Pilot Study of the Effect of Liraglutide 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.
Intervention MeSH terms: Liraglutide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study was 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.

          -  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.