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

NCT ID: NCT06606821

Last Updated: 2025-05-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-01
• Study Completion Date: 2028-08-01

Brief 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.

Detailed Description

The anti-atherogenic effect of tirzepatide has been studied in preclinical studies and seems to involve mechanisms related to a reduction in vascular inflammation and lipid accumulation. Any direct anti-atherogenic effect of tirzepatide may potentially reduce the incidence of major cardiovascular endpoints in individuals with overweight or obesity. As a proof of principle, it would be of scientific and clinical interest to explore the anti-atherogenic effect of tirzepatide in humans. IVUS-NIRS imaging is uniquely suited for this purpose, as it makes it possible to detect changes in not only atheroma burden by IVUS but also to detect progression within the plaques in the lipidic/necrotic core component by NIRS. LCBItotal allows for consecutive detection of small changes in the same individual, which is pivotal to explore the supposed antiatherogenic mechanism of tirzepatide with enough statistical power.

The investigators hypothesize that once-weekly sc. tirzepatide can reduce coronary lipid accumulation in the arterial wall and the progression of atheromatosis in individuals with overweight or obesity and established high-risk atherosclerosis. The investigators aim to investigate this hypothesis in a proof-of-principle study by investigating the change in coronary plaque composition in individuals with overweight or obesity and coronary artery disease (CAD) with high-risk characteristics by NIRS imaging randomised to 52-week treatment with tirzepatide or placebo.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Tirzepatide

Tirzepatide is administered sc. once-weekly.

Group Type: EXPERIMENTAL

Tirzepatide

Intervention Type: DRUG

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

Placebo

Placebo is administered sc. once-weekly.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

Interventions

Tirzepatide

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

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

LY3298176; Saline

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tina Vilsbøll

OTHER

Sponsor Role: lead

Responsible Party

Tina Vilsbøll

Professor, MD DMSc

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Tina Vilsbøll, MD, DMSc

Role: PRINCIPAL_INVESTIGATOR

Steno Diabetes Center Copenhagen

Locations

Rigshospitalet

Copenhagen, , Denmark

Site Status: NOT_YET_RECRUITING

Gentofte Hospital

Gentofte Municipality, , Denmark

Site Status: RECRUITING

Steno Diabetes Center Copenhagen

Herlev, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Daniel Raaschou-Oddershede, MD

Role: CONTACT

daniel.raaschou-oddershede@regionh.dk

+4520157448

Christine Rode Schwarz, MD, PhD

Role: CONTACT

christine.rode.schwarz@regionh.dk

Facility Contacts

Thomas Engstrøm, MD

Role: primary

thomas.engstroem@regionh.dk

+45 35458444

Niels Thue Olsen, MD, PhD

Role: primary

niels.thue.olsen@regionh.dk

+45 38672560

Daniel Raaschou-Oddershede, MD

Role: primary

daniel.raaschou-oddershede@regionh.dk

20157448

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Other Identifiers

2023-505270-15-00

Identifier Type: CTIS

Identifier Source: secondary_id

2023-505270-15-00

Identifier Type: -

Identifier Source: org_study_id