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:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-25 @ 4:06 AM
NCT ID:
NCT03038620
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
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 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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
35 Years
Study:
NCT03038620
Study Brief:
Protocol Section:
NCT03038620