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Semaglutide Treatment On Coronary Progression | Clinical Trials | Clareo Health

COMPLETEDPHASE4

Semaglutide Treatment On Coronary Progression

Effect of Semaglutide on Coronary Atherosclerosis Plaque Progression in Type 2 Diabetics

NCT03985384•Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Summary

The purpose of this research study is to see the effect of the diabetes medicine Semaglutide on a condition called atherosclerosis. Atherosclerosis is a narrowing, blockage, or hardening of the arteries due to a build up of calcium. This study will look specifically at the arteries involving the heart.

Detailed Description

To determine the effects of semaglutide therapy on the morphology and composition of non-calcified coronary atherosclerotic plaque (NCP), including the progression of plaque volume.

Eligibility

Age

40 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Men or women with type 2 diabetes with a glycated hemoglobin level of 7.0% or more, drug naïve, or treated with oral agents and/or basal insulin. For patients on basal insulin at entry, the PI will consider dose reduction of basal insulin according to A1c and risk for hypoglycemia. Patients on SGLT-2 inhibitors may be screened but the agents must be discontinued at least 30 days prior to randomization.
•Age \> 40 years of age at the time of the initial Screening visit (V1) with a diagnosis of T2DM in accordance with American Diabetes Association (ADA) guidelines and with at least one cardiovascular risk factor (hypertension, high cholesterol, family history of premature heart disease or past/current smoking) or prior ASCVD (prior stroke, TIA, claudication, coronary artery disease)
•Willingness to participate in the study and ability to sign informed consent
•In the investigator's opinion subjects are willing and likely able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures whether or not they receive investigational product for the duration of the trial.

Exclusion Criteria

•History of type 1 diabetes mellitus or a history of ketoacidosis.
•Current use of GLP-1-receptor agonists or use of a GLP-1 receptor agonist within 3 mos. of screening.
•Current Use of SGLT-2 inhibitors within 30 days of screening
•Subjects on prandial insulin or using an insulin pump or pramlintide.
•Any clinically significant malabsorption condition.
•History of one or more severe hypoglycemic episodes within 6 months of Screening (V1) or a severe hypoglycemic episode occurring during the interval between the Screening visit (V1) and randomization.
•Subjects experiencing a cardiovascular event (e.g., myocardial infarction or stroke) or undergoing coronary angioplasty or peripheral intervention procedure between the Screening visit (V1) and randomization.
•Recent ASCVD Event (stroke, heart attack, ACS or revascularization) within 3 months (90 days) of the screening visit (VI).
•Subjects undergoing any cardiovascular surgery (e.g., valvular surgery) within 3 months (90 days) of the Screening visit (V1).
•Subjects with any planned coronary revascularization or peripheral intervention procedure or other cardiovascular surgery.
+17 more criteria

Locations (1)

Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center

Torrance, California, United States

Key Dates

Start Date

April 30, 2019

Primary Completion Date

December 27, 2022

Completion Date

December 27, 2022

Last Updated

October 5, 2023

Enrollment

140

ACTUAL participants

Conditions

Type 2 DiabetesCoronary Artery Disease

Interventions

Semaglutide 2 MG/1.5 ML Subcutaneous Solution

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 5, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Semaglutide Treatment On Coronary Progression

Inclusion Criteria

Exclusion Criteria

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