Pilot Study of the Effect of Liraglutide 3.0 mg on Weight Loss and Gastric Functions in Obesity
Condition: Obesity
MeSH terms: Obesity; Weight Loss
Intervention: Liraglutide; Placebo
Intervention description: Initiate at 0.6mg S.C. daily for 1 week; subjects will return to the Clinical Research Unit (CRU) each week until an increase by 0.6mg/day in weekly intervals to a dose of 3.0 mg/day is achieved (~4 weeks). Once maintenance dose of 3.0 mg is achieved, subjects will return approximately every 4 weeks to obtain new supply of study medication.; Placebo administration will match the study drug.
Intervention MeSH terms: Liraglutide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Enrollment: 136.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      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.
    

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.

          -  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.