Pilot Study of the Effect of Liraglutide 3.0 mg on Weight Loss and Gastric Functions in Obesity

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.