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The effects of tirzepatIDE on coronAry pLaque lipid content and myocardial microvascular function in people with overweight or obesity and CORonary disease

Status
Recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-505270-15-00
Enrollment
124
Registered
2024-07-03
Start date
2024-08-19
Completion date
Unknown
Last updated
2025-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight and obesity

Brief summary

Between-group difference in change from baseline to week 52 in participants treated with tirzepatide vs placebo: Lipid core burden index of the three major coronary vessels (LCBI(total)) measured by NIRS imaging.

Detailed description

Between-group difference in change from baseline to week 52 in participants treated with tirzepatide vs placebo: Total coronary plaque burden measured by coronary intravascular ultrasound (IVUS) imaging assessed by percent atheroma volume (PAV), Between-group difference in change from baseline to week 52 in participants treated with tirzepatide vs placebo: Number of high-risk coronary lesions characterized by maximum lipid core burden index of a 4 mm examined vessel (maxLCBI(4mm)) ≥325 and plaque burden ≥70%, Between-group difference in change from baseline to week 52 in participants treated with tirzepatide vs placebo microvascular function assessed by invasive coronary thermodilution technique (CFR)

Interventions

DRUGSALINE
DRUGMounjaro 15 mg solution for injection in pre-filled pen

Sponsors

Steno Diabetes Center Copenhagen
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Between-group difference in change from baseline to week 52 in participants treated with tirzepatide vs placebo: Lipid core burden index of the three major coronary vessels (LCBI(total)) measured by NIRS imaging.

Secondary

MeasureTime frame
Between-group difference in change from baseline to week 52 in participants treated with tirzepatide vs placebo: Total coronary plaque burden measured by coronary intravascular ultrasound (IVUS) imaging assessed by percent atheroma volume (PAV), Between-group difference in change from baseline to week 52 in participants treated with tirzepatide vs placebo: Number of high-risk coronary lesions characterized by maximum lipid core burden index of a 4 mm examined vessel (maxLCBI(4mm)) ≥325 and plaque burden ≥70%, Between-group difference in change from baseline to week 52 in participants treated with tirzepatide vs placebo microvascular function assessed by invasive coronary thermodilution technique (CFR)

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026