- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03523273
Pilot Study of the Effect of Liraglutide 3.0 mg on Weight Loss and Gastric Functions in Obesity
May 27, 2022 updated by: Michael Camilleri, MD
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
136
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Liraglutide
Liraglutide 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.
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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.
Other Names:
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Experimental: Placebo
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.
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Placebo administration will match the study drug.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gastric Emptying of Solids (T1/2)
Time Frame: 5 weeks
|
The time for half of the ingested solids to leave the stomach.
Following a meal consisting of two eggs labeled with technetium Tc 99m sulfur colloid (1 mCi), gastric emptying of solids was assessed with scintigraphy imaging.
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5 weeks
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Gastric Emptying of Solids (T1/2)
Time Frame: 16 weeks
|
The time for half of the ingested solids to leave the stomach.
Following a meal consisting of two eggs labeled with technetium Tc 99m sulfur colloid (1 mCi), gastric emptying of solids was assessed with scintigraphy imaging.
|
16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Weight at 5 Weeks
Time Frame: baseline, 5 weeks
|
Change in subject's weight, in kilograms
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baseline, 5 weeks
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Change in Weight at 16 Weeks
Time Frame: baseline, 16 weeks
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Change in subject's weight, in kilograms
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baseline, 16 weeks
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Satiety
Time Frame: 16 weeks
|
Subjects self-reported fullness after eating as much of a prescribed meal measured by kilocalories of food consumed.
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16 weeks
|
Satiation Volume to Fullness
Time Frame: 16 weeks
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Subjects ingest Ensure 300mL drink meal at a constant rate of 30mL/min until self-reported fullness and volume consumed will be measured in milliliters (mL).
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16 weeks
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Maximum Satiation
Time Frame: 16 weeks
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Subjects ingest Ensure 300mL drink meal at a constant rate of 30mL/min until they reach maximum or unbearable fullness.
Volume consumed will be measured in milliliters (mL).
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16 weeks
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Fasting Gastric Volume Prior to Meal
Time Frame: 16 weeks
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Gastric fasting volume was measured prior to a meal of 300 mL Ensure drink using noninvasive single photon emission-computed tomography (SPECT) of the stomach.
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16 weeks
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Gastric Volume After Meal
Time Frame: 16 weeks
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Gastric volume was measured after a meal of 300 mL Ensure drink using noninvasive single photon emission-computed tomography (SPECT) of the stomach.
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16 weeks
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Gastric Accommodation
Time Frame: 16 weeks
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Measured in milliliters (mL), using the difference between the fasting gastric volume prior to the meal and the gastric volume after the meal.
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16 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 29, 2017
Primary Completion (Actual)
August 31, 2021
Study Completion (Actual)
August 31, 2021
Study Registration Dates
First Submitted
May 1, 2018
First Submitted That Met QC Criteria
May 1, 2018
First Posted (Actual)
May 14, 2018
Study Record Updates
Last Update Posted (Actual)
June 23, 2022
Last Update Submitted That Met QC Criteria
May 27, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-001783 Part B
- UL1TR000135 (U.S. NIH Grant/Contract)
- R56DK067071 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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