Pilot Study of the Effect of Liraglutide 3.0 mg on Weight Loss and Gastric Functions in Obesity
Pilot Study of the Effect of Liraglutide 3.0 mg on Weight Loss and Gastric Functions in Obesity
This study is being done to assess the stomach emptying effect of a maximum dose of 3 mg
 Liraglutide compared to placebo in subjects who are overweight or obese. Liraglutide is a
 medication approved by the Food and Drug Administration (FDA) for routine clinical use.
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.

 -  The investigators plan to recruit equal proportions of men and women.

 -  Women of childbearing potential will be using an effective form of contraception, and
 have negative pregnancy tests within 48 hours of enrollment and before each radiation
 exposure. In addition, since liraglutide 3.0 mg is classified as Pregnancy Category X,
 monthly urine pregnancy testing will be performed in any female participant with
 childbearing potential.

 -  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, cholecystectomy, 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 past or current history of pancreatitis, gallstones, history of
 alcoholism, blood triglyceride levels >500 mg/dL.

 -  Significant untreated psychiatric dysfunction based upon screening with the Hospital
 Anxiety and Depression Inventory (HAD), 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 HAD score >11 on either the
 Anxiety or Depression subscales, 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 any medication (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.

 -  Delayed gastric emptying at 2 and 4 hours

 -  Hypersensitivity to the study medication, liraglutide

 -  Participate in highly intense physical activity program that could potentially
 interfere with study interpretation.