Antigen-Lipid-Driven Monoclonal Gammopathies Targeting Epicardial Fat

NCT02920190 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 20160568
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Monoclonal Gammopathies; Overweight; Obesity

Outcome Measures

Primary Outcomes (1)

• Change in Epicardial Fat Thickness

  Epicardial fat thickness measured in mm via ultrasound

  Baseline, 12 months

Secondary Outcomes (2)

• Change in serum immunoglobulins

  Baseline, 12 months

• Change in plasma ceramide levels

  Baseline, 12 months

Study Arms (1)

Liraglutide Group

EXPERIMENTAL

Participants in this group will receive the Liraglutide intervention for 12 months

Drug: Liraglutide

Interventions

Liraglutide DRUG

1.8 mg Liraglutide administered subcutaneously once daily for 12 consecutive months

Also known as: Victoza

Liraglutide Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead

MeSH Terms

Conditions

Paraproteinemias; Overweight; Obesity

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• James Hoffman, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 22, 2016
• First Posted: September 30, 2016
• Study Start: September 1, 2020
• Primary Completion: September 1, 2021
• Study Completion: December 31, 2021
• Last Updated: September 21, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share