Overview

This trial is active, not recruiting.

Condition obesity
Treatments liraglutide, placebo
Phase phase 2
Sponsor Mayo Clinic
Start date December 2015
End date December 2016
Trial size 40 participants
Trial identifier NCT02647944, 15-001783

Summary

Obesity is associated with differences in stomach function, feeling of fullness after meals, and total calories consumed at a buffet meal. Based upon previous research, our study hypothesis is that weight loss with pharmacological agents may be individualized, based on the abnormality in those gastrointestinal functions. These studies will provide support for the principle that specific obesity medications should be selected according to individual characteristics, and it is anticipated that this approach will enhance efficacy of medication treatment of obesity.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model factorial assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Active Comparator)
Victoza initiated at 0.6mg S.C. daily for 1 week; subjects will return to the Clinical Research Unit (CRU) each week until an increase by 0.6 mg/day in weekly intervals to a dose of 3.0 mg/day is achieved. Once maintenance dose of 3.0 mg is achieved, subjects will return approximately every 4 weeks to obtain new supply of study medication.
liraglutide Victoza
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 Comparator)
Placebo initiated at 0.6mg S.C. daily for 1 week; subjects will return to the Clinical Research Unit (CRU) each week until an increase by 0.6 mg/day in weekly intervals to a dose of 3.0 mg/day is achieved. Once maintenance dose of 3.0 mg is achieved, subjects will return approximately every 4 weeks to obtain new supply of study medication.
placebo

Primary Outcomes

Measure
Change in body weight
time frame: Baseline, 16 weeks

Secondary Outcomes

Measure
Change in gastric half-emptying time
time frame: Baseline, approximately 16 weeks
Change in peak post prandial level of peptide tyrosine tyrosine ( PYY)
time frame: Baseline, approximately 16 weeks
Change in peak post prandial level of Glucagon-like peptide-1 receptor agonists (GLP-1)
time frame: Baseline, approximately 16 weeks
Change in proportion of stomach contents emptied at 2 hours
time frame: Baseline, approximately 16 weeks
Change in proportion of stomach contents emptied at 4 hours
time frame: Baseline, approximately 16 weeks
Change in gastric volume
time frame: Baseline, approximately 16 weeks
Change in satiation
time frame: Baseline, approximately 16 weeks
Change in satiety
time frame: Baseline, approximately 16 weeks

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - Overweight and obese adults (≥30 kg/m2 or ≥27 kg/m2 with an obesity-related co-morbidity). - Subjects will reside 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 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.

Additional Information

Official title Pilot Study of the Effect of Liraglutide on Weight Loss and Gastric Functions in Obesity
Principal investigator Michael Camilleri, MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Mayo Clinic.