Trial Outcomes & Findings for Pilot Study of the Effect of Liraglutide on Weight Loss and Gastric Functions in Obesity (NCT NCT02647944)

NCT ID: NCT02647944

Last Updated: 2017-10-27

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 40 participants
• Primary outcome timeframe: 5 weeks
• Results posted on: 2017-10-27

Participant Flow

Participants were enrolled between December 18, 2015 and September 1, 2016 at the Mayo Clinic in Rochester, Minnesota.

Participant milestones

Measure	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 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 Study STARTED	19	21
Overall Study COMPLETED	17	18
Overall Study NOT COMPLETED	2	3

Reasons for withdrawal

Measure	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 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 Study Withdrawal by Subject	0	3
Overall Study Adverse Event	2	0

Baseline Characteristics

Body weight was not recorded at baseline for one participant in the placebo group.

Baseline characteristics by cohort

Measure	Liraglutide n=19 Participants 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 n=21 Participants 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 n=40 Participants Total of all reporting groups
Age, Continuous	40.95 years STANDARD_DEVIATION 11.08 • n=19 Participants	37.81 years STANDARD_DEVIATION 12.14 • n=21 Participants	39.30 years STANDARD_DEVIATION 11.61 • n=40 Participants
Sex: Female, Male Female	17 Participants n=19 Participants	18 Participants n=21 Participants	35 Participants n=40 Participants
Sex: Female, Male Male	2 Participants n=19 Participants	3 Participants n=21 Participants	5 Participants n=40 Participants
Race/Ethnicity, Customized White Non-Hispanic	17 Participants n=19 Participants	19 Participants n=21 Participants	36 Participants n=40 Participants
Race/Ethnicity, Customized Asian	1 Participants n=19 Participants	0 Participants n=21 Participants	1 Participants n=40 Participants
Race/Ethnicity, Customized Hispanic or Latino	0 Participants n=19 Participants	2 Participants n=21 Participants	2 Participants n=40 Participants
Race/Ethnicity, Customized Other	1 Participants n=19 Participants	0 Participants n=21 Participants	1 Participants n=40 Participants
Region of Enrollment United States	19 Participants n=19 Participants	21 Participants n=21 Participants	40 Participants n=40 Participants
Body Mass Index (BMI)	37.2 kg/m^2 n=19 Participants	34.6 kg/m^2 n=21 Participants	36.65 kg/m^2 n=40 Participants
Body Weight	103.7 kg n=19 Participants • Body weight was not recorded at baseline for one participant in the placebo group.	99.1 kg n=20 Participants • Body weight was not recorded at baseline for one participant in the placebo group.	103 kg n=39 Participants • Body weight was not recorded at baseline for one participant in the placebo group.

PRIMARY outcome

Timeframe: 5 weeks

Population: Intent to treat analysis; data were imputed for the 5 participants who dropped out.

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.

Outcome measures

Measure	Placebo n=21 Participants 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.	Liraglutide n=19 Participants 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.
Gastric Emptying of Solids Half-time (T1/2) at 5 Weeks	117 minutes Interval 96.0 to 137.0	180 minutes Interval 162.0 to 295.0

PRIMARY outcome

Timeframe: 16 weeks

Population: Intent to treat analysis; data were imputed for the 5 participants who dropped out.

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.

Outcome measures

Measure	Placebo n=21 Participants 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.	Liraglutide n=19 Participants 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.
Gastric Emptying of Solids Half-time (T1/2) at 16 Weeks	113 minutes Interval 101.0 to 133.0	142 minutes Interval 120.0 to 177.0

SECONDARY outcome

Timeframe: baseline, 5 weeks

Population: Intent to treat analysis; data were imputed for the 5 participants who dropped out.

Body weight in kg was measured at 5 weeks and compared to baseline.

Outcome measures

Measure	Placebo n=21 Participants 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.	Liraglutide n=19 Participants 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.
Weight Change at 5 Weeks	0.60 kg Interval -0.3 to 1.4	3.70 kg Interval 2.8 to 4.8

SECONDARY outcome

Timeframe: baseline, 16 weeks

Population: Intent to treat analysis; data were imputed for the 5 participants who dropped out.

Body weight in kg was measured at 16 weeks and compared to baseline.

Outcome measures

Measure	Placebo n=21 Participants 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.	Liraglutide n=19 Participants 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.
Weight Change at 16 Weeks	2.5 kg Interval 0.1 to 4.2	5.30 kg Interval 5.2 to 6.8

SECONDARY outcome

Timeframe: 16 weeks

Population: Intent to treat analysis; data were imputed for the 5 participants who dropped out.

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.

Outcome measures

Measure	Placebo n=21 Participants 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.	Liraglutide n=19 Participants 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.
Satiety by Buffet Meal, Total Calories Ingested at 16 Weeks	680.5 kcal Interval 513.0 to 1002.0	554.0 kcal Interval 406.0 to 687.0

SECONDARY outcome

Timeframe: 16 weeks

Population: Intent to treat analysis; data were imputed for the 5 participants who dropped out.

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).

Outcome measures

Measure	Placebo n=21 Participants 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.	Liraglutide n=19 Participants 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.
Satiation Volume to Fullness at 16 Weeks	600 mL Interval 480.0 to 720.0	360 mL Interval 360.0 to 600.0

SECONDARY outcome

Timeframe: 16 weeks

Population: Intent to treat analysis; data were imputed for the 5 participants who dropped out.

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).

Outcome measures

Measure	Placebo n=21 Participants 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.	Liraglutide n=19 Participants 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.
Satiation Maximum Tolerated Volume at 16 Weeks	1126 mL Interval 944.0 to 1185.0	750 mL Interval 651.0 to 908.0

SECONDARY outcome

Timeframe: 16 weeks

Population: Intent to treat analysis; data were imputed for the 5 participants who dropped out.

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.

Outcome measures

Measure	Placebo n=21 Participants 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.	Liraglutide n=19 Participants 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.
Gastric Fasting Volume at 16 Weeks	192 mL Interval 179.0 to 223.0	231 mL Interval 192.0 to 277.0

SECONDARY outcome

Timeframe: 16 weeks

Population: Intent to treat analysis; data were imputed for the 5 participants who dropped out.

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.

Outcome measures

Measure	Placebo n=21 Participants 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.	Liraglutide n=19 Participants 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.
Gastric Postprandial Volume at 16 Weeks	668 mL Interval 605.0 to 794.0	705 mL Interval 633.0 to 744.0

SECONDARY outcome

Timeframe: 16 weeks (approximately 1 hour after 99mTC injection)

Population: Intent to treat analysis; data were imputed for the 5 participants who dropped out.

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.

Outcome measures

Measure	Placebo n=21 Participants 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.	Liraglutide n=19 Participants 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.
Gastric Accommodation Volume at 16 Weeks	433 mL Interval 408.0 to 602.0	453 mL Interval 378.0 to 536.0

Adverse Events

Liraglutide

Serious events: 0 serious events

Other events: 17 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Liraglutide n=19 participants at risk 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 n=21 participants at risk 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.
Gastrointestinal disorders Nausea	63.2% 12/19 • Number of events 31 • 16 weeks	9.5% 2/21 • Number of events 5 • 16 weeks
Gastrointestinal disorders Bloating	10.5% 2/19 • Number of events 4 • 16 weeks	9.5% 2/21 • Number of events 2 • 16 weeks
Gastrointestinal disorders Constipation	10.5% 2/19 • Number of events 5 • 16 weeks	9.5% 2/21 • Number of events 2 • 16 weeks
Gastrointestinal disorders Diarrhea	5.3% 1/19 • Number of events 1 • 16 weeks	14.3% 3/21 • Number of events 3 • 16 weeks
General disorders Headache	26.3% 5/19 • Number of events 7 • 16 weeks	19.0% 4/21 • Number of events 5 • 16 weeks
Gastrointestinal disorders Abdominal pain/discomfort	21.1% 4/19 • Number of events 5 • 16 weeks	9.5% 2/21 • Number of events 3 • 16 weeks
Gastrointestinal disorders Abdominal Cramping	15.8% 3/19 • Number of events 4 • 16 weeks	9.5% 2/21 • Number of events 3 • 16 weeks
General disorders Lightheaded	5.3% 1/19 • Number of events 1 • 16 weeks	9.5% 2/21 • Number of events 2 • 16 weeks
Gastrointestinal disorders Loose stools	15.8% 3/19 • Number of events 3 • 16 weeks	4.8% 1/21 • Number of events 2 • 16 weeks
Gastrointestinal disorders Decreased appetite	15.8% 3/19 • Number of events 3 • 16 weeks	4.8% 1/21 • Number of events 1 • 16 weeks

Additional Information

Dr. Michael Camilleri

Mayo Clinic

Phone: 507-284-6218

Email: camilleri.michael@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place