Antigen-Lipid-Driven Monoclonal Gammopathies Targeting Epicardial Fat

• Status: Withdrawn
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this research study is to learn about the effect of Liraglutide (Victoza) on the fat of the heart and some fat cells in blood.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Miami
• Treatments: Glucagon-Like Peptide 1; Liraglutide

Criteria

Inclusion Criteria:

• BMI ≥27 kg/m2

• At least one overweight/obesity related comorbidity (such as type 2 diabetes, pre-diabetes [IFG, IGT], hypertension, dyslipidemia)

• Age > 18 and < 70 years old

Exclusion Criteria:

• Known contra-indications to Liraglutide, such as previous history of pancreatitis or medullary thyroid carcinoma, personal or family history of MEN, in accordance with risks and safety information included in the latest updated Prescribing Information for Victoza®

• Type 1 diabetes, as defined by American Diabetes Association (ADA) criteria

• Insulin dependent or treated type 2 diabetes

• Current use of other injectable incretins

• History of diabetes ketoacidosis

• Advanced Chronic Kidney Disease, as defined by Glomerular Filtration Rate (GFR) < 30 mL/min/1.73m2

• Clinical signs or symptoms of New York Heart Association (NYHA) class III-IV heart failure

• Clinical or laboratory evidences of chronic active liver diseases

• Acute or chronic infective diseases

• Known or suspected allergy to Liraglutide, excipients, or related products

• Pregnant, breast-feeding or the intention of becoming pregnant

• Females of childbearing potential who are not using adequate contraceptive methods