Semaglutide Treatment On Coronary Progression

NCT03985384 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: 22174-01
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes; Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Rate of change in non-calcified plaque volume

  Rate of change in non-calcified plaque volume

  12 months

Secondary Outcomes (1)

• Rate of change in total plaque volume

  12 months

Study Arms (2)

Semaglutide

ACTIVE COMPARATOR

Semaglutide 2mg/1.5 ml (1.34 mg/ml) Prefilled pen for SQ injection

Drug: Semaglutide 2 MG/1.5 ML Subcutaneous Solution

Placebo

PLACEBO COMPARATOR

Placebo 1.5 ml, pen-injector for SC injection.

Drug: Placebo

Interventions

Semaglutide 2 MG/1.5 ML Subcutaneous Solution DRUG

Semaglutide 2 MG/1.5 ML Subcutaneous Solution

Semaglutide

Placebo DRUG

Placebo 1.5 ml, pen-injector for SC injection.

Placebo

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Subjects with New York Heart Association (NYHA) Class III or IV heart failure at the Screening visit (V1).
• Renal insufficiency (calculated creatinine clearance of \<50 ml per minute, MDRD equation).
• AST or ALT \>2 X the upper limit of normal (ULN) at the Screening visit (V1), or a total bilirubin \>1.5 X the ULN unless the subject has a history of Gilbert's.
• Weight in excess of 325 pounds
• Resting hypotension (systolic blood pressure of \<90mmHg) or resting hypertension (systolic blood pressure of \>170mmHg or diastolic blood pressure of \>110 mmHg) or the treating physician is allowed to adjust background blood pressure medication(s) to lower blood pressure values in order for the subject to be re-assessed for enrollment eligibility.

Sponsors & Collaborators

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

Study Sites (1)

Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center

Torrance, California, 90502, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Coronary Artery Disease

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Matthew Budoff, MD

  Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Double Blind Placebo Controlled

Study Record Dates

• First Submitted: June 10, 2019
• First Posted: June 13, 2019
• Study Start: April 30, 2019
• Primary Completion: December 27, 2022
• Study Completion: December 27, 2022
• Last Updated: October 5, 2023

Record last verified: 2023-10

Locations

US (1)