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Coronary Artery DiseasePhase 4IDEAL-CORNCT06606821

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

A Phase 4 study testing Tirzepatide in people with Coronary Artery Disease and Coronary Microvascular Dysfunction, run by Tina Vilsbøll at 3 sites in Denmark.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The objective of this study is to investigate, as a proof-of-principle, long-term (52 weeks) effects of tirzepatide once-weekly vs. placebo on changes in coronary plaque composition and progression (assessed by NIRS), plaque burden (assessed by IVUS) and microvascular function (assessed by invasively measured CFR) in… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Tirzepatide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
124 participants
Where
3 sitesDenmark
Study dates
1 Oct 2024to 1 Aug 2028
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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%
Show all 16Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Daniel Raaschou-Oddershede, MD contact

+4520157448

daniel.raaschou-oddershede@regionh.dk

Christine Rode Schwarz, MD, PhD contact

christine.rode.schwarz@regionh.dk

Denmark3 sites, 3 recruiting

  • Rigshospitalet

    Copenhagen, 2100

    Thomas Engstrøm, MD, +45 35458444, thomas.engstroem@regionh.dk

    Thomas Engstrøm, DMSci, PhD

    Not yet recruiting

  • Gentofte Hospital

    Gentofte Municipality, 2900

    Niels Thue Olsen, MD, PhD, +45 38672560, niels.thue.olsen@regionh.dk

    Niels Thue Olsen, MD, PhD

    Recruiting

  • Steno Diabetes Center Copenhagen

    Herlev, 2730

    Daniel Raaschou-Oddershede, MD, 20157448, daniel.raaschou-oddershede@regionh.dk

    Recruiting

Other trials in Denmark

About this study

Official title: 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

The objective of this study is to investigate, as a proof-of-principle, long-term (52 weeks) effects of tirzepatide once-weekly vs. placebo on changes in coronary plaque composition and progression (assessed by NIRS), plaque burden (assessed by IVUS) and microvascular function (assessed by invasively measured CFR) in overweight and obese individuals with stable coronary artery disease (CAD). In addition, the objective of a baseline cross-sectional sub-study is to explore potential metabolic and cardiovascular (CV) predictors for high arteriosclerotic plaque burden in overweight and obese individuals and to establish a cohort for future research projects.

Read the detailed description

The anti-atherogenic effect of tirzepatide has been studied in preclinical studies and seems to involve mechanisms related to a reduction in vascular inflammation and lipid accumulation. Any direct anti-atherogenic effect of tirzepatide may potentially reduce the incidence of major cardiovascular endpoints in individuals with overweight or obesity. As a proof of principle, it would be of scientific and clinical interest to explore the anti-atherogenic effect of tirzepatide in humans. IVUS-NIRS imaging is uniquely suited for this purpose, as it makes it possible to detect changes in not only atheroma burden by IVUS but also to detect progression within the plaques in the lipidic/necrotic core component by NIRS. LCBItotal allows for consecutive detection of small changes in the same individual, which is pivotal to explore the supposed antiatherogenic mechanism of tirzepatide with enough statistical power.

The investigators hypothesize that once-weekly sc. tirzepatide can reduce coronary lipid accumulation in the arterial wall and the progression of atheromatosis in individuals with overweight or obesity and established high-risk atherosclerosis. The investigators aim to investigate this hypothesis in a proof-of-principle study by investigating the change in coronary plaque composition in individuals with overweight or obesity and coronary artery disease (CAD) with high-risk characteristics by NIRS imaging randomised to 52-week treatment with tirzepatide or placebo.

Being tested
Tirzepatide, Placebo
Keywords
NIRS, IVUS, GLP-1, Tirzepatide, Intravascular imagining, Stable Angina Pectoris
Medical subject headings
Coronary Artery Disease, Overweight, Obesity, Angina, Stable

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TirzepatideDrug

    Also called LY3298176

    Investigational drug will be administered as a sc. injection once-weekly.

  • PlaceboDrug

    Also called Saline

    Placebo containing the same excipients and volume as the active treatment arm but without tirzepatide will be administered as a sc. injection once-weekly.

Study groups in NCT06606821
Study groupRoleWhat they receive
TirzepatideExperimentalTirzepatide is administered sc. once-weekly.
Receives: Drug: Tirzepatide
PlaceboPlacebo comparatorPlacebo is administered sc. once-weekly.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Lipid core burden index

    Lipid core burden index of the three major coronary vessels (LCBItotal) measured by NIRS imaging.

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

Secondary outcomes (3)

  1. Percent atheroma volume (PAV)

    Total coronary plaque burden measured by coronary IVUS imaging assessed by Percent atheroma volume (PAV)

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

  2. Number of high-risk coronary lesion

    Number of high-risk coronary lesions characterized by maximum lipid core burden index of a 4 mm examined vessel (maxLCBI4mm) ≥325 and plaque burden ≥70%

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

  3. Coronary flow reserve

    Coronary flow reserve (CFR) assessed by invasive coronary thermodilution technique during coronary angiogram measures the blood flow in the epicardial arteries and the microvasculature.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2024
  2. Study start1 Oct 2024
  3. Primary completion20 Mar 2027 (estimated)
  4. Study completion1 Aug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Care provider, Investigator, Outcomes assessor
Enrolment
124 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06606821
Sponsor's protocol ID
2023-505270-15-00
Other IDs
2023-505270-15-00, 2023
Acronym
IDEAL-COR
Status last verified
May 2025
First submitted
4 Sep 2024
Last updated
22 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that underlie the results reported in the clinical trial, after de-identification will be available in accordance with Danish data regulations.

Publications

  • Jastreboff AM, Aronne LJ, Ahmad NN, Wharton S, Connery L, Alves B, Kiyosue A, Zhang S, Liu B, Bunck MC, Stefanski A; SURMOUNT-1 Investigators. Tirzepatide Once Weekly for the Treatment of Obesity. N Engl J Med. 2022 Jul 21;387(3):205-216. doi: 10.1056/NEJMoa2206038. Epub 2022 Jun 4.

    PubMed 35658024

  • Stoner MCD, Bhushan NL, Maragh-Bass AC, Mitchell JT, Riggins L, Walker M, LeMasters K, Reese B, Dearing A, Debnam S, Golin C, Lightfoot AF, Pettifor A. Using Participatory Methods to Assess PrEP Interest and Uptake Among Young People Living in the Southeastern US: A Mixed Methods Assessment. AIDS Behav. 2022 May;26(5):1672-1683. doi: 10.1007/s10461-021-03519-y. Epub 2021 Nov 1.

    PubMed 34724592

  • Coskun T, Sloop KW, Loghin C, Alsina-Fernandez J, Urva S, Bokvist KB, Cui X, Briere DA, Cabrera O, Roell WC, Kuchibhotla U, Moyers JS, Benson CT, Gimeno RE, D'Alessio DA, Haupt A. 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. Mol Metab. 2018 Dec;18:3-14. doi: 10.1016/j.molmet.2018.09.009. Epub 2018 Oct 3.

    PubMed 30473097

  • Frias JP, Nauck MA, Van J, Kutner ME, Cui X, Benson C, Urva S, Gimeno RE, Milicevic Z, Robins D, Haupt A. 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. 2018 Nov 17;392(10160):2180-2193. doi: 10.1016/S0140-6736(18)32260-8. Epub 2018 Oct 4.

    PubMed 30293770

  • Frias JP, Davies MJ, Rosenstock J, Perez Manghi FC, Fernandez Lando L, Bergman BK, Liu B, Cui X, Brown K; SURPASS-2 Investigators. Tirzepatide versus Semaglutide Once Weekly in Patients with Type 2 Diabetes. N Engl J Med. 2021 Aug 5;385(6):503-515. doi: 10.1056/NEJMoa2107519. Epub 2021 Jun 25.

    PubMed 34170647

  • Kristensen SL, Rorth R, Jhund PS, Docherty KF, Sattar N, Preiss D, Kober L, Petrie MC, McMurray JJV. 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. Lancet Diabetes Endocrinol. 2019 Oct;7(10):776-785. doi: 10.1016/S2213-8587(19)30249-9. Epub 2019 Aug 14.

    PubMed 31422062

  • Caruso I, Cignarelli A, Giorgino F. Heterogeneity and Similarities in GLP-1 Receptor Agonist Cardiovascular Outcomes Trials. Trends Endocrinol Metab. 2019 Sep;30(9):578-589. doi: 10.1016/j.tem.2019.07.004. Epub 2019 Aug 7.

    PubMed 31401015

  • ElSayed NA, Aleppo G, Aroda VR, Bannuru RR, Brown FM, Bruemmer D, Collins BS, Hilliard ME, Isaacs D, Johnson EL, Kahan S, Khunti K, Leon J, Lyons SK, Perry ML, Prahalad P, Pratley RE, Seley JJ, Stanton RC, Gabbay RA, on behalf of the American Diabetes Association. 6. Glycemic Targets: Standards of Care in Diabetes-2023. Diabetes Care. 2023 Jan 1;46(Suppl 1):S97-S110. doi: 10.2337/dc23-S006.

    PubMed 36507646

  • Gerstein HC, Colhoun HM, Dagenais GR, Diaz R, Lakshmanan M, Pais P, Probstfield J, Riesmeyer JS, Riddle MC, Ryden L, Xavier D, Atisso CM, Dyal L, Hall S, Rao-Melacini P, Wong G, Avezum A, Basile J, Chung N, Conget I, Cushman WC, Franek E, Hancu N, Hanefeld M, Holt S, Jansky P, Keltai M, Lanas F, Leiter LA, Lopez-Jaramillo P, Cardona Munoz EG, Pirags V, Pogosova N, Raubenheimer PJ, Shaw JE, Sheu WH, Temelkova-Kurktschiev T; REWIND Investigators. Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial. Lancet. 2019 Jul 13;394(10193):121-130. doi: 10.1016/S0140-6736(19)31149-3. Epub 2019 Jun 9.

    PubMed 31189511

  • Hernandez AF, Green JB, Janmohamed S, D'Agostino RB Sr, Granger CB, Jones NP, Leiter LA, Rosenberg AE, Sigmon KN, Somerville MC, Thorpe KM, McMurray JJV, Del Prato S; Harmony Outcomes committees and investigators. Albiglutide and cardiovascular outcomes in patients with type 2 diabetes and cardiovascular disease (Harmony Outcomes): a double-blind, randomised placebo-controlled trial. Lancet. 2018 Oct 27;392(10157):1519-1529. doi: 10.1016/S0140-6736(18)32261-X. Epub 2018 Oct 2.

    PubMed 30291013

  • Marso SP, Daniels GH, Brown-Frandsen K, Kristensen P, Mann JF, Nauck MA, Nissen SE, Pocock S, Poulter NR, Ravn LS, Steinberg WM, Stockner M, Zinman B, Bergenstal RM, Buse JB; LEADER Steering Committee; LEADER Trial Investigators. Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 2016 Jul 28;375(4):311-22. doi: 10.1056/NEJMoa1603827. Epub 2016 Jun 13.

    PubMed 27295427

  • Marso SP, Bain SC, Consoli A, Eliaschewitz FG, Jodar E, Leiter LA, Lingvay I, Rosenstock J, Seufert J, Warren ML, Woo V, Hansen O, Holst AG, Pettersson J, Vilsboll T; SUSTAIN-6 Investigators. Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes. N Engl J Med. 2016 Nov 10;375(19):1834-1844. doi: 10.1056/NEJMoa1607141. Epub 2016 Sep 15.

    PubMed 27633186

  • Oh J, Teoh H, Leiter LA. Should C-reactive protein be a target of therapy? Diabetes Care. 2011 May;34 Suppl 2(Suppl 2):S155-60. doi: 10.2337/dc11-s211. No abstract available.

    PubMed 21525448

  • Howard G, Wagenknecht LE, Burke GL, Diez-Roux A, Evans GW, McGovern P, Nieto FJ, Tell GS. Cigarette smoking and progression of atherosclerosis: The Atherosclerosis Risk in Communities (ARIC) Study. JAMA. 1998 Jan 14;279(2):119-24. doi: 10.1001/jama.279.2.119.

    PubMed 9440661

  • Mundi S, Massaro M, Scoditti E, Carluccio MA, van Hinsbergh VWM, Iruela-Arispe ML, De Caterina R. Endothelial permeability, LDL deposition, and cardiovascular risk factors-a review. Cardiovasc Res. 2018 Jan 1;114(1):35-52. doi: 10.1093/cvr/cvx226.

    PubMed 29228169

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tirzepatide in people with Coronary Artery Disease and Coronary Microvascular Dysfunction, run by Tina Vilsbøll at 3 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Daniel Raaschou-Oddershede, MD (+4520157448, daniel.raaschou-oddershede@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lipid core burden index (time frame: Between-group difference in change from baseline to week 52 in participants treated with tirzepatide vs placebo:). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06606821, which also lists 39 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.

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