Effect Of Semaglutide In Coronary Atheroma Plaque

NCT05071417 | Unknown Phase 3

• 1 other identifier: SEPLA
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

The main objective of this trial is to evaluate the effect of Semaglutide on the burden of coronary atherosclerosis, based on the change in Percent Atheroma Volume (PAV) by quantifying atheroma plaque throughout the coronary tree based on the analysis of CCTA in asymptomatic subjects with T2D in optimized and stable treatment with Semaglutide.

Conditions

Atheroscleroses, Coronary

Outcome Measures

Primary Outcomes (1)

• Plaque burden modification assessed by coronary CT and plaque quantification

  The main objective of this trial is to evaluate the effect of Semaglutide on the burden of coronary atherosclerosis, based on the change in Percent Atheroma Volume (PAV) by quantifying atheroma plaque throughout the coronary tree based on the analysis of CCTA in asymptomatic subjects with T2D in optimized and stable treatment with Semaglutide

  18 months

Secondary Outcomes (5)

• Atheroma volume modification assessed by coronary CT and plaque quantification

  18 months

• Percentage of patients with significant plaque regresion assessed by coronary CT

  10 months

• Changes in composition of artery wall assessed by coronary CT and plaque quantification

  18 months

• Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)

  18 months

• Incidence of cardiovascular events

  18 months

Study Arms (1)

Semaglutide

EXPERIMENTAL

Patients on semaglutide

Drug: Semaglutide

Interventions

Semaglutide DRUG

Usual treatment with semaglutide. Dose 0.5 - 1mg weekly, subcutaneous, weekly

Semaglutide

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women ≥35 and ≤ 65 years
• Absence of previous history of clinical cardiovascular events
• Subjects already taking therapy for diabetes on stable doses for 3 months or more.
• Subjects must have HbA1c at the initial screening visit between 8 and 10%
• Coronary CT performed less than 3 months before starting study medication

You may not qualify if:

• Clinically significant heart disease
• New York Heart Association (NYHA) class \>II
• Known stroke or transient ischemic accident
• Uncontrolled hypertension at randomization, defined as a resting systolic blood pressure of 180 mm Hg at rest
• Personal or family history of hereditary muscular disorders
• Fasting triglyceride level \> 250 mg/dL at screening
• Type 1 diabetes
• Known thyroid disease or subject taking thyroid replacement therapy
• Estimated glomerular filtration rate \< 60 ml/min/1.73m2
• History of malignancy
• Known major active infection, or major hematologic, renal, metabolic, gastrointestinal or endocrine dysfunction
• Baseline coronary CT does not meet Core Lab technical standards
• Cardiac rhythm different to normal sinus rhythm.
• Female subjects cannot be pregnant or breastfeeding, planning to become pregnant or planning to breastfeed during the entire study
• Premenopausal females of childbearing potential must be willing to use an acceptable method(s) of birth control during treatment and for an additional 15 weeks after the end of treatment

Sponsors & Collaborators

• Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León: lead

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Leopoldo Pérez de Isla

  Hospital Clínico San Carlos. Madrid. Spain.

  STUDY DIRECTOR

Central Study Contacts

Leopoldo Pérez de Isla, MD

CONTACT

+34609084225; leopisla@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Phase IV low-intervention, double-blind, multicenter clinical trial to evaluate the effects of 18 months of semaglutide treatment on the volume, architecture, and composition of coronary atheroma plaques in subjects with DM2 for at least 10 years and without clinical cardiovascular disease. Patients with DM2 will be included if their previously prescribed treatment was insufficient to achieve adequate control of glycemic and glycosylated hemoglobin levels (HBA1c) to reach their therapeutic objective and the researcher has considered semaglutide treatment to be appropriate according to its clinical criteria and based on the indication of this treatment in this patient profile. The study treatment will therefore be the same treatment that the patient would receive even if they did not participate in the study; this condition is the basic norm for the inclusion of the patient in the study.

Study Record Dates

• First Submitted: August 5, 2021
• First Posted: October 8, 2021
• Study Start: November 1, 2021
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2025
• Last Updated: October 8, 2021

Record last verified: 2021-09