Primary outcomeMedian· 5 weeks
Gastric Emptying of Solids Half-time (T1/2) at 5 Weeks
| Group | Value (minutes) |
|---|---|
| Liraglutide | 180 |
| Placebo | 117 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataPilot Study of the Effect of Liraglutide on Weight Loss and Gastric Functions in Obesity
NCTNCT02647944 (opens ClinicalTrials.gov in a new tab)Other id15-001783Other idR56DK067071Other idUL1TR000135
Overview
- Status
- Completed
- Phase
- Phase 2
- Enrollment
- 40 participants (actual)
- Sponsor
- Mayo Clinic · Other
- Design
- Randomized · Double masking
- Countries
1 country
United States
- Start
- 18 Dec 2015
- Primary completion
- 30 Dec 2016
- Completion
- 30 Dec 2016
- First posted
- 6 Jan 2016 (estimated)
- Last update posted
- 27 Oct 2017
- Conditions
- Obesity
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
201520162017
- Ph 2
Pilot Study of the Effect of Liraglutide on Weight Loss and Gastric Functions in Obesity
NCT0264794418 Dec 2015 to 30 Dec 2016
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- LiraglutideDrug
- PlaceboDrug
Arms2
Active comparator
Liraglutide
Saxenda 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 comparator
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.
Primary outcomes2
Outcomes the sponsor listed as primary.
Gastric Emptying of Solids Half-time (T1/2) at 5 Weeks
Time frame · 5 weeks
Registry description
Gastric emptying of solids was assessed by scintigraphy using a 320 Kcal 99mTc-radiolabeled egg, solid-liquid meal. Gastric Emptying Half-time was the linear interpretation of time to when 50% of radiolabeled meal emptied from the stomach.
Gastric Emptying of Solids Half-time (T1/2) at 16 Weeks
Time frame · 16 weeks
Registry description
Gastric emptying of solids was assessed by scintigraphy using a 320 Kcal 99mTc-radiolabeled egg, solid-liquid meal. Gastric Emptying Half-time was the linear interpretation of time to when 50% of radiolabeled meal emptied from the stomach.
Secondary outcomes(8)
Weight Change at 5 Weeks
Time frame · baseline, 5 weeks
Registry description
Body weight in kg was measured at 5 weeks and compared to baseline.
Weight Change at 16 Weeks
Time frame · baseline, 16 weeks
Registry description
Body weight in kg was measured at 16 weeks and compared to baseline.
Satiety by Buffet Meal, Total Calories Ingested at 16 Weeks
Time frame · 16 weeks
Registry description
Satiety (a measure of appetite) was appraised by "free feeding" buffet meal consisting of standard foods of known nutrient composition. The total amount of food consumed was analyzed by the study dietitian.
Satiation Volume to Fullness at 16 Weeks
Time frame · 16 weeks
Registry description
After drinking Ensure, participants recorded their sensations every 5 minutes using a numerical scale from 0 to 5, with level 0 being no symptoms, level 3 corresponding to fullness sensation after a typical meal and level 5 corresponding to the maximal tolerated volume (maximum or unbearable fullness/satiation).
Satiation Maximum Tolerated Volume at 16 Weeks
Time frame · 16 weeks
Registry description
After drinking Ensure, participants recorded their sensations every 5 minutes using a numerical scale from 0 to 5, with level 0 being no symptoms, level 3 corresponding to fullness sensation after a typical meal and level 5 corresponding to the maximal tolerated volume (maximum or unbearable fullness/satiation).
Gastric Fasting Volume at 16 Weeks
Time frame · 16 weeks
Registry description
Gastric fasting volume was measured by single photon emission computed tomography (SPECT) imaging of the stomach after intravenous injection of 99mTC-pertechnetate, which is taken up by the gastric mucosa.
Gastric Postprandial Volume at 16 Weeks
Time frame · 16 weeks
Registry description
Gastric fasting volume was measured by single photon emission computed tomography (SPECT) imaging of the stomach after intravenous injection of 99mTC-pertechnetate, which is taken up by the gastric mucosa.
Gastric Accommodation Volume at 16 Weeks
Time frame · 16 weeks (approximately 1 hour after 99mTC injection)
Registry description
Change between postprandial and fasting whole gastric volume by 99mTc-SPECT Imaging. A noninvasive SPECT method was used to measure gastric volume during fasting and 32 min after a liquid nutritional supplement meal. Subjects reported to the clinic after an overnight fast. 99mTC was given by an intravenous injection in the forearm. The first fasting scan was obtained, and the study medication was given s.c. After 10 min, a 2nd fasting post medication scan was obtained, and the meal consumed; then two serial postprandial scans were obtained. Each scan required 9-12 min. Tomographic images of the gastric wall were obtained throughout the long axis of the stomach using a dual-head gamma camera that rotates around the body. This allows assessment of the radiolabeled circumference of the gastric wall, rather than the intragastric content.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Primary outcomeMedian· 16 weeks
Gastric Emptying of Solids Half-time (T1/2) at 16 Weeks
| Group | Value (minutes) |
|---|---|
| Liraglutide | 142 |
| Placebo | 113 |
Secondary and other outcome results(6)
Secondary outcomeMedian· baseline, 5 weeks
Weight Change at 5 Weeks
| Group | Value (kg) |
|---|---|
| Liraglutide | 3.70 |
| Placebo | 0.60 |
Secondary outcomeMedian· baseline, 16 weeks
Weight Change at 16 Weeks
| Group | Value (kg) |
|---|---|
| Liraglutide | 5.30 |
| Placebo | 2.5 |
Secondary outcomeMedian· 16 weeks
Satiety by Buffet Meal, Total Calories Ingested at 16 Weeks
| Group | Value (kcal) |
|---|---|
| Liraglutide | 554.0 |
| Placebo | 680.5 |
Secondary outcomeMedian· 16 weeks
Satiation Volume to Fullness at 16 Weeks
| Group | Value (mL) |
|---|---|
| Liraglutide | 360 |
| Placebo | 600 |
Secondary outcomeMedian· 16 weeks
Satiation Maximum Tolerated Volume at 16 Weeks
| Group | Value (mL) |
|---|---|
| Liraglutide | 750 |
| Placebo | 1126 |
Secondary outcomeMedian· 16 weeks
Gastric Fasting Volume at 16 Weeks
| Group | Value (mL) |
|---|---|
| Liraglutide | 231 |
| Placebo | 192 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| LiraglutideSaxenda 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. | 0 / 19 | 0 / 19 | 17 / 19 |
| PlaceboPlacebo 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. | 0 / 21 | 0 / 21 | 14 / 21 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies4
Studies that cite this trial.
Studies with results
4 studies on this page
Indexing hint: Randomized controlled trial · 2026
8 results
Appetite Suppression by GLP-1 Receptor Agonists: Role of Delayed Gastric Emptying.
Friedman et al. 2026Obesity (Silver Spring, Md.)
PMID 42392577PMC13422674DOI 10.1002/oby.70255PUB-42392577
CC BY8 results
Indexing hint: Randomized controlled trial · 2022
7 results
Effects of liraglutide on gastrointestinal functions and weight in obesity: A randomized clinical and pharmacogenomic trial.
Maselli et al. 2022Obesity (Silver Spring, Md.)cited by 111
PMID 35894080PMC9335902DOI 10.1002/oby.23481PUB-35894080
Rights unknown7 results
Indexing hint: Randomized controlled trial · 2020
14 results
GLP-1 Analog Modulates Appetite, Taste Preference, Gut Hormones, and Regional Body Fat Stores in Adults with Obesity.
Kadouh et al. 2020The Journal of clinical endocrinology and metabolismcited by 125
PMID 31665455PMC7105351DOI 10.1210/clinem/dgz140PUB-31665455
Rights unknown14 results
Indexing hint: Randomized controlled trial · 2017
11 results
Effects of liraglutide on weight, satiation, and gastric functions in obesity: a randomised, placebo-controlled pilot trial.
Halawi et al. 2017The lancet. Gastroenterology & hepatologycited by 180
PMID 28958851DOI 10.1016/s2468-1253(17)30285-6PUB-28958851
Full text at the publisher11 results
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 65 Years
- Healthy volunteers
- Accepted
Inclusion and exclusion criteria, as posted
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.
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