Overview

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

Status:
Completed
Trial end date:
2016-12-30
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Mayo Clinic
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Novo Nordisk A/S
Treatments:
Liraglutide
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.