Effect of Tirzepatide on Progression of Coronary Atherosclerosis Using MDCT

NCT05708859 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 22915-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type II Diabetes; Atherosclerosis

Outcome Measures

Primary Outcomes (1)

• Reduction of total non-calcified coronary plaque volume

  Reduction of total non-calcified coronary plaque volume from baseline (start of the study) till the final visit will be measured using Coronary Computed Tomography Angiography (CCTA).

  12 months

Secondary Outcomes (3)

• Reduction of low attenuation plaque volume

  12 months

• Reduction of total plaque volume, fibrous, lipid-rich and calcified plaque volumes using CCTA

  12 months

• Change in HgA1c lab values in the blood.

  12 months

Study Arms (2)

Tirzepatide

ACTIVE COMPARATOR

Tirzepatide 15mg Prefilled pen for weekly subcutaneous injection over 52 weeks

Drug: Tirzepatide

Placebo

PLACEBO COMPARATOR

Placebo Prefilled pen (volume matched) for weekly subcutaneous injection over 52 weeks

Drug: Placebo

Interventions

Tirzepatide DRUG

Tirzepatide 15mg Subcutaneous Solution

Also known as: Mounjaro

Tirzepatide

Placebo DRUG

Volume matched Subcutaneous Solution

Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female 40 years to 80 years of age at signing of informed consent
• Type 2 DM of minimum 5 years duration with HbA1c ≥7.0% to ≤10.5%
• Body mass index (BMI) ≥25 kilograms per meter squared (kg/m²)
• Presence of two discrete coronary artery plaques with visual diameter stenosis \>20% on CCTA
• At the baseline visit, participants must be on a stable (\>4 weeks) regiment of diabetes medications.
• Patients using oral hormonal contraceptives must switch to a non-oral contraceptive method, or add a barrier method of contraception for 4 weeks after initiation and for 4 weeks after each dose escalation

You may not qualify if:

• Have had a major cardiovascular event within the last 60 days
• Have type 1 diabetes mellitus
• Current use of GLP1-RA
• Have a history of severe hypoglycemia and/or hypoglycemia unawareness within the last 6 months
• Are currently planning treatment for diabetic retinopathy and/or macular edema
• Have history of, or currently planning a coronary, carotid, or peripheral artery revascularization (ie - stent, bypass)
• Have a history of pancreatitis
• Have a history of ketoacidosis or hyperosmolar state/coma
• Have a known clinically significant gastric emptying abnormality, have undergone or currently planning any gastric outlet obstruction, or have undergone or currently planning any gastric bypass (bariatric) surgery or restrictive bariatric surgery
• Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years
• Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
• Have had a blood transfusion or severe blood loss within 90 days prior to screening or have known hematological conditions that may interfere with HbA1c measurement
• Planned or Prior Bypass surgery
• Contradiction for CCTA (e.g. serious allergic reaction to the contrast dye) or CCTA not meeting entry standards after two attempts during the Baseline CCTA visit as assessed by the imaging core lab.
• Uncontrolled severe hypertension: systolic blood pressure \> 180 mmHg or diastolic BP \> 100 mm Hg prior to randomization (assessed at the screening visit) despite antihypertensive therapy

Sponsors & Collaborators

• Matthew J. Budoff: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center (The Lundquist Institute)

Torrance, California, 90502, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Atherosclerosis

Interventions

Tirzepatide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide

Study Officials

• Matthew A Budoff, MD

  The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sajad Hamal, MS

CONTACT

13109749336; shamal@lundquist.org

Ferdinand Flores, BS

CONTACT

13109749333; fflores@lundquist.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Double blind Placebo controlled

Study Record Dates

• First Submitted: January 12, 2023
• First Posted: February 1, 2023
• Study Start: January 2, 2024
• Primary Completion: December 1, 2025
• Study Completion: May 1, 2026
• Last Updated: October 15, 2024

Record last verified: 2024-10

Locations

US (1)