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

Sponsor
Tina Vilsbøll
Study ID
NCT06606821
Phase
PHASE4
Status
Recruiting
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Conditions

  • Atherosclerosis Cardiovascular Disease
  • Chronic Coronary Artery Disease
  • Coronary Artery Disease
  • Coronary Microvascular Dysfunction
  • Overweight or Obesity
  • Stable Angina Pectoris

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Oct 1, 2024
Status verified
May 2025
Primary completion
Mar 20, 2027
Completion
Aug 1, 2028

Study Design

Enrollment
124 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tirzepatide
    Tirzepatide is administered sc. once-weekly.
  • Placebo Comparator: Placebo
    Placebo is administered sc. once-weekly.

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: ]

Central Contacts

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