NCT03038620 trial results

Inclusion Criteria: * Age ≥ 35 years * Able to provide informed consent * BMI ≥ 30 kg/m2 or ≥ 27 kg/m2 with metabolic syndrome * Metabolic syndrome is defined as at least three of the following:3 1. waist circumference \> 102 cm (40 in) in men and 88 cm (35 in) in women 2. triglycerides \> 150 mg/dL or on treatment for hypertriglyceridemia 3. HDL cholesterol \< 40 mg/dL in men and \< 50 mg/dL in women 4. blood pressure \> 130/85 mmHg or on treatment for hypertension 5. fasting glucose \> 100 mg/dL Exclusion Criteria: * Treatment with Glucagon-like peptide-1 (GLP-1) receptor agonists (including liraglutide, exenatide or others as they become available), dipeptidyl peptidase 4 (DPP-4) inhibitors or insulin within the last 3 months. * Receipt of any anti-obesity drug or supplement within 1 month prior to screening for this trial. * Self-reported or clinically documented history of significant fluctuations (\>5% change) in weight within 3 months prior to screening for this trial. * History of diabetes mellitus (type 1 or 2) or on treatment with anti-diabetes medication. * History of chronic pancreatitis or idiopathic acute pancreatitis (current or prior history). * History of gallbladder disease (cholelithiasis or cholecystitis). * Chronic kidney disease stage III or greater (eGFR\<60 mL/min). * Obesity induced by other endocrinologic disorders (e.g. Cushing Syndrome). * Current or history of treatment with medications that may cause significant weight gain, within 1 month prior to screening for this trial, including systemic corticosteroids (except for a short course of treatment, i.e., 7- 10 days), tri-cyclic antidepressants, atypical antipsychotic and mood stabilizers (e.g., imipramine, amitryptiline, mirtazapine, paroxetine, phenelzine, chlorpromazine, thioridazine, clozapine, olanzapine, valproic acid and its derivatives, and lithium). * Diet attempts using herbal supplements or over-the-counter medications within 1 month prior to screening for this trial. * Current participation in an organized weight reduction program or within the last 1 month prior to screening for this trial. * Participation in a clinical trial within the last 3 months prior to screening for this trial. * Familial or personal history of multiple endocrine neoplasia type 2 or familial medullary thyroid carcinoma. * Personal history of non-familial medullary thyroid carcinoma. * History of Major Depressive Disorder within the last 2 years. * History of other severe psychiatric disorders, e.g., schizophrenia, bipolar disorder. * Any lifetime history of a suicide attempt. * A history of any suicidal behavior in the last month prior to randomization. * Surgery scheduled for the trial duration period, except for minor surgical procedures, at the discretion of the Investigator. * Known or suspected hypersensitivity to trial product(s) or related product(s). * Known or suspected abuse of alcohol or narcotics. * Language barrier, mental incapacity, unwillingness or...