A Phase 2 interventional study of Liraglutide and Placebo in Obesity, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-27.
Sponsored by Mayo Clinic · Phase 2, Interventional, and Treatment
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.
The objective of this study was to compare effects of liraglutide and placebo over 16 weeks on gastric motor functions, satiation, satiety and weight in obese patients. Subjects were randomized to liraglutide or placebo. Liraglutide or placebo was escalated by 0.6mg/day each week for 5 weeks and continued until week 16. At baseline and after 16 weeks' treatment, the investigators measured weight, gastric emptying of solids (GES), gastric volumes, satiation (maximum tolerated volume of liquid nutrient drink), and satiety. GES was also measured at 5 weeks.
During the study, the subjects received standardized dietetic and behavioral advice for weight reduction therapy. All subjects were given a standard text for information and met with a behavioral psychologist who has expertise in obesity treatment at the baseline visit and at visits at weeks 4,8, and 12. Additionally, the subjects had brief contact with a member of the study team every 4 weeks to inquire about their adherence to study protocol, any difficulties they were experiencing, whether they were reading their text assignments, and to answer any additional questions.
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This study's enrollment of 40 is below the median of 78 across 4,878 interventional studies indexed under Obesity.
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Exclusion criteria:
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.
Drug: Liraglutide
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.
Drug: Placebo
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.
Also known as: Saxenda
Gastric Emptying of Solids Half-time (T1/2) at 5 Weeks
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.
Time frame: 5 weeks
Gastric Emptying of Solids Half-time (T1/2) at 16 Weeks
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.
Time frame: 16 weeks
Weight Change at 5 Weeks
Body weight in kg was measured at 5 weeks and compared to baseline.
Time frame: baseline, 5 weeks
Weight Change at 16 Weeks
Body weight in kg was measured at 16 weeks and compared to baseline.
Time frame: baseline, 16 weeks
Satiety by Buffet Meal, Total Calories Ingested at 16 Weeks
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.
Time frame: 16 weeks
Satiation Volume to Fullness at 16 Weeks
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).
Time frame: 16 weeks
Satiation Maximum Tolerated Volume at 16 Weeks
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).
Time frame: 16 weeks
Gastric Fasting Volume at 16 Weeks
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.
Time frame: 16 weeks
Gastric Postprandial Volume at 16 Weeks
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.
Time frame: 16 weeks
Gastric Accommodation Volume at 16 Weeks
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.
Time frame: 16 weeks (approximately 1 hour after 99mTC injection)
Participants were enrolled between December 18, 2015 and September 1, 2016 at the Mayo Clinic in Rochester, Minnesota.
| Milestone | Liraglutide | Placebo |
|---|---|---|
| Started | 19 | 21 |
| Completed | 17 | 18 |
| Not completed | 2 | 3 |
| Withdrew: Withdrawal by subject | 0 | 3 |
| Withdrew: Adverse event | 2 | 0 |
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.
| minutes | Liraglutide | Placebo |
|---|---|---|
| Gastric Emptying of Solids Half-time (T1/2) at 5 Weeks | 180 (162 to 295) | 117 (96 to 137) |
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.
| minutes | Liraglutide | Placebo |
|---|---|---|
| Gastric Emptying of Solids Half-time (T1/2) at 16 Weeks | 142 (120 to 177) | 113 (101 to 133) |
Body weight in kg was measured at 5 weeks and compared to baseline.
| kg | Liraglutide | Placebo |
|---|---|---|
| Weight Change at 5 Weeks | 3.70 (2.80 to 4.80) | 0.60 (-0.30 to 1.4) |
Body weight in kg was measured at 16 weeks and compared to baseline.
| kg | Liraglutide | Placebo |
|---|---|---|
| Weight Change at 16 Weeks | 5.30 (5.20 to 6.80) | 2.5 (0.1 to 4.2) |
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.
| kcal | Liraglutide | Placebo |
|---|---|---|
| Satiety by Buffet Meal, Total Calories Ingested at 16 Weeks | 554.0 (406 to 687) | 680.5 (513 to 1002) |
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).
| mL | Liraglutide | Placebo |
|---|---|---|
| Satiation Volume to Fullness at 16 Weeks | 360 (360 to 600) | 600 (480 to 720) |
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).
| mL | Liraglutide | Placebo |
|---|---|---|
| Satiation Maximum Tolerated Volume at 16 Weeks | 750 (651 to 908) | 1126 (944 to 1185) |
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.
| mL | Liraglutide | Placebo |
|---|---|---|
| Gastric Fasting Volume at 16 Weeks | 231 (192 to 277) | 192 (179 to 223) |
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.
| mL | Liraglutide | Placebo |
|---|---|---|
| Gastric Postprandial Volume at 16 Weeks | 705 (633 to 744) | 668 (605 to 794) |
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.
| mL | Liraglutide | Placebo |
|---|---|---|
| Gastric Accommodation Volume at 16 Weeks | 453 (378 to 536) | 433 (408 to 602) |
Collected over 16 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Liraglutide | 0/19 (0%) | 0/19 (0%) | 17/19 (89.5%) |
| Placebo | 0/21 (0%) | 0/21 (0%) | 14/21 (66.7%) |
| Event | Liraglutide | Placebo |
|---|---|---|
| NauseaGastrointestinal disorders | 12/19 | 2/21 |
| HeadacheGeneral disorders | 5/19 | 4/21 |
| Abdominal pain/discomfortGastrointestinal disorders | 4/19 | 2/21 |
| Abdominal CrampingGastrointestinal disorders | 3/19 | 2/21 |
| Loose stoolsGastrointestinal disorders | 3/19 | 1/21 |
| Decreased appetiteGastrointestinal disorders | 3/19 | 1/21 |
| DiarrheaGastrointestinal disorders | 1/19 | 3/21 |
| BloatingGastrointestinal disorders | 2/19 | 2/21 |
| ConstipationGastrointestinal disorders | 2/19 | 2/21 |
| LightheadedGeneral disorders | 1/19 | 2/21 |
Intent to treat analysis
| Age, Continuous(years) | Liraglutide | Placebo | Total |
|---|---|---|---|
| Mean | 40.95 ± 11.08 | 37.81 ± 12.14 | 39.30 ± 11.61 |
| Sex: Female, Male(Participants) | Liraglutide | Placebo | Total |
|---|---|---|---|
| Female | 17 | 18 | 35 |
| Male | 2 | 3 | 5 |
| Race/Ethnicity, Customized(Participants) | Liraglutide | Placebo | Total |
|---|---|---|---|
| White Non-Hispanic | 17 | 19 | 36 |
| Asian | 1 | 0 | 1 |
| Hispanic or Latino | 0 | 2 | 2 |
| Other | 1 | 0 | 1 |
| Region of Enrollment(Participants) | Liraglutide | Placebo | Total |
|---|---|---|---|
| United States | 19 | 21 | 40 |
| Body Mass Index (BMI)(kg/m^2) | Liraglutide | Placebo | Total |
|---|---|---|---|
| Mean | 37.2 (33.6 to 41.0) | 34.6 (33.4 to 38.9) | 36.65 (33.5 to 39.5) |
| Body Weight(kg) | Liraglutide | Placebo | Total |
|---|---|---|---|
| Mean | 103.7 (90.0 to 112.2) | 99.1 (90.1 to 111.2) | 103 (90.0 to 111.5) |
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