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

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

Treatments tested in this trial

  • Tirzepatide
  • Placebo

Treatment groups

124 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Tina Vilsbøll

Lead sponsor

Steno Diabetes Center Copenhagen

Sponsor institution