Ideal-Cor

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Steno Diabetes Center Copenhagen

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

Trial duration

19 Aug 2024 → ongoing

Decision date (initial)

2024-07-03

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2023-505270-15-00

ClinicalTrials.gov

NCT06606821

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Prophylaxis

To investigate the effects of tirzepatide once-weekly vs. placebo on changes in coronary plaque composition and progression, plaque burden, and microvascular function in overweight and obese individuals with stable coronary artery disease.

Conditions and MedDRA coding

Overweight and obesity

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. BMI equal to or above 25 kg/m2
2. Age 18 years or older
3. Referred to coronary angiography (CAG) for evaluation of stable coronary disease
4. Coronary atheromatosis by angiography (obstructive or non-obstructive)
5. 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 22

1. History of diabetes or HbA1c ≥48 mmol/mol (6.5%) at screening
2. Family or history of multiple endocrine neoplasia (MEN) type 2 or familial medullary thyroid carcinoma (FMTC)
3. Left main stenosis (≥50% diameter or haemodynamically significant)
4. Chronic total occlusion of any major coronary vessel
5. Treatment with glucagon-like peptide 1 (GLP-1) agonists
6. History of coronary artery bypass surgery (CABG)
7. Planned cardiovascular intervention (including percutaneous coronary intervention, cardiac surgery or transcatheter valve intervention) at time of screening or at randomisation
8. History of heart failure New York Heart Association (NYHA) class III or IV
9. Left ventricular ejection fraction (LVEF) ≤35%
10. Estimated glomerular filtration rate (eGFR <30 ml/min/1.53 m2)
11. History of pancreatitis or plasma amylase >3 times upper normal limit
12. Pregnancy or planned pregnancy
13. Impaired hepatic function at baseline (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 times the upper limit of normal)
14. Heart transplant recipient
15. Patient is currently enrolled in another research study that may interfere with the conduct of this study.
16. 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.
17. Inability to understand the requirements of the study and to provide informed consent
18. Medical illness requiring long-term treatment with systemic glucocorticoidsteroids
19. Patients who will not be available for study-required visits in the judgment of the Investigator
20. Coronary disease requiring coronary bypass surgery
21. Coronary disease requiring complex or high-risk PCI (e.g. chronic total occlusion of a major vessel or need for extensive rotablation).
22. Coronary anatomy or pathology precluding the safe performance of intravascular imaging in at least one major vessel not subjected to intervention

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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.

Secondary endpoints 3

1. 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)
2. 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%
3. 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)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Steno Diabetes Center Copenhagen

Sponsor organisation

Steno Diabetes Center Copenhagen

Address

Borgmester Ib Juuls Vej 83

City

Herlev

Postcode

2730

Country

Denmark

Scientific contact point

Organisation

Steno Diabetes Center Copenhagen

Contact name

Christine Rode

Public contact point

Organisation

Steno Diabetes Center Copenhagen

Contact name

Christine Rode

Third parties 1

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 13 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications