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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02647944
Recruitment Status : Completed
First Posted : January 6, 2016
Results First Posted : October 27, 2017
Last Update Posted : October 27, 2017
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Novo Nordisk A/S
Information provided by (Responsible Party):
Michael Camilleri, Mayo Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Obesity
Interventions Drug: Liraglutide
Drug: Placebo
Enrollment 40
Recruitment Details Participants were enrolled between December 18, 2015 and September 1, 2016 at the Mayo Clinic in Rochester, Minnesota.
Pre-assignment Details  
Arm/Group Title Liraglutide Placebo
Hide Arm/Group Description 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 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.
Period Title: Overall Study
Started 19 21
Completed 17 18
Not Completed 2 3
Reason Not Completed
Withdrawal by Subject             0             3
Adverse Event             2             0
Arm/Group Title Liraglutide Placebo Total
Hide Arm/Group Description 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 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. Total of all reporting groups
Overall Number of Baseline Participants 19 21 40
Hide Baseline Analysis Population Description
Intent to treat analysis
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 21 participants 40 participants
40.95  (11.08) 37.81  (12.14) 39.30  (11.61)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 21 participants 40 participants
Female
17
  89.5%
18
  85.7%
35
  87.5%
Male
2
  10.5%
3
  14.3%
5
  12.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
White Non-Hispanic Number Analyzed 19 participants 21 participants 40 participants
17
  89.5%
19
  90.5%
36
  90.0%
Asian Number Analyzed 19 participants 21 participants 40 participants
1
   5.3%
0
   0.0%
1
   2.5%
Hispanic or Latino Number Analyzed 19 participants 21 participants 40 participants
0
   0.0%
2
   9.5%
2
   5.0%
Other Number Analyzed 19 participants 21 participants 40 participants
1
   5.3%
0
   0.0%
1
   2.5%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 19 participants 21 participants 40 participants
19
 100.0%
21
 100.0%
40
 100.0%
Body Mass Index (BMI)  
Mean (Inter-Quartile Range)
Unit of measure:  Kg/m^2
Number Analyzed 19 participants 21 participants 40 participants
37.2
(33.6 to 41.0)
34.6
(33.4 to 38.9)
36.65
(33.5 to 39.5)
Body Weight   [1] 
Mean (Inter-Quartile Range)
Unit of measure:  Kg
Number Analyzed 19 participants 20 participants 39 participants
103.7
(90.0 to 112.2)
99.1
(90.1 to 111.2)
103
(90.0 to 111.5)
[1]
Measure Analysis Population Description: Body weight was not recorded at baseline for one participant in the placebo group.
1.Primary Outcome
Title Gastric Emptying of Solids Half-time (T1/2) at 5 Weeks
Hide 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.
Time Frame 5 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat analysis; data were imputed for the 5 participants who dropped out.
Arm/Group Title Liraglutide Placebo
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 19 21
Median (Inter-Quartile Range)
Unit of Measure: minutes
180
(162 to 295)
117
(96 to 137)
2.Primary Outcome
Title Gastric Emptying of Solids Half-time (T1/2) at 16 Weeks
Hide 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.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat analysis; data were imputed for the 5 participants who dropped out.
Arm/Group Title Liraglutide Placebo
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 19 21
Median (Inter-Quartile Range)
Unit of Measure: minutes
142
(120 to 177)
113
(101 to 133)
3.Secondary Outcome
Title Weight Change at 5 Weeks
Hide Description Body weight in kg was measured at 5 weeks and compared to baseline.
Time Frame baseline, 5 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat analysis; data were imputed for the 5 participants who dropped out.
Arm/Group Title Liraglutide Placebo
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 19 21
Median (Inter-Quartile Range)
Unit of Measure: kg
3.70
(2.80 to 4.80)
0.60
(-0.30 to 1.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
4.Secondary Outcome
Title Weight Change at 16 Weeks
Hide Description Body weight in kg was measured at 16 weeks and compared to baseline.
Time Frame baseline, 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat analysis; data were imputed for the 5 participants who dropped out.
Arm/Group Title Liraglutide Placebo
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 19 21
Median (Inter-Quartile Range)
Unit of Measure: kg
5.30
(5.20 to 6.80)
2.5
(0.1 to 4.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
5.Secondary Outcome
Title Satiety by Buffet Meal, Total Calories Ingested at 16 Weeks
Hide 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.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat analysis; data were imputed for the 5 participants who dropped out.
Arm/Group Title Liraglutide Placebo
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 19 21
Median (Inter-Quartile Range)
Unit of Measure: kcal
554.0
(406 to 687)
680.5
(513 to 1002)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.27
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
6.Secondary Outcome
Title Satiation Volume to Fullness at 16 Weeks
Hide 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).
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat analysis; data were imputed for the 5 participants who dropped out.
Arm/Group Title Liraglutide Placebo
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 19 21
Median (Inter-Quartile Range)
Unit of Measure: mL
360
(360 to 600)
600
(480 to 720)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.069
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
7.Secondary Outcome
Title Satiation Maximum Tolerated Volume at 16 Weeks
Hide 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).
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat analysis; data were imputed for the 5 participants who dropped out.
Arm/Group Title Liraglutide Placebo
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 19 21
Median (Inter-Quartile Range)
Unit of Measure: mL
750
(651 to 908)
1126
(944 to 1185)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.054
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
8.Secondary Outcome
Title Gastric Fasting Volume at 16 Weeks
Hide 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.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat analysis; data were imputed for the 5 participants who dropped out.
Arm/Group Title Liraglutide Placebo
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 19 21
Median (Inter-Quartile Range)
Unit of Measure: mL
231
(192 to 277)
192
(179 to 223)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.13
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
9.Secondary Outcome
Title Gastric Postprandial Volume at 16 Weeks
Hide 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.
Time Frame 16 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat analysis; data were imputed for the 5 participants who dropped out.
Arm/Group Title Liraglutide Placebo
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 19 21
Median (Inter-Quartile Range)
Unit of Measure: mL
705
(633 to 744)
668
(605 to 794)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.68
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
10.Secondary Outcome
Title Gastric Accommodation Volume at 16 Weeks
Hide 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.
Time Frame 16 weeks (approximately 1 hour after 99mTC injection)
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat analysis; data were imputed for the 5 participants who dropped out.
Arm/Group Title Liraglutide Placebo
Hide Arm/Group Description:
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 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.
Overall Number of Participants Analyzed 19 21
Median (Inter-Quartile Range)
Unit of Measure: mL
453
(378 to 536)
433
(408 to 602)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Liraglutide, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.95
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame 16 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Liraglutide Placebo
Hide Arm/Group Description 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 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.
All-Cause Mortality
Liraglutide Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)      0/21 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Liraglutide Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/19 (0.00%)      0/21 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Liraglutide Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   17/19 (89.47%)      14/21 (66.67%)    
Gastrointestinal disorders     
Nausea   12/19 (63.16%)  31 2/21 (9.52%)  5
Bloating   2/19 (10.53%)  4 2/21 (9.52%)  2
Constipation   2/19 (10.53%)  5 2/21 (9.52%)  2
Diarrhea   1/19 (5.26%)  1 3/21 (14.29%)  3
Abdominal pain/discomfort   4/19 (21.05%)  5 2/21 (9.52%)  3
Abdominal Cramping   3/19 (15.79%)  4 2/21 (9.52%)  3
Loose stools   3/19 (15.79%)  3 1/21 (4.76%)  2
Decreased appetite   3/19 (15.79%)  3 1/21 (4.76%)  1
General disorders     
Headache   5/19 (26.32%)  7 4/21 (19.05%)  5
Lightheaded   1/19 (5.26%)  1 2/21 (9.52%)  2
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Michael Camilleri
Organization: Mayo Clinic
Phone: 507-284-6218
EMail: camilleri.michael@mayo.edu
Layout table for additonal information
Responsible Party: Michael Camilleri, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02647944     History of Changes
Other Study ID Numbers: 15-001783
R56DK067071 ( U.S. NIH Grant/Contract )
UL1TR000135 ( U.S. NIH Grant/Contract )
First Submitted: December 31, 2015
First Posted: January 6, 2016
Results First Submitted: September 29, 2017
Results First Posted: October 27, 2017
Last Update Posted: October 27, 2017