease or complex anatomy potentially requiring coronary bypass surgery

•Coronary anatomy or pathology precluding the safe performance of intravascular imaging in all major coronary arteries not subjected to intervention

Endpoints (23)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Glycemic / diabetes

MASH / liver

Cardiometabolic biomarkers

Cardiovascular outcomes

Patient-reported / QoL

Weight & body composition

Cardiovascular outcomes

2 endpoints

Primary/protocol endpoint/low confidence

Lipid core burden index

Time frame:Between-group difference in change from baseline to week 52 in participants treated with tirzepatide vs placebo:

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Number of high-risk coronary lesion

Time frame:Between-group difference in change from baseline to week 52 in participants treated with tirzepatide vs placebo:

change from baseline, improvement

Weight & body composition

1 endpoint

Other/protocol endpoint

Body composition assessed by DXA scan:

Time frame:Between-group difference in change from baseline to week 52 in participants treated with tirzepatide vs placebo:

Visceral fat, change

change from baseline, improvement

Glycemic / diabetes

5 endpoints

Other/protocol endpoint

Homeostatic Model Assessment for Insulin Resistance

Time frame:Between-group difference in change from baseline to week 52 in participants treated with tirzepatide vs placebo:

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Other/protocol endpoint

Glycaemic profile

Time frame:Between-group difference in change from baseline to week 52 in participants treated with tirzepatide vs placebo:

change from baseline, improvement

componentsCGM time-in-range, Fasting glucose, change, HbA1c, change

Other/protocol endpoint/low confidence

Change in glycaemic variability

Time frame:Between-group difference in change from baseline to week 52 in participants treated with tirzepatide vs placebo:

change from baseline, improvement

Other/protocol endpoint

Change in fasting plasma glucose

Time frame:Between-group difference in change from baseline to week 52 in participants treated with tirzepatide vs placebo:

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Other/protocol endpoint

Change in glycated haemoglobin A1c

Time frame:Between-group difference in change from baseline to week 52 in participants treated with tirzepatide vs placebo:

HbA1c, change

change from baseline, improvement

LOINC 4548-4

MASH / liver

3 endpoints

Other/protocol endpoint

Liver stiffness measurement

Time frame:Between-group difference in change from baseline to week 52 in participants treated with tirzepatide vs placebo:

Liver stiffness (VCTE), change

change from baseline, improvement

Other/protocol endpoint

Controlled Attenuation Parameter

Time frame:Between-group difference in change from baseline to week 52 in participants treated with tirzepatide vs placebo:

change from baseline, improvement

Other/protocol endpoint

Fibrosis-4 score

Time frame:Between-group difference in change from baseline to week 52 in participants treated with tirzepatide vs placebo:

change from baseline, improvement

Cardiometabolic biomarkers

3 endpoints

Secondary/protocol endpoint

Percent atheroma volume (PAV)

Time frame:Between-group difference in change from baseline to week 52 in participants treated with tirzepatide vs placebo:

change from baseline, improvement

Other/protocol endpoint

Plasma lipid profile

Time frame:Between-group difference in change from baseline to week 52 in participants treated with tirzepatide vs placebo:

change from baseline, improvement

Other/protocol endpoint

Markers of inflammation

Time frame:Between-group difference in change from baseline to week 52 in participants treated with tirzepatide vs placebo:

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Patient-reported / QoL

2 endpoints

Other/protocol endpoint

Seattle Angina Questionnaire-7

Time frame:Between-group difference in change from baseline to week 52 in participants treated with tirzepatide vs placebo:

change from baseline, improvement

Other/protocol endpoint

EuroQoL 5-Dimension 5-Level

Time frame:Between-group difference in change from baseline to week 52 in participants treated with tirzepatide vs placebo:

EQ-5D index

change from baseline, improvement

Other (unclassified)

7 endpoints

Secondary/protocol endpoint/low confidence

Coronary flow reserve

Time frame:Between-group difference in change from baseline to week 52 in participants treated with tirzepatide vs placebo:

change from baseline, improvement

Other/protocol endpoint/low confidence

Left ventricular systolic and diastolic function assessed by echocardiography:

Time frame:Between-group difference in change from baseline to week 52 in participants treated with tirzepatide vs placebo:

change from baseline, improvement

Other/protocol endpoint/low confidence

Urine markers of oxidative stress

Time frame:Between-group difference in change from baseline to week 52 in participants treated with tirzepatide vs placebo:

change from baseline, improvement

Other/protocol endpoint/low confidence

Myocardial work

Time frame:Between-group difference in change from baseline to week 52 in participants treated with tirzepatide vs placebo:

change from baseline, descriptive

Other/protocol endpoint/low confidence

Thromboelastography

Time frame:Between-group difference in change from baseline to week 52 in participants treated with tirzepatide vs placebo:

change from baseline, descriptive

Other/protocol endpoint/low confidence

Index of microcirculatory resistance

Time frame:Between-group difference in change from baseline to week 52 in participants treated with tirzepatide vs placebo

change from baseline, improvement

Other/protocol endpoint/low confidence

Resistive Reserve Ratio

Time frame:Between-group difference in change from baseline to week 52 in participants treated with tirzepatide vs placebo

change from baseline, improvement

Publications (39)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Optical coherence tomography-derived lipid core burden index and clinical outcomes: results from the CLIMA registry.
European heart journal. Cardiovascular Imaging2023 Mar 21PMID35718858doi:10.1093/ehjci/jeac110via CT.gov background
6. Glycemic Targets: Standards of Care in Diabetes-2023.
Diabetes care2023 Jan 1PMID36507646doi:10.2337/dc23-S006via CT.gov background
Tirzepatide Once Weekly for the Treatment of Obesity.
The New England journal of medicine2022 Jul 21PMID35658024doi:10.1056/NEJMoa2206038via CT.gov background
Using Participatory Methods to Assess PrEP Interest and Uptake Among Young People Living in the Southeastern US: A Mixed Methods Assessment.
AIDS and behavior2022 May (month)PMID34724592doi:10.1007/s10461-021-03519-yvia CT.gov background
Tirzepatide versus Semaglutide Once Weekly in Patients with Type 2 Diabetes.
The New England journal of medicine2021 Aug 5PMID34170647doi:10.1056/NEJMoa2107519via CT.gov background
Global Burden of Cardiovascular Diseases and Risk Factors, 1990-2019: Update From the GBD 2019 Study.
Journal of the American College of Cardiology2020 Dec 22PMID33309175doi:10.1016/j.jacc.2020.11.010via CT.gov background
The role of overweight and obesity in adverse cardiovascular disease mortality trends: an analysis of multiple cause of death data from Australia and the USA.
BMC medicine2020 Aug 4PMID32746822doi:10.1186/s12916-020-01666-yvia CT.gov background
Low-density lipoproteins cause atherosclerotic cardiovascular disease: pathophysiological, genetic, and therapeutic insights: a consensus statement from the European Atherosclerosis Society Consensus Panel.
European heart journal2020 Jun 21PMID32052833doi:10.1093/eurheartj/ehz962via CT.gov background
CAV1-CAVIN1-LC3B-mediated autophagy regulates high glucose-stimulated LDL transcytosis.
Autophagy2020 Jun (month)PMID31448673doi:10.1080/15548627.2019.1659613via CT.gov background
Obesity Phenotypes, Diabetes, and Cardiovascular Diseases.
Circulation research2020 May 22PMID32437302doi:10.1161/CIRCRESAHA.120.316101via CT.gov background
Is the long-term decline in cardiovascular-disease mortality in high-income countries over? Evidence from national vital statistics.
International journal of epidemiology2019 Dec 1PMID31378814doi:10.1093/ije/dyz143via CT.gov background
Cardiovascular, mortality, and kidney outcomes with GLP-1 receptor agonists in patients with type 2 diabetes: a systematic review and meta-analysis of cardiovascular outcome trials.
The lancet. Diabetes & endocrinology2019 Oct (month)PMID31422062doi:10.1016/S2213-8587(19)30249-9via CT.gov background
Heterogeneity and Similarities in GLP-1 Receptor Agonist Cardiovascular Outcomes Trials.
Trends in endocrinology and metabolism: TEM2019 Sep (month)PMID31401015doi:10.1016/j.tem.2019.07.004via CT.gov background
Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial.
Lancet (London, England)2019 Jul 13PMID31189511doi:10.1016/S0140-6736(19)31149-3via CT.gov background
Effect of Alirocumab and Rosuvastatin or Rosuvastatin Alone on Lipid Core Plaque in Coronary Artery Disease Seen on Near-Infrared Spectroscopy Intravascular Ultrasound (ANTARES).
Circulation reports2019 Jan 31PMID33693121doi:10.1253/circrep.CJ-18-0021via CT.gov background
LY3298176, a novel dual GIP and GLP-1 receptor agonist for the treatment of type 2 diabetes mellitus: From discovery to clinical proof of concept.
Molecular metabolism2018 Dec (month)PMID30473097doi:10.1016/j.molmet.2018.09.009via CT.gov background
Efficacy and safety of LY3298176, a novel dual GIP and GLP-1 receptor agonist, in patients with type 2 diabetes: a randomised, placebo-controlled and active comparator-controlled phase 2 trial.
Lancet (London, England)2018 Nov 17PMID30293770doi:10.1016/S0140-6736(18)32260-8via CT.gov background
Albiglutide and cardiovascular outcomes in patients with type 2 diabetes and cardiovascular disease (Harmony Outcomes): a double-blind, randomised placebo-controlled trial.
Lancet (London, England)2018 Oct 27PMID30291013doi:10.1016/S0140-6736(18)32261-Xvia CT.gov background
Endothelial permeability, LDL deposition, and cardiovascular risk factors-a review.
Cardiovascular research2018 Jan 1PMID29228169doi:10.1093/cvr/cvx226via CT.gov background
High-density lipoprotein cholesterol associated with change in coronary plaque lipid burden assessed by near infrared spectroscopy.
Atherosclerosis2017 Oct (month)PMID28881268doi:10.1016/j.atherosclerosis.2017.08.016via CT.gov background
Intracoronary Imaging, Cholesterol Efflux, and Transcriptomes After Intensive Statin Treatment: The YELLOW II Study.
Journal of the American College of Cardiology2017 Feb 14PMID27989886doi:10.1016/j.jacc.2016.10.029via CT.gov background
Obesity and cardiovascular disease: friend or foe?
European heart journal2016 Dec 21PMID26685971doi:10.1093/eurheartj/ehv509via CT.gov background
Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes.
The New England journal of medicine2016 Nov 10PMID27633186doi:10.1056/NEJMoa1607141via CT.gov background
Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes.
The New England journal of medicine2016 Jul 28PMID27295427doi:10.1056/NEJMoa1603827via CT.gov background
Trends in adult body-mass index in 200 countries from 1975 to 2014: a pooled analysis of 1698 population-based measurement studies with 19·2 million participants.
Lancet (London, England)2016 Apr 2PMID27115820doi:10.1016/S0140-6736(16)30054-Xvia CT.gov background
Increased GIP signaling induces adipose inflammation via a HIF-1α-dependent pathway and impairs insulin sensitivity in mice.
American journal of physiology. Endocrinology and metabolism2015 Mar 1PMID25537494doi:10.1152/ajpendo.00418.2014via CT.gov background
Effect of high-intensity statin therapy on atherosclerosis in non-infarct-related coronary arteries (IBIS-4): a serial intravascular ultrasonography study.
European heart journal2015 Feb 21PMID25182248doi:10.1093/eurheartj/ehu373via CT.gov background
Combined IVUS and NIRS detection of fibroatheromas: histopathological validation in human coronary arteries.
JACC. Cardiovascular imaging2015 Feb (month)PMID25577445doi:10.1016/j.jcmg.2014.09.021via CT.gov background
Role of near-infrared spectroscopy in intravascular coronary imaging.
Cardiovascular revascularization medicine : including molecular interventions2015 Jul-Aug (year)PMID26242984doi:10.1016/j.carrev.2015.06.001via CT.gov background
Adipokines: a link between obesity and cardiovascular disease.
Journal of cardiology2014 Apr (month)PMID24355497doi:10.1016/j.jjcc.2013.11.006via CT.gov background
Arterial stiffening precedes systolic hypertension in diet-induced obesity.
Hypertension (Dallas, Tex. : 1979)2013 Dec (month)PMID24060894doi:10.1161/HYPERTENSIONAHA.113.01744via CT.gov background
Changes in plaque lipid content after short-term intensive versus standard statin therapy: the YELLOW trial (reduction in yellow plaque by aggressive lipid-lowering therapy).
Journal of the American College of Cardiology2013 Jul 2PMID23644090doi:10.1016/j.jacc.2013.03.058via CT.gov background
Subsequent development of fibroatheromas with inflamed fibrous caps can be predicted by intracoronary near infrared spectroscopy.
Arteriosclerosis, thrombosis, and vascular biology2013 Feb (month)PMID23288155doi:10.1161/ATVBAHA.112.300710via CT.gov background
Should C-reactive protein be a target of therapy?
Diabetes care2011 May (month)PMID21525448doi:10.2337/dc11-s211via CT.gov background
Increased expression and secretion of resistin in epicardial adipose tissue of patients with acute coronary syndrome.
American journal of physiology. Heart and circulatory physiology2010 Mar (month)PMID20061546doi:10.1152/ajpheart.00617.2009via CT.gov background
Claudin-16 and claudin-19 interact and form a cation-selective tight junction complex.
The Journal of clinical investigation2008 Feb (month)PMID18188451doi:10.1172/JCI33970via CT.gov background
Obesity is associated with macrophage accumulation in adipose tissue.
The Journal of clinical investigation2003 Dec (month)PMID14679176doi:10.1172/JCI19246via CT.gov background
Lessons from sudden coronary death: a comprehensive morphological classification scheme for atherosclerotic lesions.
Arteriosclerosis, thrombosis, and vascular biology2000 May (month)PMID10807742doi:10.1161/01.atv.20.5.1262via CT.gov background
Cigarette smoking and progression of atherosclerosis: The Atherosclerosis Risk in Communities (ARIC) Study.
JAMA1998 Jan 14PMID9440661doi:10.1001/jama.279.2.119via CT.gov background

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.