Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-24 @ 5:08 PM
NCT ID:
NCT02718950
Eligibility 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02718950
Study Brief:
Protocol Section:
NCT02718950