Intervention: Victoza
Trial phase: Phase 4
ATC code: A10BJ02
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Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 92
Group description: Drug: Liraglutide Active Drug

Other Names:

Saxenda

Escalate the liraglutide (active) dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day through subcutaneous injection.

Liraglutide: Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.
Eligibility criteria:
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

waist circumference > 102 cm (40 in) in men and 88 cm (35 in) in women
triglycerides > 150 mg/dL or on treatment for hypertriglyceridemia
HDL cholesterol < 40 mg/dL in men and < 50 mg/dL in women
blood pressure > 130/85 mmHg or on treatment for hypertension
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 inability to understand.
Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods. These include abstinence and the following methods: diaphragm with spermicide, condom with spermicide (by male partner), intrauterine device, sponge, spermicide, Norplant®, Depo-Provera® or oral contraceptives.