Trial Outcomes & Findings for Pilot Study of the Effect of Liraglutide 3.0 mg on Weight Loss and Gastric Functions in Obesity (NCT NCT03523273)
NCT ID: NCT03523273
Last Updated: 2022-06-23
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
136 participants
Primary outcome timeframe
5 weeks
Results posted on
2022-06-23
Participant Flow
Participant milestones
| Measure |
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.
|
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
|
67
|
69
|
|
Overall Study
COMPLETED
|
59
|
65
|
|
Overall Study
NOT COMPLETED
|
8
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pilot Study of the Effect of Liraglutide 3.0 mg on Weight Loss and Gastric Functions in Obesity
Baseline characteristics by cohort
| Measure |
Liraglutide
n=67 Participants
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
n=69 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=136 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42 years
n=99 Participants
|
37.2 years
n=107 Participants
|
37.7 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
59 Participants
n=99 Participants
|
59 Participants
n=107 Participants
|
118 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
60 Participants
n=99 Participants
|
65 Participants
n=107 Participants
|
125 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
67 participants
n=99 Participants
|
69 participants
n=107 Participants
|
136 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 5 weeksThe 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.
Outcome measures
| Measure |
Liraglutide
n=67 Participants
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
n=69 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.
|
|---|---|---|
|
Gastric Emptying of Solids (T1/2)
|
191.6 minutes
Interval 137.0 to 241.0
|
105.9 minutes
Interval 92.6 to 127.8
|
PRIMARY outcome
Timeframe: 16 weeksThe 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.
Outcome measures
| Measure |
Liraglutide
n=67 Participants
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
n=69 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.
|
|---|---|---|
|
Gastric Emptying of Solids (T1/2)
|
154.4 minutes
Interval 120.4 to 178.3
|
111.4 minutes
Interval 97.3 to 132.9
|
SECONDARY outcome
Timeframe: baseline, 5 weeksChange in subject's weight, in kilograms
Outcome measures
| Measure |
Liraglutide
n=67 Participants
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
n=69 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.
|
|---|---|---|
|
Change in Weight at 5 Weeks
|
-3.8 kilograms
Interval -4.8 to -2.5
|
0.1 kilograms
Interval -1.5 to 1.4
|
SECONDARY outcome
Timeframe: baseline, 16 weeksChange in subject's weight, in kilograms
Outcome measures
| Measure |
Liraglutide
n=67 Participants
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
n=69 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.
|
|---|---|---|
|
Change in Weight at 16 Weeks
|
-5.8 kilograms
Interval -8.3 to -3.9
|
0.0 kilograms
Interval -3.1 to 2.1
|
SECONDARY outcome
Timeframe: 16 weeksSubjects self-reported fullness after eating as much of a prescribed meal measured by kilocalories of food consumed.
Outcome measures
| Measure |
Liraglutide
n=67 Participants
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
n=69 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.
|
|---|---|---|
|
Satiety
|
647.5 kilocalories
Interval 472.4 to 826.4
|
793.7 kilocalories
Interval 624.6 to 1019.3
|
SECONDARY outcome
Timeframe: 16 weeksSubjects 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).
Outcome measures
| Measure |
Liraglutide
n=67 Participants
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
n=69 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.
|
|---|---|---|
|
Satiation Volume to Fullness
|
622.1 milliliters (mL)
Interval 496.7 to 746.6
|
746.6 milliliters (mL)
Interval 497.7 to 871.0
|
SECONDARY outcome
Timeframe: 16 weeksSubjects 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).
Outcome measures
| Measure |
Liraglutide
n=67 Participants
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
n=69 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.
|
|---|---|---|
|
Maximum Satiation
|
974.4 milliliters (mL)
Interval 746.6 to 1156.3
|
1119.8 milliliters (mL)
Interval 995.4 to 1430.9
|
SECONDARY outcome
Timeframe: 16 weeksGastric fasting volume was measured prior to a meal of 300 mL Ensure drink using noninvasive single photon emission-computed tomography (SPECT) of the stomach.
Outcome measures
| Measure |
Liraglutide
n=67 Participants
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
n=69 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.
|
|---|---|---|
|
Fasting Gastric Volume Prior to Meal
|
221.2 milliliters (mL)
Interval 187.7 to 269.8
|
191.5 milliliters (mL)
Interval 176.5 to 231.5
|
SECONDARY outcome
Timeframe: 16 weeksGastric volume was measured after a meal of 300 mL Ensure drink using noninvasive single photon emission-computed tomography (SPECT) of the stomach.
Outcome measures
| Measure |
Liraglutide
n=67 Participants
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
n=69 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.
|
|---|---|---|
|
Gastric Volume After Meal
|
629.1 milliliters (mL)
Interval 538.9 to 705.1
|
583.8 milliliters (mL)
Interval 549.8 to 667.7
|
SECONDARY outcome
Timeframe: 16 weeksMeasured in milliliters (mL), using the difference between the fasting gastric volume prior to the meal and the gastric volume after the meal.
Outcome measures
| Measure |
Liraglutide
n=67 Participants
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
n=69 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.
|
|---|---|---|
|
Gastric Accommodation
|
385.4 milliliters (mL)
Interval 332.6 to 445.2
|
391.8 milliliters (mL)
Interval 348.6 to 433.5
|
Adverse Events
Liraglutide
Serious events: 1 serious events
Other events: 67 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 56 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Liraglutide
n=67 participants at risk
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
n=69 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
Cholecystectomy for acute cholecystitis associated with gallstones
|
1.5%
1/67 • Number of events 1 • Adverse events will be collected from baseline to end of study participation for a total of approximately 18 weeks on all participants.
|
1.4%
1/69 • Number of events 1 • Adverse events will be collected from baseline to end of study participation for a total of approximately 18 weeks on all participants.
|
Other adverse events
| Measure |
Liraglutide
n=67 participants at risk
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
n=69 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
|
59.7%
40/67 • Number of events 40 • Adverse events will be collected from baseline to end of study participation for a total of approximately 18 weeks on all participants.
|
15.9%
11/69 • Number of events 11 • Adverse events will be collected from baseline to end of study participation for a total of approximately 18 weeks on all participants.
|
|
Gastrointestinal disorders
Diarrhea
|
34.3%
23/67 • Number of events 23 • Adverse events will be collected from baseline to end of study participation for a total of approximately 18 weeks on all participants.
|
8.7%
6/69 • Number of events 6 • Adverse events will be collected from baseline to end of study participation for a total of approximately 18 weeks on all participants.
|
|
Gastrointestinal disorders
Abdominal pain/discomfort
|
28.4%
19/67 • Number of events 19 • Adverse events will be collected from baseline to end of study participation for a total of approximately 18 weeks on all participants.
|
5.8%
4/69 • Number of events 4 • Adverse events will be collected from baseline to end of study participation for a total of approximately 18 weeks on all participants.
|
|
Gastrointestinal disorders
Constipation
|
26.9%
18/67 • Number of events 18 • Adverse events will be collected from baseline to end of study participation for a total of approximately 18 weeks on all participants.
|
5.8%
4/69 • Number of events 4 • Adverse events will be collected from baseline to end of study participation for a total of approximately 18 weeks on all participants.
|
|
General disorders
Headache
|
26.9%
18/67 • Number of events 18 • Adverse events will be collected from baseline to end of study participation for a total of approximately 18 weeks on all participants.
|
14.5%
10/69 • Number of events 10 • Adverse events will be collected from baseline to end of study participation for a total of approximately 18 weeks on all participants.
|
|
General disorders
Bruising at injection site
|
19.4%
13/67 • Number of events 13 • Adverse events will be collected from baseline to end of study participation for a total of approximately 18 weeks on all participants.
|
13.0%
9/69 • Number of events 9 • Adverse events will be collected from baseline to end of study participation for a total of approximately 18 weeks on all participants.
|
|
General disorders
Bloating
|
16.4%
11/67 • Number of events 11 • Adverse events will be collected from baseline to end of study participation for a total of approximately 18 weeks on all participants.
|
7.2%
5/69 • Number of events 5 • Adverse events will be collected from baseline to end of study participation for a total of approximately 18 weeks on all participants.
|
|
General disorders
Burping/Belching
|
9.0%
6/67 • Number of events 6 • Adverse events will be collected from baseline to end of study participation for a total of approximately 18 weeks on all participants.
|
0.00%
0/69 • Adverse events will be collected from baseline to end of study participation for a total of approximately 18 weeks on all participants.
|
|
Gastrointestinal disorders
Abdominal cramping
|
9.0%
6/67 • Number of events 6 • Adverse events will be collected from baseline to end of study participation for a total of approximately 18 weeks on all participants.
|
4.3%
3/69 • Number of events 3 • Adverse events will be collected from baseline to end of study participation for a total of approximately 18 weeks on all participants.
|
|
General disorders
Lightheaded
|
7.5%
5/67 • Number of events 5 • Adverse events will be collected from baseline to end of study participation for a total of approximately 18 weeks on all participants.
|
5.8%
4/69 • Number of events 4 • Adverse events will be collected from baseline to end of study participation for a total of approximately 18 weeks on all participants.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place