Trial Outcomes & Findings for Use of a GLP-1R Agonist to Treat Opioid Use Disorder (NCT NCT04199728)
NCT ID: NCT04199728
Last Updated: 2024-11-06
Results Overview
Scores are measured on a 0-100 point VAS, where 0= no craving, 100= maximum craving.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
27 participants
Primary outcome timeframe
Baseline (Day 1), End of the target drug dose (Day 19)
Results posted on
2024-11-06
Participant Flow
Protocol was approved for a 3-dose intervention that could continue as a 5-dose intervention; no participants received the latter. All outcomes are reported as the 3-dose intervention.
Two participants were not randomized due to screening after consent and prior to randomization.
Participant milestones
| Measure |
Investigational Group
Participants randomized to liraglutide will be started at a low dose (0.6 mg once per day) which will be gradually increased until 1.8 mg/day is reached for the 3-dose intervention and 3 mg/day is reached for the 5-dose intervention. Liraglutide will be administered by injection pen.
Liraglutide Pen Injector: Liraglutide will be provided using an injection pen provided by the manufacturer
|
Control Group
Participants in the control group will have placebo administered by injection pen following the same low dose titration to 3.0 mg once per day.
Placebo: Placebo injection pen
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
13
|
|
Overall Study
COMPLETED
|
1
|
8
|
|
Overall Study
NOT COMPLETED
|
11
|
5
|
Reasons for withdrawal
| Measure |
Investigational Group
Participants randomized to liraglutide will be started at a low dose (0.6 mg once per day) which will be gradually increased until 1.8 mg/day is reached for the 3-dose intervention and 3 mg/day is reached for the 5-dose intervention. Liraglutide will be administered by injection pen.
Liraglutide Pen Injector: Liraglutide will be provided using an injection pen provided by the manufacturer
|
Control Group
Participants in the control group will have placebo administered by injection pen following the same low dose titration to 3.0 mg once per day.
Placebo: Placebo injection pen
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
8
|
3
|
|
Overall Study
Screen fail after consent
|
0
|
1
|
|
Overall Study
Early withdraw criteria met
|
0
|
1
|
|
Overall Study
Non-compliance/difficulty with staff
|
2
|
0
|
Baseline Characteristics
Use of a GLP-1R Agonist to Treat Opioid Use Disorder
Baseline characteristics by cohort
| Measure |
Investigational Group
n=12 Participants
Participants randomized to liraglutide will be started at a low dose (0.6 mg once per day) which will be gradually increased until 1.8 mg/day is reached for the 3-dose intervention and 3 mg/day is reached for the 5-dose intervention. Liraglutide will be administered by injection pen.
Liraglutide Pen Injector: Liraglutide will be provided using an injection pen provided by the manufacturer
|
Control Group
n=13 Participants
Participants in the control group will have placebo administered by injection pen following the same low dose titration to 3.0 mg once per day.
Placebo: Placebo injection pen
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
35.23 years
STANDARD_DEVIATION 2.04 • n=5 Participants
|
32.03 years
STANDARD_DEVIATION 2.19 • n=7 Participants
|
33.57 years
STANDARD_DEVIATION 1.51 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1), End of the target drug dose (Day 19)Population: In control group, n=1 did not complete the measure due to technical difficulties. n=7 instead of n=8 reported.
Scores are measured on a 0-100 point VAS, where 0= no craving, 100= maximum craving.
Outcome measures
| Measure |
Investigational Group
n=1 Participants
Participants randomized to liraglutide will be started at a low dose (0.6 mg once per day) which will be gradually increased until 1.8 mg/day is reached for the 3-dose intervention and 3 mg/day is reached for the 5-dose intervention. Liraglutide will be administered by injection pen.
Liraglutide Pen Injector: Liraglutide will be provided using an injection pen provided by the manufacturer
|
Control Group
n=7 Participants
Participants in the control group will have placebo administered by injection pen following the same low dose titration to 3.0 mg once per day.
Placebo: Placebo injection pen
|
|---|---|---|
|
Change in Self-reported Cue-elicited Drug Craving as Measured by Visual Analog Scale (VAS)
|
-5.00 score on a scale
Standard Deviation NA
Standard Deviation is not calculable for 1 participant
|
-13.34 score on a scale
Standard Deviation 19.58
|
PRIMARY outcome
Timeframe: Baseline (Day 1), Treatment Days (Days 2-19)Population: n=1 did not complete entire EMA. n=7 instead of n=8 reported.
Scores are measured on a 0-4 point VAS, where 0= no craving, 4= maximum craving.
Outcome measures
| Measure |
Investigational Group
n=1 Participants
Participants randomized to liraglutide will be started at a low dose (0.6 mg once per day) which will be gradually increased until 1.8 mg/day is reached for the 3-dose intervention and 3 mg/day is reached for the 5-dose intervention. Liraglutide will be administered by injection pen.
Liraglutide Pen Injector: Liraglutide will be provided using an injection pen provided by the manufacturer
|
Control Group
n=7 Participants
Participants in the control group will have placebo administered by injection pen following the same low dose titration to 3.0 mg once per day.
Placebo: Placebo injection pen
|
|---|---|---|
|
Change in Ambient Drug Craving Over Time as Measured by Visual Analog Scale (VAS)
|
-0.55 score on a scale
Standard Deviation NA
Standard Deviation is not calculable for 1 participant
|
-1.41 score on a scale
Standard Deviation 0.99
|
SECONDARY outcome
Timeframe: Baseline (Day 1); beginning of each study drug dose (Days 2, 8, 14)Blood pressure measurements in mmHg. Both systolic and diastolic pressures will be assessed during the study period.
Outcome measures
| Measure |
Investigational Group
n=1 Participants
Participants randomized to liraglutide will be started at a low dose (0.6 mg once per day) which will be gradually increased until 1.8 mg/day is reached for the 3-dose intervention and 3 mg/day is reached for the 5-dose intervention. Liraglutide will be administered by injection pen.
Liraglutide Pen Injector: Liraglutide will be provided using an injection pen provided by the manufacturer
|
Control Group
n=8 Participants
Participants in the control group will have placebo administered by injection pen following the same low dose titration to 3.0 mg once per day.
Placebo: Placebo injection pen
|
|---|---|---|
|
Change in Blood Pressure
Systolic Pressure, from Day 2
|
4.00 mmHg
Standard Deviation NA
Standard Deviation is not calculable for 1 participant
|
-0.59 mmHg
Standard Deviation 4.69
|
|
Change in Blood Pressure
Systolic Pressure, from Day 8
|
9.00 mmHg
Standard Deviation NA
Standard Deviation is not calculable for 1 participant
|
2.75 mmHg
Standard Deviation 6.67
|
|
Change in Blood Pressure
Systolic Pressure, from Day 14
|
3.75 mmHg
Standard Deviation NA
Standard Deviation is not calculable for 1 participant
|
2.13 mmHg
Standard Deviation 8.13
|
|
Change in Blood Pressure
Diastolic Pressure, from Day 2
|
3.00 mmHg
Standard Deviation NA
Standard Deviation is not calculable for 1 participant
|
2.56 mmHg
Standard Deviation 6.17
|
|
Change in Blood Pressure
Diastolic Pressure, from Day 8
|
2.25 mmHg
Standard Deviation NA
Standard Deviation is not calculable for 1 participant
|
3.34 mmHg
Standard Deviation 6.61
|
|
Change in Blood Pressure
Diastolic Pressure, from Day 14
|
2.75 mmHg
Standard Deviation NA
Standard Deviation is not calculable for 1 participant
|
4.19 mmHg
Standard Deviation 7.51
|
SECONDARY outcome
Timeframe: Baseline (Day 1); beginning of each study drug dose (Days 2, 8, 14)Heart rate measurements in beats per minute.
Outcome measures
| Measure |
Investigational Group
n=1 Participants
Participants randomized to liraglutide will be started at a low dose (0.6 mg once per day) which will be gradually increased until 1.8 mg/day is reached for the 3-dose intervention and 3 mg/day is reached for the 5-dose intervention. Liraglutide will be administered by injection pen.
Liraglutide Pen Injector: Liraglutide will be provided using an injection pen provided by the manufacturer
|
Control Group
n=8 Participants
Participants in the control group will have placebo administered by injection pen following the same low dose titration to 3.0 mg once per day.
Placebo: Placebo injection pen
|
|---|---|---|
|
Change in Heart Rate
Day 02 change from baseline
|
10.75 beats per minute
Standard Deviation NA
Standard Deviation is not calculable for 1 participant
|
-5.78 beats per minute
Standard Deviation 5.10
|
|
Change in Heart Rate
Day 08 change from baseline
|
20.00 beats per minute
Standard Deviation NA
Standard Deviation is not calculable for 1 participant
|
-2.63 beats per minute
Standard Deviation 10.98
|
|
Change in Heart Rate
Day 14 change from baseline
|
9.75 beats per minute
Standard Deviation NA
Standard Deviation is not calculable for 1 participant
|
-3.09 beats per minute
Standard Deviation 11.20
|
SECONDARY outcome
Timeframe: Baseline (Day 1); beginning of each study drug dose (Days 2, 8, 14)Respiratory rate in breaths per minute.
Outcome measures
| Measure |
Investigational Group
n=1 Participants
Participants randomized to liraglutide will be started at a low dose (0.6 mg once per day) which will be gradually increased until 1.8 mg/day is reached for the 3-dose intervention and 3 mg/day is reached for the 5-dose intervention. Liraglutide will be administered by injection pen.
Liraglutide Pen Injector: Liraglutide will be provided using an injection pen provided by the manufacturer
|
Control Group
n=8 Participants
Participants in the control group will have placebo administered by injection pen following the same low dose titration to 3.0 mg once per day.
Placebo: Placebo injection pen
|
|---|---|---|
|
Change in Respiratory Rate
Day 02 change from baseline
|
-1.00 breaths per minute
Standard Deviation NA
Standard Deviation is not calculable for 1 participant
|
0.08 breaths per minute
Standard Deviation 2.83
|
|
Change in Respiratory Rate
Day 08 change from baseline
|
0.67 breaths per minute
Standard Deviation NA
Standard Deviation is not calculable for 1 participant
|
-1.08 breaths per minute
Standard Deviation 2.74
|
|
Change in Respiratory Rate
Day 14 change from baseline
|
1.33 breaths per minute
Standard Deviation NA
Standard Deviation is not calculable for 1 participant
|
-0.13 breaths per minute
Standard Deviation 2.49
|
SECONDARY outcome
Timeframe: From Day 1 to Day 19Body weight will be measured in kilograms (kg).
Outcome measures
| Measure |
Investigational Group
n=1 Participants
Participants randomized to liraglutide will be started at a low dose (0.6 mg once per day) which will be gradually increased until 1.8 mg/day is reached for the 3-dose intervention and 3 mg/day is reached for the 5-dose intervention. Liraglutide will be administered by injection pen.
Liraglutide Pen Injector: Liraglutide will be provided using an injection pen provided by the manufacturer
|
Control Group
n=8 Participants
Participants in the control group will have placebo administered by injection pen following the same low dose titration to 3.0 mg once per day.
Placebo: Placebo injection pen
|
|---|---|---|
|
Absolute Change in Body Weight
|
0.27 kg
Standard Deviation NA
Standard Deviation is not calculable for 1 participant
|
1.05 kg
Standard Deviation 1.86
|
SECONDARY outcome
Timeframe: From Day 1 to Day 19Body weight will be measured in kilograms (kg) and change will measured in %.
Outcome measures
| Measure |
Investigational Group
n=1 Participants
Participants randomized to liraglutide will be started at a low dose (0.6 mg once per day) which will be gradually increased until 1.8 mg/day is reached for the 3-dose intervention and 3 mg/day is reached for the 5-dose intervention. Liraglutide will be administered by injection pen.
Liraglutide Pen Injector: Liraglutide will be provided using an injection pen provided by the manufacturer
|
Control Group
n=8 Participants
Participants in the control group will have placebo administered by injection pen following the same low dose titration to 3.0 mg once per day.
Placebo: Placebo injection pen
|
|---|---|---|
|
Percent Change in Body Weight
|
0.33 % change
Standard Deviation NA
Standard Deviation is not calculable for 1 participant
|
1.38 % change
Standard Deviation 2.39
|
SECONDARY outcome
Timeframe: From Day 2 to Day 19Population: In control group, n=1 could not obtain blood draw for measure. n=7 instead of n=8 reported.
Fructosamine is measured in umol/L
Outcome measures
| Measure |
Investigational Group
n=1 Participants
Participants randomized to liraglutide will be started at a low dose (0.6 mg once per day) which will be gradually increased until 1.8 mg/day is reached for the 3-dose intervention and 3 mg/day is reached for the 5-dose intervention. Liraglutide will be administered by injection pen.
Liraglutide Pen Injector: Liraglutide will be provided using an injection pen provided by the manufacturer
|
Control Group
n=7 Participants
Participants in the control group will have placebo administered by injection pen following the same low dose titration to 3.0 mg once per day.
Placebo: Placebo injection pen
|
|---|---|---|
|
Change in Fasting Blood Samples for Fructosamine
|
-14.00 umol/L
Standard Deviation NA
Standard Deviation is not calculable for 1 participant
|
2.71 umol/L
Standard Deviation 21.48
|
SECONDARY outcome
Timeframe: From Day 2 to Day 19HA1c is measured in %
Outcome measures
| Measure |
Investigational Group
n=1 Participants
Participants randomized to liraglutide will be started at a low dose (0.6 mg once per day) which will be gradually increased until 1.8 mg/day is reached for the 3-dose intervention and 3 mg/day is reached for the 5-dose intervention. Liraglutide will be administered by injection pen.
Liraglutide Pen Injector: Liraglutide will be provided using an injection pen provided by the manufacturer
|
Control Group
n=8 Participants
Participants in the control group will have placebo administered by injection pen following the same low dose titration to 3.0 mg once per day.
Placebo: Placebo injection pen
|
|---|---|---|
|
Change in Fasting Blood Samples for HA1c
|
-0.10 % of total hemoglobin in the blood
Standard Deviation NA
Standard Deviation is not calculable for 1 participant
|
0 % of total hemoglobin in the blood
Standard Deviation 0.11
|
SECONDARY outcome
Timeframe: Days 1-21 and at 30 days post-intervention (Day 49).Population: Randomized participants
Number of participants affected by probable drug-related adverse events.
Outcome measures
| Measure |
Investigational Group
n=12 Participants
Participants randomized to liraglutide will be started at a low dose (0.6 mg once per day) which will be gradually increased until 1.8 mg/day is reached for the 3-dose intervention and 3 mg/day is reached for the 5-dose intervention. Liraglutide will be administered by injection pen.
Liraglutide Pen Injector: Liraglutide will be provided using an injection pen provided by the manufacturer
|
Control Group
n=13 Participants
Participants in the control group will have placebo administered by injection pen following the same low dose titration to 3.0 mg once per day.
Placebo: Placebo injection pen
|
|---|---|---|
|
Frequency of Adverse Events (AE) and Serious Adverse Events (SAE)
Participants with drug-related AEs
|
5 Participants
|
3 Participants
|
|
Frequency of Adverse Events (AE) and Serious Adverse Events (SAE)
Participants with drug-related SAEs
|
1 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 1), end of the target drug dose (Day 19)Population: In placebo group, processing difficulties limited analysis. N=5 reported.
fNIRs indexes regional cerebral oxygenation saturation (%) by optical density (OD). Increased OD indicates increased blood oxygen saturation.
Outcome measures
| Measure |
Investigational Group
n=1 Participants
Participants randomized to liraglutide will be started at a low dose (0.6 mg once per day) which will be gradually increased until 1.8 mg/day is reached for the 3-dose intervention and 3 mg/day is reached for the 5-dose intervention. Liraglutide will be administered by injection pen.
Liraglutide Pen Injector: Liraglutide will be provided using an injection pen provided by the manufacturer
|
Control Group
n=5 Participants
Participants in the control group will have placebo administered by injection pen following the same low dose titration to 3.0 mg once per day.
Placebo: Placebo injection pen
|
|---|---|---|
|
Change in Blood Oxygenation Level Response to Visual Opioid Drug Cues in Prefrontal Cortex Using Functional Near Infrared Spectroscopy (fNIRs)
|
-3.10 Optical density (OD)
Standard Deviation NA
Standard Deviation is not calculable for 1 participant
|
-0.58 Optical density (OD)
Standard Deviation 0.65
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Treatment (averaged across Days 2-19), Rebound follow up (averaged across Days 20-21)Population: n=1 did not complete entire EMA. n=7 instead of n=8 reported.
Scores are measured on a 0-4 point VAS, where 0= no craving, 4= maximum craving. Treatment score is the average scores across Days 2-19. Rebound follow up score is the average scores across Days 20-21.
Outcome measures
| Measure |
Investigational Group
n=1 Participants
Participants randomized to liraglutide will be started at a low dose (0.6 mg once per day) which will be gradually increased until 1.8 mg/day is reached for the 3-dose intervention and 3 mg/day is reached for the 5-dose intervention. Liraglutide will be administered by injection pen.
Liraglutide Pen Injector: Liraglutide will be provided using an injection pen provided by the manufacturer
|
Control Group
n=7 Participants
Participants in the control group will have placebo administered by injection pen following the same low dose titration to 3.0 mg once per day.
Placebo: Placebo injection pen
|
|---|---|---|
|
Rebound Change in Ambient Drug Craving Over Time as Measured by Visual Analog Scale (VAS)
|
-0.11 score on a scale
Standard Deviation NA
Standard Deviation is not calculable for 1 participant
|
-0.15 score on a scale
Standard Deviation 0.47
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From end of the target drug dose (Day 19) to rebound follow up (Day 21).Blood pressure measurements in mmHg. Both pressures will be assessed during the study period.
Outcome measures
| Measure |
Investigational Group
n=1 Participants
Participants randomized to liraglutide will be started at a low dose (0.6 mg once per day) which will be gradually increased until 1.8 mg/day is reached for the 3-dose intervention and 3 mg/day is reached for the 5-dose intervention. Liraglutide will be administered by injection pen.
Liraglutide Pen Injector: Liraglutide will be provided using an injection pen provided by the manufacturer
|
Control Group
n=8 Participants
Participants in the control group will have placebo administered by injection pen following the same low dose titration to 3.0 mg once per day.
Placebo: Placebo injection pen
|
|---|---|---|
|
Rebound Change in Blood Pressure
Change in systolic pressure
|
11.00 mmHg
Standard Deviation NA
Standard Deviation is not calculable for 1 participant
|
-0.56 mmHg
Standard Deviation 12.45
|
|
Rebound Change in Blood Pressure
Change in diastolic pressure
|
10.25 mmHg
Standard Deviation NA
Standard Deviation is not calculable for 1 participant
|
-1.59 mmHg
Standard Deviation 6.27
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From end of the target drug dose (Day 19) to rebound follow up (Day 21).Heart rate measurements in beats per minute
Outcome measures
| Measure |
Investigational Group
n=1 Participants
Participants randomized to liraglutide will be started at a low dose (0.6 mg once per day) which will be gradually increased until 1.8 mg/day is reached for the 3-dose intervention and 3 mg/day is reached for the 5-dose intervention. Liraglutide will be administered by injection pen.
Liraglutide Pen Injector: Liraglutide will be provided using an injection pen provided by the manufacturer
|
Control Group
n=8 Participants
Participants in the control group will have placebo administered by injection pen following the same low dose titration to 3.0 mg once per day.
Placebo: Placebo injection pen
|
|---|---|---|
|
Rebound Change in Heart Rate
|
8.50 beats per minute
Standard Deviation NA
Standard Deviation is not calculable for 1 participant
|
-6.31 beats per minute
Standard Deviation 8.41
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From end of the target drug dose (Day 19) to rebound follow up (Day 21).Respiratory rate in breaths per minutes.
Outcome measures
| Measure |
Investigational Group
n=1 Participants
Participants randomized to liraglutide will be started at a low dose (0.6 mg once per day) which will be gradually increased until 1.8 mg/day is reached for the 3-dose intervention and 3 mg/day is reached for the 5-dose intervention. Liraglutide will be administered by injection pen.
Liraglutide Pen Injector: Liraglutide will be provided using an injection pen provided by the manufacturer
|
Control Group
n=8 Participants
Participants in the control group will have placebo administered by injection pen following the same low dose titration to 3.0 mg once per day.
Placebo: Placebo injection pen
|
|---|---|---|
|
Rebound Change in Respiratory Rate
|
-6.33 breaths per minute
Standard Deviation NA
Standard Deviation is not calculable for 1 participant
|
-0.67 breaths per minute
Standard Deviation 2.83
|
Adverse Events
Investigational Group
Serious events: 2 serious events
Other events: 10 other events
Deaths: 0 deaths
Control Group
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Investigational Group
n=12 participants at risk
Participants randomized to liraglutide will be started at a low dose (0.6 mg once per day) which will be gradually increased until 1.8 mg/day is reached for the 3-dose intervention and 3 mg/day is reached for the 5-dose intervention. Liraglutide will be administered by injection pen.
Liraglutide Pen Injector: Liraglutide will be provided using an injection pen provided by the manufacturer
|
Control Group
n=13 participants at risk
Participants in the control group will have placebo administered by injection pen following the same low dose titration to 3.0 mg once per day.
Placebo: Placebo injection pen
|
|---|---|---|
|
Vascular disorders
Vasovagal syncope
|
8.3%
1/12 • Number of events 1 • 54 days
Subjects were routinely questioned about adverse events and EMR reviewed by nursing and research staff Days 1-21. A follow-up communication was scheduled 30 days (±5 days) after the participant's last treatment day. Participants could be assessed up to 54 days for adverse events.
|
0.00%
0/13 • 54 days
Subjects were routinely questioned about adverse events and EMR reviewed by nursing and research staff Days 1-21. A follow-up communication was scheduled 30 days (±5 days) after the participant's last treatment day. Participants could be assessed up to 54 days for adverse events.
|
|
General disorders
Overdose to illicit drug
|
8.3%
1/12 • Number of events 1 • 54 days
Subjects were routinely questioned about adverse events and EMR reviewed by nursing and research staff Days 1-21. A follow-up communication was scheduled 30 days (±5 days) after the participant's last treatment day. Participants could be assessed up to 54 days for adverse events.
|
7.7%
1/13 • Number of events 1 • 54 days
Subjects were routinely questioned about adverse events and EMR reviewed by nursing and research staff Days 1-21. A follow-up communication was scheduled 30 days (±5 days) after the participant's last treatment day. Participants could be assessed up to 54 days for adverse events.
|
Other adverse events
| Measure |
Investigational Group
n=12 participants at risk
Participants randomized to liraglutide will be started at a low dose (0.6 mg once per day) which will be gradually increased until 1.8 mg/day is reached for the 3-dose intervention and 3 mg/day is reached for the 5-dose intervention. Liraglutide will be administered by injection pen.
Liraglutide Pen Injector: Liraglutide will be provided using an injection pen provided by the manufacturer
|
Control Group
n=13 participants at risk
Participants in the control group will have placebo administered by injection pen following the same low dose titration to 3.0 mg once per day.
Placebo: Placebo injection pen
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
33.3%
4/12 • Number of events 6 • 54 days
Subjects were routinely questioned about adverse events and EMR reviewed by nursing and research staff Days 1-21. A follow-up communication was scheduled 30 days (±5 days) after the participant's last treatment day. Participants could be assessed up to 54 days for adverse events.
|
23.1%
3/13 • Number of events 3 • 54 days
Subjects were routinely questioned about adverse events and EMR reviewed by nursing and research staff Days 1-21. A follow-up communication was scheduled 30 days (±5 days) after the participant's last treatment day. Participants could be assessed up to 54 days for adverse events.
|
|
Gastrointestinal disorders
Constipation
|
16.7%
2/12 • Number of events 2 • 54 days
Subjects were routinely questioned about adverse events and EMR reviewed by nursing and research staff Days 1-21. A follow-up communication was scheduled 30 days (±5 days) after the participant's last treatment day. Participants could be assessed up to 54 days for adverse events.
|
15.4%
2/13 • Number of events 2 • 54 days
Subjects were routinely questioned about adverse events and EMR reviewed by nursing and research staff Days 1-21. A follow-up communication was scheduled 30 days (±5 days) after the participant's last treatment day. Participants could be assessed up to 54 days for adverse events.
|
|
Gastrointestinal disorders
GI/abdominal upset
|
25.0%
3/12 • Number of events 3 • 54 days
Subjects were routinely questioned about adverse events and EMR reviewed by nursing and research staff Days 1-21. A follow-up communication was scheduled 30 days (±5 days) after the participant's last treatment day. Participants could be assessed up to 54 days for adverse events.
|
7.7%
1/13 • Number of events 1 • 54 days
Subjects were routinely questioned about adverse events and EMR reviewed by nursing and research staff Days 1-21. A follow-up communication was scheduled 30 days (±5 days) after the participant's last treatment day. Participants could be assessed up to 54 days for adverse events.
|
|
Gastrointestinal disorders
Decreased appetite
|
8.3%
1/12 • Number of events 2 • 54 days
Subjects were routinely questioned about adverse events and EMR reviewed by nursing and research staff Days 1-21. A follow-up communication was scheduled 30 days (±5 days) after the participant's last treatment day. Participants could be assessed up to 54 days for adverse events.
|
0.00%
0/13 • 54 days
Subjects were routinely questioned about adverse events and EMR reviewed by nursing and research staff Days 1-21. A follow-up communication was scheduled 30 days (±5 days) after the participant's last treatment day. Participants could be assessed up to 54 days for adverse events.
|
|
General disorders
Headache
|
25.0%
3/12 • Number of events 4 • 54 days
Subjects were routinely questioned about adverse events and EMR reviewed by nursing and research staff Days 1-21. A follow-up communication was scheduled 30 days (±5 days) after the participant's last treatment day. Participants could be assessed up to 54 days for adverse events.
|
0.00%
0/13 • 54 days
Subjects were routinely questioned about adverse events and EMR reviewed by nursing and research staff Days 1-21. A follow-up communication was scheduled 30 days (±5 days) after the participant's last treatment day. Participants could be assessed up to 54 days for adverse events.
|
|
General disorders
Fatigue
|
8.3%
1/12 • Number of events 1 • 54 days
Subjects were routinely questioned about adverse events and EMR reviewed by nursing and research staff Days 1-21. A follow-up communication was scheduled 30 days (±5 days) after the participant's last treatment day. Participants could be assessed up to 54 days for adverse events.
|
7.7%
1/13 • Number of events 2 • 54 days
Subjects were routinely questioned about adverse events and EMR reviewed by nursing and research staff Days 1-21. A follow-up communication was scheduled 30 days (±5 days) after the participant's last treatment day. Participants could be assessed up to 54 days for adverse events.
|
|
General disorders
Hiccups
|
0.00%
0/12 • 54 days
Subjects were routinely questioned about adverse events and EMR reviewed by nursing and research staff Days 1-21. A follow-up communication was scheduled 30 days (±5 days) after the participant's last treatment day. Participants could be assessed up to 54 days for adverse events.
|
7.7%
1/13 • Number of events 1 • 54 days
Subjects were routinely questioned about adverse events and EMR reviewed by nursing and research staff Days 1-21. A follow-up communication was scheduled 30 days (±5 days) after the participant's last treatment day. Participants could be assessed up to 54 days for adverse events.
|
|
General disorders
Continuing opioid withdrawal
|
0.00%
0/12 • 54 days
Subjects were routinely questioned about adverse events and EMR reviewed by nursing and research staff Days 1-21. A follow-up communication was scheduled 30 days (±5 days) after the participant's last treatment day. Participants could be assessed up to 54 days for adverse events.
|
7.7%
1/13 • Number of events 1 • 54 days
Subjects were routinely questioned about adverse events and EMR reviewed by nursing and research staff Days 1-21. A follow-up communication was scheduled 30 days (±5 days) after the participant's last treatment day. Participants could be assessed up to 54 days for adverse events.
|
|
General disorders
Light headed
|
8.3%
1/12 • Number of events 1 • 54 days
Subjects were routinely questioned about adverse events and EMR reviewed by nursing and research staff Days 1-21. A follow-up communication was scheduled 30 days (±5 days) after the participant's last treatment day. Participants could be assessed up to 54 days for adverse events.
|
0.00%
0/13 • 54 days
Subjects were routinely questioned about adverse events and EMR reviewed by nursing and research staff Days 1-21. A follow-up communication was scheduled 30 days (±5 days) after the participant's last treatment day. Participants could be assessed up to 54 days for adverse events.
|
|
General disorders
Ringing sensation
|
0.00%
0/12 • 54 days
Subjects were routinely questioned about adverse events and EMR reviewed by nursing and research staff Days 1-21. A follow-up communication was scheduled 30 days (±5 days) after the participant's last treatment day. Participants could be assessed up to 54 days for adverse events.
|
7.7%
1/13 • Number of events 1 • 54 days
Subjects were routinely questioned about adverse events and EMR reviewed by nursing and research staff Days 1-21. A follow-up communication was scheduled 30 days (±5 days) after the participant's last treatment day. Participants could be assessed up to 54 days for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Knee pain
|
0.00%
0/12 • 54 days
Subjects were routinely questioned about adverse events and EMR reviewed by nursing and research staff Days 1-21. A follow-up communication was scheduled 30 days (±5 days) after the participant's last treatment day. Participants could be assessed up to 54 days for adverse events.
|
7.7%
1/13 • Number of events 1 • 54 days
Subjects were routinely questioned about adverse events and EMR reviewed by nursing and research staff Days 1-21. A follow-up communication was scheduled 30 days (±5 days) after the participant's last treatment day. Participants could be assessed up to 54 days for adverse events.
|
|
Musculoskeletal and connective tissue disorders
Discomfort at Dexcom sensor site
|
0.00%
0/12 • 54 days
Subjects were routinely questioned about adverse events and EMR reviewed by nursing and research staff Days 1-21. A follow-up communication was scheduled 30 days (±5 days) after the participant's last treatment day. Participants could be assessed up to 54 days for adverse events.
|
7.7%
1/13 • Number of events 2 • 54 days
Subjects were routinely questioned about adverse events and EMR reviewed by nursing and research staff Days 1-21. A follow-up communication was scheduled 30 days (±5 days) after the participant's last treatment day. Participants could be assessed up to 54 days for adverse events.
|
|
Metabolism and nutrition disorders
Shakiness, diaphoresis, and tremor
|
8.3%
1/12 • Number of events 1 • 54 days
Subjects were routinely questioned about adverse events and EMR reviewed by nursing and research staff Days 1-21. A follow-up communication was scheduled 30 days (±5 days) after the participant's last treatment day. Participants could be assessed up to 54 days for adverse events.
|
7.7%
1/13 • Number of events 1 • 54 days
Subjects were routinely questioned about adverse events and EMR reviewed by nursing and research staff Days 1-21. A follow-up communication was scheduled 30 days (±5 days) after the participant's last treatment day. Participants could be assessed up to 54 days for adverse events.
|
|
Psychiatric disorders
Night terrors
|
8.3%
1/12 • Number of events 1 • 54 days
Subjects were routinely questioned about adverse events and EMR reviewed by nursing and research staff Days 1-21. A follow-up communication was scheduled 30 days (±5 days) after the participant's last treatment day. Participants could be assessed up to 54 days for adverse events.
|
0.00%
0/13 • 54 days
Subjects were routinely questioned about adverse events and EMR reviewed by nursing and research staff Days 1-21. A follow-up communication was scheduled 30 days (±5 days) after the participant's last treatment day. Participants could be assessed up to 54 days for adverse events.
|
|
Psychiatric disorders
Intrusive thoughts or images
|
8.3%
1/12 • Number of events 1 • 54 days
Subjects were routinely questioned about adverse events and EMR reviewed by nursing and research staff Days 1-21. A follow-up communication was scheduled 30 days (±5 days) after the participant's last treatment day. Participants could be assessed up to 54 days for adverse events.
|
0.00%
0/13 • 54 days
Subjects were routinely questioned about adverse events and EMR reviewed by nursing and research staff Days 1-21. A follow-up communication was scheduled 30 days (±5 days) after the participant's last treatment day. Participants could be assessed up to 54 days for adverse events.
|
|
Skin and subcutaneous tissue disorders
Bleeding under Dexcom sensor
|
8.3%
1/12 • Number of events 1 • 54 days
Subjects were routinely questioned about adverse events and EMR reviewed by nursing and research staff Days 1-21. A follow-up communication was scheduled 30 days (±5 days) after the participant's last treatment day. Participants could be assessed up to 54 days for adverse events.
|
0.00%
0/13 • 54 days
Subjects were routinely questioned about adverse events and EMR reviewed by nursing and research staff Days 1-21. A follow-up communication was scheduled 30 days (±5 days) after the participant's last treatment day. Participants could be assessed up to 54 days for adverse events.
|
|
Skin and subcutaneous tissue disorders
Bruising at injection site
|
0.00%
0/12 • 54 days
Subjects were routinely questioned about adverse events and EMR reviewed by nursing and research staff Days 1-21. A follow-up communication was scheduled 30 days (±5 days) after the participant's last treatment day. Participants could be assessed up to 54 days for adverse events.
|
7.7%
1/13 • Number of events 1 • 54 days
Subjects were routinely questioned about adverse events and EMR reviewed by nursing and research staff Days 1-21. A follow-up communication was scheduled 30 days (±5 days) after the participant's last treatment day. Participants could be assessed up to 54 days for adverse events.
|
|
Skin and subcutaneous tissue disorders
Skin irritation spots
|
8.3%
1/12 • Number of events 1 • 54 days
Subjects were routinely questioned about adverse events and EMR reviewed by nursing and research staff Days 1-21. A follow-up communication was scheduled 30 days (±5 days) after the participant's last treatment day. Participants could be assessed up to 54 days for adverse events.
|
7.7%
1/13 • Number of events 1 • 54 days
Subjects were routinely questioned about adverse events and EMR reviewed by nursing and research staff Days 1-21. A follow-up communication was scheduled 30 days (±5 days) after the participant's last treatment day. Participants could be assessed up to 54 days for adverse events.
|
|
Skin and subcutaneous tissue disorders
Insect bite
|
0.00%
0/12 • 54 days
Subjects were routinely questioned about adverse events and EMR reviewed by nursing and research staff Days 1-21. A follow-up communication was scheduled 30 days (±5 days) after the participant's last treatment day. Participants could be assessed up to 54 days for adverse events.
|
7.7%
1/13 • Number of events 2 • 54 days
Subjects were routinely questioned about adverse events and EMR reviewed by nursing and research staff Days 1-21. A follow-up communication was scheduled 30 days (±5 days) after the participant's last treatment day. Participants could be assessed up to 54 days for adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place