Pilot Study of the Effect of Liraglutide 3.0 mg on Weight Loss and Gastric Functions in Obesity

• Sponsor: Michael Camilleri, MD (Other)
• Overall Status: Completed
• CT.gov ID: NCT03523273
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH), Novo Nordisk A/S (Industry)
• Enrollment: 136
• Location: 1
• Arms: 2
• Actual Duration (Months): 45
• Patients Per Site Per Month: 3

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Drug: Liraglutide; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 136 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Pilot Study of the Effect of Liraglutide 3.0 mg on Weight Loss and Gastric Functions in Obesity
• Actual Study Start Date: Nov 29, 2017
• Actual Primary Completion Date: Aug 31, 2021
• Actual Study Completion Date: Aug 31, 2021

Arms and Interventions

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.	Drug: Liraglutide; 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: Saxenda Victoza
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.	Drug: Placebo; Placebo administration will match the study drug.

Outcome Measures

Primary Outcome Measures

1. Gastric Emptying of Solids (T1/2) [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.

2. Gastric Emptying of Solids (T1/2) [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.

Secondary Outcome Measures

1. Change in Weight at 5 Weeks [baseline, 5 weeks]

   Change in subject's weight, in kilograms

2. Change in Weight at 16 Weeks [baseline, 16 weeks]

   Change in subject's weight, in kilograms

3. Satiety [16 weeks]

   Subjects self-reported fullness after eating as much of a prescribed meal measured by kilocalories of food consumed.

4. Satiation Volume to Fullness [16 weeks]

   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).

5. Maximum Satiation [16 weeks]

   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).

6. Fasting Gastric Volume Prior to Meal [16 weeks]

   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.

7. Gastric Volume After Meal [16 weeks]

   Gastric volume was measured after a meal of 300 mL Ensure drink using noninvasive single photon emission-computed tomography (SPECT) of the stomach.

8. Gastric Accommodation [16 weeks]

   Measured in milliliters (mL), using the difference between the fasting gastric volume prior to the meal and the gastric volume after the meal.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

• Michael Camilleri, MD
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Novo Nordisk A/S

Investigators

• Principal Investigator: Michael Camilleri, MD, Mayo Clinic

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 29, 2020
• Informed Consent Form - Jun 3, 2020

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: Michael Camilleri, MD, Principal Investigator, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT03523273
• Other Study ID Numbers: 15-001783 Part B; R56DK067071; UL1TR000135
• First Posted: May 14, 2018
• Last Update Posted: Jun 23, 2022
• Last Verified: May 1, 2022

• 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
• Additional relevant MeSH terms: Obesity; Weight Loss; Liraglutide

Study Results

Participant Flow

Arm/Group Title	Liraglutide	Placebo
Arm/Group Description	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.	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	67	69
COMPLETED	59	65
NOT COMPLETED	8	4

Baseline Characteristics

Arm/Group Title	Liraglutide	Placebo	Total
Arm/Group Description	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.	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 Participants	67	69	136
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	42	37.2	37.7
Sex: Female, Male (Count of Participants)
Female	59 88.1%	59 85.5%	118 86.8%
Male	8 11.9%	10 14.5%	18 13.2%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	60 89.6%	65 94.2%	125 91.9%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	7 10.4%	4 5.8%	11 8.1%
Region of Enrollment (participants) [Number]
United States	67 100%	69 100%	136 100%

Outcome Measures

1. Primary Outcome

Title	Gastric Emptying of Solids (T1/2)
Description	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.
Time Frame	5 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Liraglutide	Placebo
Arm/Group Description	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.	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.
Measure Participants	67	69
Median (Inter-Quartile Range) [minutes]	191.6	105.9

2. Primary Outcome

Title	Gastric Emptying of Solids (T1/2)
Description	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.
Time Frame	16 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Liraglutide	Placebo
Arm/Group Description	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.	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.
Measure Participants	67	69
Median (Inter-Quartile Range) [minutes]	154.4	111.4

3. Secondary Outcome

Title	Change in Weight at 5 Weeks
Description	Change in subject's weight, in kilograms
Time Frame	baseline, 5 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Liraglutide	Placebo
Arm/Group Description	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.	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.
Measure Participants	67	69
Median (Inter-Quartile Range) [kilograms]	-3.8	0.1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Liraglutide, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.004
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

4. Secondary Outcome

Title	Change in Weight at 16 Weeks
Description	Change in subject's weight, in kilograms
Time Frame	baseline, 16 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Liraglutide	Placebo
Arm/Group Description	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.	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.
Measure Participants	67	69
Median (Inter-Quartile Range) [kilograms]	-5.8	0.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Liraglutide, Placebo
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.033
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

5. Secondary Outcome

Title	Satiety
Description	Subjects self-reported fullness after eating as much of a prescribed meal measured by kilocalories of food consumed.
Time Frame	16 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Liraglutide	Placebo
Arm/Group Description	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.	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.
Measure Participants	67	69
Median (Inter-Quartile Range) [kilocalories]	647.5	793.7

6. Secondary Outcome

Title	Satiation Volume to Fullness
Description	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).
Time Frame	16 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Liraglutide	Placebo
Arm/Group Description	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.	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.
Measure Participants	67	69
Median (Inter-Quartile Range) [milliliters (mL)]	622.1	746.6

7. Secondary Outcome

Title	Maximum Satiation
Description	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).
Time Frame	16 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Liraglutide	Placebo
Arm/Group Description	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.	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.
Measure Participants	67	69
Median (Inter-Quartile Range) [milliliters (mL)]	974.4	1119.8

8. Secondary Outcome

Title	Fasting Gastric Volume Prior to Meal
Description	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.
Time Frame	16 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Liraglutide	Placebo
Arm/Group Description	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.	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.
Measure Participants	67	69
Median (Inter-Quartile Range) [milliliters (mL)]	221.2	191.5

9. Secondary Outcome

Title	Gastric Volume After Meal
Description	Gastric volume was measured after a meal of 300 mL Ensure drink using noninvasive single photon emission-computed tomography (SPECT) of the stomach.
Time Frame	16 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Liraglutide	Placebo
Arm/Group Description	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.	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.
Measure Participants	67	69
Median (Inter-Quartile Range) [milliliters (mL)]	629.1	583.8

10. Secondary Outcome

Title	Gastric Accommodation
Description	Measured in milliliters (mL), using the difference between the fasting gastric volume prior to the meal and the gastric volume after the meal.
Time Frame	16 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Liraglutide	Placebo
Arm/Group Description	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.	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.
Measure Participants	67	69
Median (Inter-Quartile Range) [milliliters (mL)]	385.4	391.8

Adverse Events

Time Frame	Adverse events will be collected from baseline to end of study participation for a total of approximately 18 weeks on all participants.
Arm/Group Title	Liraglutide		Placebo
Arm/Group Description	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.		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 (%)	# Events	Affected / at Risk (%)	# Events
Total	0/67 (0%)		0/69 (0%)
Serious Adverse Events
	Liraglutide		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/67 (1.5%)		1/69 (1.4%)
Gastrointestinal disorders
Cholecystectomy for acute cholecystitis associated with gallstones	1/67 (1.5%)	1	1/69 (1.4%)	1
Other (Not Including Serious) Adverse Events
	Liraglutide		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	67/67 (100%)		56/69 (81.2%)
Gastrointestinal disorders
Nausea	40/67 (59.7%)	40	11/69 (15.9%)	11
Diarrhea	23/67 (34.3%)	23	6/69 (8.7%)	6
Abdominal pain/discomfort	19/67 (28.4%)	19	4/69 (5.8%)	4
Constipation	18/67 (26.9%)	18	4/69 (5.8%)	4
Abdominal cramping	6/67 (9%)	6	3/69 (4.3%)	3
General disorders
Headache	18/67 (26.9%)	18	10/69 (14.5%)	10
Bruising at injection site	13/67 (19.4%)	13	9/69 (13%)	9
Bloating	11/67 (16.4%)	11	5/69 (7.2%)	5
Burping/Belching	6/67 (9%)	6	0/69 (0%)	0
Lightheaded	5/67 (7.5%)	5	4/69 (5.8%)	4

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.