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

NCT06606821 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2025-05-22

No results posted yet for this study

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 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.

Conditions

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

Interventions

DRUG

Tirzepatide

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

DRUG

Placebo

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

Sponsors & Collaborators

  • Tina Vilsbøll

    lead OTHER

Principal Investigators

  • Tina Vilsbøll, MD, DMSc · Steno Diabetes Center Copenhagen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-01
Primary Completion
2027-03-20
Completion
2028-08-01

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06606821 on ClinicalTrials.gov