Antigen-Lipid-Driven Monoclonal Gammopathies Targeting Epicardial Fat

Reduction of Antigen-Lipid-Driven Monoclonal Gammopathies by Targeting Epicardial Fat and Its Lipids Content With Liraglutide: A Glucagon Like Peptide-1 Receptor Analogue (GLP-1RA)

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02920190

Enrollment

Registered

2016-09-30

Start date

2020-09-01

Completion date

2021-12-31

Last updated

2020-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Monoclonal Gammopathies, Obesity, Overweight

Brief 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.

Interventions

DRUGLiraglutide

1.8 mg Liraglutide administered subcutaneously once daily for 12 consecutive months

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change in Epicardial Fat Thickness	Baseline, 12 months	Epicardial fat thickness measured in mm via ultrasound

Secondary

Measure	Time frame	Description
Change in serum immunoglobulins	Baseline, 12 months	Immunoglobin levels assessed in g/L will be evaluated using serum blood samples
Change in plasma ceramide levels	Baseline, 12 months	Plasma ceramide levels will be evaluated in umol/L

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026