Effect of Tirzepatide on Progression of Coronary Atherosclerosis Using MDCT

Part of paid clinical trials in Torrance, California.

Sponsor
Matthew J. Budoff
Study ID
NCT05708859
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Tirzepatide — DRUG
    Tirzepatide 15mg Subcutaneous Solution
  • Placebo — DRUG
    Volume matched Subcutaneous Solution

Study Details

A multi-center, randomized, double-blind, placebo-controlled, parallel-group phase IV Study evaluating the effects of tirzepatide on atherosclerotic plaque progression assessed by coronary computed tomography angiography (CCTA) in participants with a diagnosis of type II Diabetes (T2DM) and atherosclerosis.

Key Dates

Start date
Jan 2, 2024
Status verified
Oct 2024
Primary completion
Dec 31, 2025
Completion
May 31, 2026

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Active Comparator: Tirzepatide
    Tirzepatide 15mg Prefilled pen for weekly subcutaneous injection over 52 weeks
  • Placebo Comparator: Placebo
    Placebo Prefilled pen (volume matched) for weekly subcutaneous injection over 52 weeks

Primary Outcome Measure

Reduction of total non-calcified coronary plaque volume [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center (The Lundquist Institute)TorranceCalifornia90502
Matthew Budoff, MD
[email protected]
310-222-4107
Sajad Hamal, MS
[email protected]
310-974-9336
Matthew J Budoff, MD (PRINCIPAL_INVESTIGATOR)

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Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center (The Lundquist Institute)· Torrance, CA

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