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Trial · Interventional

RecruitingPhase 4Registry data

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

Short name IDEAL-COR

NCTNCT06606821 (opens ClinicalTrials.gov in a new tab)Other id2023-505270-15-00Other id2023-505270-15-00Other id2023
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Recruiting
Phase
Phase 4
Enrollment
124 participants (estimated)
Sponsor
Tina Vilsbøll · Other
Design
Randomized · Triple masking
Countries
1 country

Denmark

Start
1 Oct 2024
Primary completion
20 Mar 2027 (estimated)
Completion
1 Aug 2028 (estimated)
First posted
23 Sept 2024
Last update posted
22 May 2025
Conditions
Coronary Artery Disease · Coronary Microvascular Dysfunction · Overweight or Obesity · Stable Angina Pectoris · Chronic Coronary Artery Disease · Atherosclerosis Cardiovascular Disease

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202420252026202720282029
  1. Ph 4

    IDEAL-COR

    NCT06606821

    1 Oct 2024 to est. 1 Aug 2028

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • TirzepatideDrug
  • PlaceboDrug

Arms2

  • Experimental

    Tirzepatide

    Tirzepatide is administered sc. once-weekly.

  • Placebo comparator

    Placebo

    Placebo is administered sc. once-weekly.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Lipid core burden index

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

    Registry description

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

Secondary outcomes(3)

  1. Percent atheroma volume (PAV)

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

    Registry description

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

  2. 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:

    Registry description

    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%

  3. Coronary flow reserve

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

    Registry description

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies8

Studies that cite this trial.

Studies with results

7 studies on this page

Indexing hint: Randomized controlled trial · 2022

6 results

Tirzepatide Once Weekly for the Treatment of Obesity.

Jastreboff et al. 2022The New England journal of medicinecited by 2,802

PMID 35658024DOI 10.1056/nejmoa2206038PUB-35658024

Full text at the publisher6 results
Publisher pageSee results (6)

Indexing hint: Randomized controlled trial · 2021

19 results

Tirzepatide versus Semaglutide Once Weekly in Patients with Type 2 Diabetes.

Frías et al. 2021The New England journal of medicinecited by 1,535

PMID 34170647DOI 10.1056/nejmoa2107519PUB-34170647

Full text at the publisher19 results
Publisher pageSee results (19)

Indexing hint: Randomized controlled trial · 2019

3 results

Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial.

Gerstein et al. 2019Lancet (London, England)cited by 2,264

PMID 31189511DOI 10.1016/s0140-6736(19)31149-3PUB-31189511

Full text at the publisher3 results
Publisher pageSee results (3)

Indexing hint: Randomized controlled trial · 2018

33 results

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.

Frias et al. 2018Lancet (London, England)cited by 651

PMID 30293770DOI 10.1016/s0140-6736(18)32260-8PUB-30293770

Full text at the publisher33 results
Publisher pageSee results (33)

Indexing hint: Randomized controlled trial · 2018

10 results

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.

Coskun et al. 2018Molecular metabolismcited by 700

PMID 30473097PMC6308032DOI 10.1016/j.molmet.2018.09.009PUB-30473097

Free to read · publisher termsCC BY-NC-ND10 results
Read at sourceSee results (10)

Indexing hint: Randomized controlled trial · 2016

8 results

Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes.

Marso et al. 2016The New England journal of medicinecited by 5,535

PMID 27295427PMC4985288DOI 10.1056/nejmoa1603827PUB-27295427

Rights unknown8 results
Source linkSee results (8)

Indexing hint: Randomized controlled trial · 2016

8 results

Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes.

Marso et al. 2016The New England journal of medicinecited by 5,002

PMID 27633186DOI 10.1056/nejmoa1607141PUB-27633186

Rights unknown8 results
Source linkSee results (8)

More studies

1 study on this page

Indexing hint: Meta-analysis (pooled) · 2019

Corrected

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.

Kristensen et al. 2019The lancet. Diabetes & endocrinologycited by 1,238

PMID 31422062DOI 10.1016/s2213-8587(19)30249-9PUB-31422062

Rights unknown
Source linkRead the notice

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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