Clinical trial NCT02647944 (phase 2, status: completed)
Conditions: obesity
ICD codes: E66.8, E66.9, E66.1, O99.214, O99.215, O99.210, O99.211
Drugs: liraglutide, placebo
SMILES: CN(C)C(=N)NC(N)=N, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          -  Overweight and obese adults (≥30 kg/m^2 or ≥27 kg/m^2 with an obesity-related
             co-morbidity).

          -  Subjects residing within 125 miles of Mayo Clinic in Rochester, Minnesota.

          -  Healthy individuals with no unstable psychiatric disease and not currently on
             treatment for cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological,
             neurological, or endocrine (other than hyperglycemia type 2 diabetes mellitus on
             metformin) disorders.

          -  Women of childbearing potential will be using an effective form of contraception, and
             have negative pregnancy tests within 48 hours of enrolment and before each radiation
             exposure.

          -  Subjects must have the ability to provide informed consent before any trial-related
             activities.

        Exclusion criteria:

          -  Weight exceeding 137 kilograms (safety limit of camera for measuring gastric volumes).

          -  Abdominal surgery other than appendectomy, Caesarian section or tubal ligation.

          -  Positive history of chronic gastrointestinal diseases, systemic disease that could
             affect gastrointestinal motility, or use of medications that may alter
             gastrointestinal motility, appetite or absorption, e.g., orlistat.

          -  Patients with a personal or family history of medullary thyroid carcinoma or Multiple
             Endocrine Neoplasia-type 2.

          -  Patients with a personal history of pancreatitis (acute or chronic)

          -  Significant untreated psychiatric dysfunction based upon screening with the Hospital
             Anxiety and Depression Inventory, a self-administered alcoholism screening test
             (AUDIT-C), and the Questionnaire on Eating and Weight Patterns (binge eating disorders
             and bulimia). If such a dysfunction is identified by a Hospital Anxiety Depression
             (HAD) score >8 or difficulties with substance or eating disorders, the participant
             will be excluded and given a referral letter to his/her primary care doctor for
             further appraisal and follow-up.

          -  Intake of medication, whether prescribed or over the counter (except multivitamins),
             within 7 days of the study. Exceptions are birth control pill, estrogen replacement
             therapy, thyroxin replacement therapy and any medication administered for
             co-morbidities as long as they do not alter gastrointestinal motility including
             gastric emptying (GE) and gastric accommodation. For example, statins for
             hyperlipidemia, diuretics, β-adrenergic blockers,Angiotensin Converting Enzyme (ACE)
             inhibitors and angiotensin antagonists for hypertension, and metformin for type 2
             diabetes mellitus or prediabetes are permissible. In contrast, resin sequestrants for
             hyperlipidemia [which may reduce GE and reduce appetite, α2-adrenergic agonists for
             hypertension, or other glucagon-like peptide-1 receptor agonists (GLP-1) receptor
             agonists (exenatide) or amylin analogs (pramlintide) are not permissible because they
             significantly affect GE and/or gastric accommodation.

          -  Hypersensitivity to the study medication, liraglutide.