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

ConditionsCoronary Artery DiseaseCoronary Microvascular DysfunctionOverweight or ObesityStable Angina PectorisChronic Coronary Artery DiseaseAtherosclerosis Cardiovascular Disease
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorTina Vilsbøll

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tirzepatide

    Drug

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

  • Placebo

    Drug

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

Treatment groups

124 Participants
are divided into 2 treatment groups
Group A: TirzepatideExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Lipid core burden index

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

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

Secondary outcomes

1

Percent atheroma volume (PAV)

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

Time frame
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%

Time frame
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.

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

Other outcomes

1

Plasma lipid profile

Total cholesterol (TC) Triglyceride (TG) High-density lipoprotein cholesterol (HDL-C) LDL-C

Time frame
Between-group difference in change from baseline to week 52 in participants treated with tirzepatide vs placebo:
2

Markers of inflammation

High-sensitive C-reactive protein (hsCRP) Interleukin-6 (IL-6)

Time frame
Between-group difference in change from baseline to week 52 in participants treated with tirzepatide vs placebo:
3

Left ventricular systolic and diastolic function assessed by echocardiography:

Global longitudinal strain (GLS) measured by speckle tracking E/e' measured by tissue-Doppler

Time frame
Between-group difference in change from baseline to week 52 in participants treated with tirzepatide vs placebo:
4

Body composition assessed by DXA scan:

Regional visceral adipose tissue (VAT) Bone density

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tina Vilsbøll

Lead sponsor

Steno Diabetes Center Copenhagen

Sponsor institution

Source ClinicalTrials.gov
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