Trial Outcomes & Findings for Low Level Laser Treatment (LLLT) and Lorcaserin for Weight Management (NCT NCT02129608)
NCT ID: NCT02129608
Last Updated: 2016-11-22
Results Overview
The change in waist circumference from baseline to 3 months
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
44 participants
Primary outcome timeframe
3 months
Results posted on
2016-11-22
Participant Flow
Participant milestones
| Measure |
LLLT
Low Level Laser Therapy (LLLT) once a week for 12 weeks
LLLT: The LLLT uses 6 diode laser heads - each emitting 17 mW output. Subject will receive 30 minutes of therapy in the frontal central area and 30 minutes of therapy in the back central area, once a week for 12 weeks.
|
Lorcaserin
locarserin monotherapy - 10 mg, twice daily for 12 weeks
Lorcaserin: 10 mg pills twice daily for 12 weeks.
|
LLLT and Lorcaserin
LLLT once a week for 12 weeks and 10 mg of Lorcaserin twice daily for 12 weeks
LLLT: The LLLT uses 6 diode laser heads - each emitting 17 mW output. Subject will receive 30 minutes of therapy in the frontal central area and 30 minutes of therapy in the back central area, once a week for 12 weeks.
Lorcaserin: 10 mg pills twice daily for 12 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
15
|
14
|
15
|
|
Overall Study
End of Treatment
|
15
|
13
|
12
|
|
Overall Study
COMPLETED
|
15
|
13
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
3
|
Reasons for withdrawal
| Measure |
LLLT
Low Level Laser Therapy (LLLT) once a week for 12 weeks
LLLT: The LLLT uses 6 diode laser heads - each emitting 17 mW output. Subject will receive 30 minutes of therapy in the frontal central area and 30 minutes of therapy in the back central area, once a week for 12 weeks.
|
Lorcaserin
locarserin monotherapy - 10 mg, twice daily for 12 weeks
Lorcaserin: 10 mg pills twice daily for 12 weeks.
|
LLLT and Lorcaserin
LLLT once a week for 12 weeks and 10 mg of Lorcaserin twice daily for 12 weeks
LLLT: The LLLT uses 6 diode laser heads - each emitting 17 mW output. Subject will receive 30 minutes of therapy in the frontal central area and 30 minutes of therapy in the back central area, once a week for 12 weeks.
Lorcaserin: 10 mg pills twice daily for 12 weeks.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
2
|
Baseline Characteristics
Low Level Laser Treatment (LLLT) and Lorcaserin for Weight Management
Baseline characteristics by cohort
| Measure |
LLLT
n=15 Participants
Low Level Laser Therapy (LLLT) once a week for 12 weeks
LLLT: The LLLT uses 6 diode laser heads - each emitting 17 mW output. Subject will receive 30 minutes of therapy in the frontal central area and 30 minutes of therapy in the back central area, once a week for 12 weeks.
|
Lorcaserin
n=14 Participants
locarserin monotherapy - 10 mg, twice daily for 12 weeks
Lorcaserin: 10 mg pills twice daily for 12 weeks.
|
LLLT and Lorcaserin
n=15 Participants
LLLT once a week for 12 weeks and 10 mg of Lorcaserin twice daily for 12 weeks
LLLT: The LLLT uses 6 diode laser heads - each emitting 17 mW output. Subject will receive 30 minutes of therapy in the frontal central area and 30 minutes of therapy in the back central area, once a week for 12 weeks.
Lorcaserin: 10 mg pills twice daily for 12 weeks.
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Continuous
|
45.4 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
40.6 years
STANDARD_DEVIATION 11.5 • n=7 Participants
|
45.4 years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
43.9 years
STANDARD_DEVIATION 11.6 • n=4 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
14 participants
n=7 Participants
|
15 participants
n=5 Participants
|
44 participants
n=4 Participants
|
|
Weight (in kgs)
|
96.0 kg
STANDARD_DEVIATION 15.3 • n=5 Participants
|
94.4 kg
STANDARD_DEVIATION 16.2 • n=7 Participants
|
90.3 kg
STANDARD_DEVIATION 14.0 • n=5 Participants
|
93.5 kg
STANDARD_DEVIATION 15.0 • n=4 Participants
|
|
waist circumference (in cm)
|
105.3 cm
STANDARD_DEVIATION 11.6 • n=5 Participants
|
108.0 cm
STANDARD_DEVIATION 15.7 • n=7 Participants
|
100.9 cm
STANDARD_DEVIATION 10.0 • n=5 Participants
|
104.7 cm
STANDARD_DEVIATION 12.6 • n=4 Participants
|
PRIMARY outcome
Timeframe: 3 monthsThe change in waist circumference from baseline to 3 months
Outcome measures
| Measure |
LLLT
n=15 Participants
Low Level Laser Therapy (LLLT) once a week for 12 weeks
LLLT: The LLLT uses 6 diode laser heads - each emitting 17 mW output. Subject will receive 30 minutes of therapy in the frontal central area and 30 minutes of therapy in the back central area, once a week for 12 weeks.
|
Lorcaserin
n=14 Participants
locarserin monotherapy - 10 mg, twice daily for 12 weeks
Lorcaserin: 10 mg pills twice daily for 12 weeks.
|
LLLT and Lorcaserin
n=15 Participants
LLLT once a week for 12 weeks and 10 mg of Lorcaserin twice daily for 12 weeks
LLLT: The LLLT uses 6 diode laser heads - each emitting 17 mW output. Subject will receive 30 minutes of therapy in the frontal central area and 30 minutes of therapy in the back central area, once a week for 12 weeks.
Lorcaserin: 10 mg pills twice daily for 12 weeks.
|
|---|---|---|---|
|
Change in Waist Circumference
|
-2.3 cm
Standard Deviation 4.1
|
-6.0 cm
Standard Deviation 7.3
|
-4.0 cm
Standard Deviation 5.5
|
PRIMARY outcome
Timeframe: 3 monthsThe change in weight from baseline to 3 months
Outcome measures
| Measure |
LLLT
n=15 Participants
Low Level Laser Therapy (LLLT) once a week for 12 weeks
LLLT: The LLLT uses 6 diode laser heads - each emitting 17 mW output. Subject will receive 30 minutes of therapy in the frontal central area and 30 minutes of therapy in the back central area, once a week for 12 weeks.
|
Lorcaserin
n=14 Participants
locarserin monotherapy - 10 mg, twice daily for 12 weeks
Lorcaserin: 10 mg pills twice daily for 12 weeks.
|
LLLT and Lorcaserin
n=15 Participants
LLLT once a week for 12 weeks and 10 mg of Lorcaserin twice daily for 12 weeks
LLLT: The LLLT uses 6 diode laser heads - each emitting 17 mW output. Subject will receive 30 minutes of therapy in the frontal central area and 30 minutes of therapy in the back central area, once a week for 12 weeks.
Lorcaserin: 10 mg pills twice daily for 12 weeks.
|
|---|---|---|---|
|
Change in Weight
|
-1.0 kg
Standard Deviation 4.4
|
-3.7 kg
Standard Deviation 3.3
|
-3.5 kg
Standard Deviation 3.6
|
Adverse Events
LLLT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Lorcaserin
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
LLLT and Lorcaserin
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LLLT
n=15 participants at risk
Low Level Laser Therapy (LLLT) once a week for 12 weeks
LLLT: The LLLT uses 6 diode laser heads - each emitting 17 mW output. Subject will receive 30 minutes of therapy in the frontal central area and 30 minutes of therapy in the back central area, once a week for 12 weeks.
|
Lorcaserin
n=14 participants at risk
locarserin monotherapy - 10 mg, twice daily for 12 weeks
Lorcaserin: 10 mg pills twice daily for 12 weeks.
|
LLLT and Lorcaserin
n=15 participants at risk
LLLT once a week for 12 weeks and 10 mg of Lorcaserin twice daily for 12 weeks
LLLT: The LLLT uses 6 diode laser heads - each emitting 17 mW output. Subject will receive 30 minutes of therapy in the frontal central area and 30 minutes of therapy in the back central area, once a week for 12 weeks.
Lorcaserin: 10 mg pills twice daily for 12 weeks.
|
|---|---|---|---|
|
General disorders
dizziness
|
0.00%
0/15
|
7.1%
1/14 • Number of events 1
|
6.7%
1/15 • Number of events 1
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/15
|
7.1%
1/14 • Number of events 1
|
13.3%
2/15 • Number of events 2
|
|
Nervous system disorders
Headache
|
0.00%
0/15
|
7.1%
1/14 • Number of events 1
|
13.3%
2/15 • Number of events 2
|
|
General disorders
Low Blood Pressure
|
0.00%
0/15
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
|
General disorders
Tingling
|
0.00%
0/15
|
0.00%
0/14
|
6.7%
1/15 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place