Influence of Liraglutide, a GLP-1 Receptor Agonist, on Brown Adipose Tissue (BAT) Activity in Humans

• Status: Unknown status
• Trial end date: 2017-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to access liraglutide influence brown adipose tissue recruitment and its thermogenic effect through hypothalamic activation in obese individuals.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Campinas, Brazil
• Treatments: Liraglutide

Criteria

Inclusion Criteria:

• Body mass index over 30 kg/m2.

Exclusion Criteria:

• Hypersensitivity to liraglutide or any of its vehicle components;

• History of diabetes or pre-diabetes - either by fasting glycemia, oGTT or HbA1c;

• Previous treatment within the last 3 months with glucagon like peptide-1 agonists, iDPP4 or any medication that is associated with BAT activation, including propranolol and benzodiazepines;

• Liver diseases, except non-alcoholic steatohepatitis (NASH);

• Infection by HIV, hepatitis B or hepatitis C;

• Addiction to cannabis, heroin, morphine, cocaine, benzodiazepines or amphetamine;

• Obesity induced by other disorders such as Cushing syndrome, hypothyroidism, lipodystrophy

• Current or history of treatment with medications that may cause significant weight gain within 3 months prior to screening, including systemic corticosteroids (except for a short course of treatment, i.e. 7-10 days), tricyclic antidepressants, atypical antipsychotic and mood stabilizers (e.g. imipramine, amitriptyline, mirtazapine, paroxetine, phenelzine, chlorpromazine, thioridazine, clozapine, olanzapine, valproic acid and its derivatives, and lithium);

• Current participation (or within the last 3 months) in an organized weight reduction program

• Currently or previous using within 3 months before screening of pramlintide, sibutramine, orlistat, topiramate, or metformin (either by prescription or as part of a clinical trial)

• Participation in a clinical trial within the last 3 months prior to screening

• Simultaneous participation in any other clinical trial of an investigational drug

• Previous surgical treatment of obesity;

• Cancer (past or present, except basal cell skin cancer or squamous cell skin cancer), which in the investigator's opinion could interfere with the results of the trial

• Liver enzyme (ALT and AST) above 2.5 x of reference range

• Pancreatic enzymes (amylase, lipase) above 3 x the reference range

• Chronic kidney disease stages 3, 4, or 5

• Relevant inflammatory or acute or chronic infectious disease; hyperthyroidism; neurological, psychiatric, gastrointestinal, respiratory, renal, hepatic or cardiac relevant disease, that could interfere with trial results per the judgment of investigator

• Any condition that at the discretion of investigator could interfere with treatment adhesion on patient safety

• Blood donation or transfusion within the last 3 months

• Pregnancy or intention of pregnancy

• History of Multiple Endocrine Neoplasia Syndrome Type 2 (MEN 2)

• History of pancreatitis

• Less than 80% of liraglutide adherence

• Calcitonin above the reference range at the screening visit.