Trial Outcomes & Findings for SMART Use of Medication for the Treatment of Adolescent Severe Obesity (NCT NCT04007393)
NCT ID: NCT04007393
Last Updated: 2026-05-05
Results Overview
The outcome values represent percent change in BMI from baseline to week 48.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
150 participants
Primary outcome timeframe
Baseline to Week 48
Results posted on
2026-05-05
Participant Flow
Participants were recruited in the Pediatric Weight Management Clinic, by flyers and recruitment letters.
Lifestyle Modification Therapy (LSMT): LSMT will consist of both in-person and telephone sessions delivered throughout the entirety of the 48-week intervention. Sessions will last 30-60 minutes. Phentermine Pill: Subjects will take 15 mg of phentermine every morning for 12 weeks. Topiramate Pill: Topiramate dosing will begin at 50 mg every morning for the first 7 days, and then increase to 100 mg every morning through week 48.
Participant milestones
| Measure |
Arm 1: LSMT 12
Participants in this arm will start LSMT at baseline and have a weight loss response assessment at 12 weeks: if body mass index (BMI) is down 5% at 12 weeks, the participant will continue with LSMT for the remainder of the study.
|
Arm 1: LSMT 12 + Phentermine
Participants in this arm will start LSMT at baseline and have a weight loss response assessment at 12 weeks: if BMI is not down 5% at 12 weeks, the participant will add phentermine to LSMT (phentermine+LSMT) and undergo a second weight loss response assessment after 12 weeks of phentermine+LSMT; i.e. at 24 weeks.
|
Arm 1: LSMT 12+Phentermine+Topiramate
Participants in this arm will start LSMT at baseline and have a weight loss response assessment at 12 weeks: if body mass index (BMI) is down 5% at 12 weeks, the participant will continue with LSMT for the remainder of the study; if BMI is not down 5% at 12 weeks, the participant will add phentermine to LSMT (phentermine+LSMT) and undergo a second weight loss response assessment after 12 weeks of phentermine+LSMT; i.e. at 24 weeks. At 24 weeks, if BMI is not down by 5% at 24 weeks, the participant will be randomized to topiramate+phentermine+LSMT or topiramate+placebo+LSMT for the remainder of the study.
|
Arm 1: LSMT 12+ Topiramate + Placebo
Participants in this arm will start LSMT at baseline and have a weight loss response assessment at 12 weeks: if body mass index (BMI) is down 5% at 12 weeks, the participant will continue with LSMT for the remainder of the study; if BMI is not down 5% at 12 weeks, the participant will add phentermine to LSMT (phentermine+LSMT) and undergo a second weight loss response assessment after 12 weeks of phentermine+LSMT; i.e. at 24 weeks. At 24 weeks, if BMI is not down by 5% at 24 weeks, the participant will be randomized to topiramate+placebo+LSMT for the remainder of the study.
|
Arm 2: LSMT 24
Participants in this arm will start LSMT at baseline and have a weight loss response assessment at 24 weeks: if body mass index (BMI) is down 5% at 24 weeks, the participant will continue with LSMT for the remainder of the study (i.e. for another 24 weeks)
|
Arm 2: LSMT 24 + Phentermine
Participants in this arm will start LSMT at baseline and have a weight loss response assessment at 24 weeks: if BMI is not down 5% at 24 weeks, the participant will add phentermine to LSMT (phentermine+LSMT) and undergo a second weight loss response assessment after 12 weeks of phentermine+LSMT.
|
Arm 2: LSMT 24+Phentermine+Topiramate
Participants in this arm will start LSMT at baseline and have a weight loss response assessment at 24 weeks: if BMI is not down 5% at 24 weeks, the participant will add phentermine to LSMT (phentermine+LSMT) and undergo a second weight loss response assessment after 12 weeks of phentermine+LSMT. At 36 weeks, if BMI is not down by 5% at 36 weeks, the participant will be randomized to topiramate+phentermine+LSMT for the duration of the study
|
Arm 2: LSMT+Topiramate+Placebo
Participants in this arm will start LSMT at baseline and have a weight loss response assessment at 24 weeks: if BMI is not down 5% at 24 weeks, the participant will add phentermine to LSMT (phentermine+LSMT) and undergo a second weight loss response assessment after 12 weeks of phentermine+LSMT. At 36 weeks, if BMI is not down by 5% at 36 weeks, the participant will be randomized to topiramate+phentermine+LSMT or topiramate+placebo+LSMT for the remainder of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
24
|
20
|
21
|
16
|
19
|
20
|
19
|
|
Overall Study
COMPLETED
|
11
|
24
|
19
|
20
|
11
|
17
|
20
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
1
|
5
|
2
|
0
|
0
|
Reasons for withdrawal
| Measure |
Arm 1: LSMT 12
Participants in this arm will start LSMT at baseline and have a weight loss response assessment at 12 weeks: if body mass index (BMI) is down 5% at 12 weeks, the participant will continue with LSMT for the remainder of the study.
|
Arm 1: LSMT 12 + Phentermine
Participants in this arm will start LSMT at baseline and have a weight loss response assessment at 12 weeks: if BMI is not down 5% at 12 weeks, the participant will add phentermine to LSMT (phentermine+LSMT) and undergo a second weight loss response assessment after 12 weeks of phentermine+LSMT; i.e. at 24 weeks.
|
Arm 1: LSMT 12+Phentermine+Topiramate
Participants in this arm will start LSMT at baseline and have a weight loss response assessment at 12 weeks: if body mass index (BMI) is down 5% at 12 weeks, the participant will continue with LSMT for the remainder of the study; if BMI is not down 5% at 12 weeks, the participant will add phentermine to LSMT (phentermine+LSMT) and undergo a second weight loss response assessment after 12 weeks of phentermine+LSMT; i.e. at 24 weeks. At 24 weeks, if BMI is not down by 5% at 24 weeks, the participant will be randomized to topiramate+phentermine+LSMT or topiramate+placebo+LSMT for the remainder of the study.
|
Arm 1: LSMT 12+ Topiramate + Placebo
Participants in this arm will start LSMT at baseline and have a weight loss response assessment at 12 weeks: if body mass index (BMI) is down 5% at 12 weeks, the participant will continue with LSMT for the remainder of the study; if BMI is not down 5% at 12 weeks, the participant will add phentermine to LSMT (phentermine+LSMT) and undergo a second weight loss response assessment after 12 weeks of phentermine+LSMT; i.e. at 24 weeks. At 24 weeks, if BMI is not down by 5% at 24 weeks, the participant will be randomized to topiramate+placebo+LSMT for the remainder of the study.
|
Arm 2: LSMT 24
Participants in this arm will start LSMT at baseline and have a weight loss response assessment at 24 weeks: if body mass index (BMI) is down 5% at 24 weeks, the participant will continue with LSMT for the remainder of the study (i.e. for another 24 weeks)
|
Arm 2: LSMT 24 + Phentermine
Participants in this arm will start LSMT at baseline and have a weight loss response assessment at 24 weeks: if BMI is not down 5% at 24 weeks, the participant will add phentermine to LSMT (phentermine+LSMT) and undergo a second weight loss response assessment after 12 weeks of phentermine+LSMT.
|
Arm 2: LSMT 24+Phentermine+Topiramate
Participants in this arm will start LSMT at baseline and have a weight loss response assessment at 24 weeks: if BMI is not down 5% at 24 weeks, the participant will add phentermine to LSMT (phentermine+LSMT) and undergo a second weight loss response assessment after 12 weeks of phentermine+LSMT. At 36 weeks, if BMI is not down by 5% at 36 weeks, the participant will be randomized to topiramate+phentermine+LSMT for the duration of the study
|
Arm 2: LSMT+Topiramate+Placebo
Participants in this arm will start LSMT at baseline and have a weight loss response assessment at 24 weeks: if BMI is not down 5% at 24 weeks, the participant will add phentermine to LSMT (phentermine+LSMT) and undergo a second weight loss response assessment after 12 weeks of phentermine+LSMT. At 36 weeks, if BMI is not down by 5% at 36 weeks, the participant will be randomized to topiramate+phentermine+LSMT or topiramate+placebo+LSMT for the remainder of the study.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
2
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
2
|
1
|
0
|
0
|
Baseline Characteristics
SMART Use of Medication for the Treatment of Adolescent Severe Obesity
Baseline characteristics by cohort
| Measure |
Arm 1: LSMT 12
n=11 Participants
Participants in this arm will start LSMT at baseline and have a weight loss response assessment at 12 weeks: if body mass index (BMI) is down 5% at 12 weeks, the participant will continue with LSMT for the remainder of the study
Lifestyle Modification Therapy (LSMT): LSMT will consist of both in-person and by telephone sessions delivered throughout the entirety of the 48-week intervention phase. Sessions will last 30-60 minutes.
|
Arm 1: LSMT 12+Phentermine
n=24 Participants
Participants in this arm will start LSMT at baseline and have a weight loss response assessment at 12 weeks: if body mass index (BMI) is not down 5% at 12 weeks, the participant will add phentermine to LSMT (phentermine+LSMT) and undergo a second weight loss response assessment after 12 weeks of phentermine+LSMT.
Lifestyle Modification Therapy (LSMT): LSMT will consist of both in-person and by telephone sessions delivered throughout the entirety of the 48-week intervention phase. Sessions will last 30-60 minutes.
Phentermine Pill: Subjects will take 15 mg of phentermine every morning for 12 weeks at which time there will be an assessment of weight loss. Subjects who achieve 5% or more BMI reduction after 12 weeks will continue 15 mg every morning for the remainder of the study along with their LSMT.
|
Arm 1: LSMT 12+Phentermine+Topiramate
n=20 Participants
If BMI is not down by 5% at 24 weeks, the participant will be randomized to topiramate+phentermine+LSMT or topiramate+placebo+LSMT for the remainder of the study.
Lifestyle Modification Therapy (LSMT): LSMT will consist of both in-person and by telephone sessions delivered throughout the entirety of the 48-week intervention phase. Sessions will last 30-60 minutes.
Phentermine Pill: Subjects will take 15 mg of phentermine every morning for 12 weeks at which time there will be an assessment of weight loss. Subjects who achieve 5% or more BMI reduction after 12 weeks will continue 15 mg every morning for the remainder of the study along with their LSMT.
Topiramate Pill: Topiramate dosing will begin at 50 mg every morning for the first 7 days, and then increase to 100 mg every morning through week 48. At the end of week 48 the taper off will be 50 mg every morning for 7 days and then discontinue.
|
Arm 1: LSMT+Topiramate+Placebo
n=21 Participants
Participants in this arm will start LSMT at baseline and have a weight loss response assessment at 24 weeks: if body mass index (BMI) is down 5% at 24 weeks, the participant will continue with LSMT for the remainder of the study; if BMI is not down 5% at 24 weeks, the participant will add phentermine to LSMT (phentermine+LSMT) and undergo a second weight loss response assessment after 12 weeks of phentermine+LSMT. At 24 weeks, if BMI is down 5% with phentermine+LSMT, the participant will continue with phentermine+LSMT for the the remainder of study; if BMI is not down by 5% at 24 weeks, the participant will be randomized to topiramate+phentermine+LSMT or topiramate+placebo+LSMT for the remainder of the study.
Lifestyle Modification Therapy (LSMT): LSMT will consist of both in-person and by telephone sessions delivered throughout the entirety of the 48-week intervention phase. Sessions will last 30-60 minutes.
Topiramate Pill: Topiramate dosing will begin at 50 mg every morning for the first 7 days, and then increase to 100 mg every morning through week 48. At the end of week 48 the taper off will be 50 mg every morning for 7 days and then discontinue.
|
Arm 2: LSMT 24
n=16 Participants
Participants in this arm will start LSMT at baseline and have a weight loss response assessment at 24 weeks: if body mass index (BMI) is down 5% at 24 weeks, the participant will continue with LSMT for the remainder of the study.
Lifestyle Modification Therapy (LSMT): LSMT will consist of both in-person and by telephone sessions delivered throughout the entirety of the 48-week intervention phase. Sessions will last 30-60 minutes.
|
Arm 2: LSMT 24+Phentermine
n=19 Participants
Participants in this arm will start LSMT at baseline and have a weight loss response assessment at 24 weeks: if body mass index (BMI) is not down 5% at 24 weeks, the participant will add phentermine to LSMT (phentermine+LSMT) and undergo a second weight loss response assessment after 12 weeks of phentermine+LSMT.
Lifestyle Modification Therapy (LSMT): LSMT will consist of both in-person and by telephone sessions delivered throughout the entirety of the 48-week intervention phase. Sessions will last 30-60 minutes.
Phentermine Pill: Subjects will take 15 mg of phentermine every morning for 12 weeks at which time there will be an assessment of weight loss. Subjects who achieve 5% or more BMI reduction after 12 weeks will continue 15 mg every morning for the remainder of the study along with their LSMT.
|
Arm 2: LSMT 24+Phentermine+Topiramate
n=20 Participants
Participants in this arm will start LSMT at baseline and have a weight loss response assessment at 24 weeks: when BMI is not down 5% at 24 weeks, the participant will add phentermine to LSMT (phentermine+LSMT) and undergo a second weight loss response assessment after 12 weeks of phentermine+LSMT. If BMI is not down by 5% at 24 weeks, the participant will be randomized to topiramate+phentermine+LSMT or topiramate+placebo+LSMT for the remainder of the study.
Lifestyle Modification Therapy (LSMT): LSMT will consist of both in-person and by telephone sessions delivered throughout the entirety of the 48-week intervention phase. Sessions will last 30-60 minutes.
Phentermine Pill: Subjects will take 15 mg of phentermine every morning for 12 weeks at which time there will be an assessment of weight loss. Subjects who achieve 5% or more BMI reduction after 12 weeks will continue 15 mg every morning for the remainder of the study along with their LSMT.
Topiramate Pill: Topiramate dosing will begin at 50 mg every morning for the first 7 days, and then increase to 100 mg every morning through week 48. At the end of week 48 the taper off will be 50 mg every morning for 7 days and then discontinue.
|
Arm 2: LSMT 24+Topiramate+Placebo
n=19 Participants
Participants in this arm will start LSMT at baseline and have a weight loss response assessment at 24 weeks: when BMI is not down 5% at 24 weeks, the participant will add phentermine to LSMT (phentermine+LSMT) and undergo a second weight loss response assessment after 12 weeks of phentermine+LSMT. If BMI is not down by 5% at 24 weeks, the participant will be randomized to topiramate+phentermine+LSMT or topiramate+placebo+LSMT for the remainder of the study.
Lifestyle Modification Therapy (LSMT): LSMT will consist of both in-person and by telephone sessions delivered throughout the entirety of the 48-week intervention phase. Sessions will last 30-60 minutes.
Topiramate Pill: Topiramate dosing will begin at 50 mg every morning for the first 7 days, and then increase to 100 mg every morning through week 48. At the end of week 48 the taper off will be 50 mg every morning for 7 days and then discontinue.
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
11 Participants
n=54 Participants
|
24 Participants
n=60 Participants
|
20 Participants
n=114 Participants
|
21 Participants
n=37 Participants
|
16 Participants
n=24 Participants
|
19 Participants
n=19 Participants
|
20 Participants
n=88 Participants
|
19 Participants
n=6 Participants
|
150 Participants
n=15 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=88 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=15 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=88 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=15 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=54 Participants
|
18 Participants
n=60 Participants
|
12 Participants
n=114 Participants
|
15 Participants
n=37 Participants
|
6 Participants
n=24 Participants
|
11 Participants
n=19 Participants
|
9 Participants
n=88 Participants
|
13 Participants
n=6 Participants
|
90 Participants
n=15 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=54 Participants
|
6 Participants
n=60 Participants
|
8 Participants
n=114 Participants
|
6 Participants
n=37 Participants
|
10 Participants
n=24 Participants
|
8 Participants
n=19 Participants
|
11 Participants
n=88 Participants
|
6 Participants
n=6 Participants
|
60 Participants
n=15 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=54 Participants
|
1 Participants
n=60 Participants
|
4 Participants
n=114 Participants
|
5 Participants
n=37 Participants
|
0 Participants
n=24 Participants
|
3 Participants
n=19 Participants
|
3 Participants
n=88 Participants
|
3 Participants
n=6 Participants
|
19 Participants
n=15 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=54 Participants
|
23 Participants
n=60 Participants
|
16 Participants
n=114 Participants
|
16 Participants
n=37 Participants
|
16 Participants
n=24 Participants
|
16 Participants
n=19 Participants
|
17 Participants
n=88 Participants
|
16 Participants
n=6 Participants
|
131 Participants
n=15 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=88 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=88 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
1 Participants
n=114 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=88 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=54 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=88 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=54 Participants
|
8 Participants
n=60 Participants
|
2 Participants
n=114 Participants
|
5 Participants
n=37 Participants
|
2 Participants
n=24 Participants
|
3 Participants
n=19 Participants
|
2 Participants
n=88 Participants
|
5 Participants
n=6 Participants
|
28 Participants
n=15 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=54 Participants
|
13 Participants
n=60 Participants
|
14 Participants
n=114 Participants
|
13 Participants
n=37 Participants
|
13 Participants
n=24 Participants
|
13 Participants
n=19 Participants
|
12 Participants
n=88 Participants
|
13 Participants
n=6 Participants
|
101 Participants
n=15 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=54 Participants
|
2 Participants
n=60 Participants
|
2 Participants
n=114 Participants
|
3 Participants
n=37 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=19 Participants
|
4 Participants
n=88 Participants
|
1 Participants
n=6 Participants
|
15 Participants
n=15 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=54 Participants
|
1 Participants
n=60 Participants
|
1 Participants
n=114 Participants
|
0 Participants
n=37 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=19 Participants
|
1 Participants
n=88 Participants
|
0 Participants
n=6 Participants
|
4 Participants
n=15 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=54 Participants
|
24 participants
n=60 Participants
|
20 participants
n=114 Participants
|
21 participants
n=37 Participants
|
16 participants
n=24 Participants
|
19 participants
n=19 Participants
|
20 participants
n=88 Participants
|
19 participants
n=6 Participants
|
150 participants
n=15 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 48The outcome values represent percent change in BMI from baseline to week 48.
Outcome measures
| Measure |
LSMT 12
n=11 Participants
Participants in this arm will start LSMT at baseline and have a weight loss response assessment at 12 weeks. If body mass index (BMI) is down 5% at 12 weeks, the participant will continue with LSMT for the remainder of the study; if BMI is not down 5% at 12 weeks, the participant will add phentermine to LSMT (phentermine+LSMT) and undergo a second weight loss response assessment at week 24.
|
LSMT 12+Phentermine
n=24 Participants
At 24 weeks, if BMI is down 5% with phentermine+LSMT, the participant will continue with phentermine+LSMT for the the remainder of study; if BMI is not down by 5% at 24 weeks, the participant will be randomized to topiramate+phentermine+LSMT or topiramate+placebo+LSMT for the remainder of the study.
Subjects will take 15 mg of phentermine every morning.
|
LSMT 12+Phentermine+Topiramate
n=19 Participants
At 24 weeks if BMI is not down by 5% the participant will be randomized to topiramate+phentermine+LSMT or topiramate+placebo+LSMT for the remainder of the study.
Phentermine Pill: Subjects will take 15 mg of phentermine every morning.
Topiramate Pill: Topiramate will begin at 50 mg every morning for 7 days, then increase to 100 mg every morning. At the end of week 48 the taper off will be 50 mg every morning for 7 days and then discontinue.
|
LSMT 12+Topiramate+Placebo
n=20 Participants
At 24 weeks, if BMI is down 5% with phentermine+LSMT, the participant will continue with phentermine+LSMT for the the remainder of study; if BMI is not down by 5% at 24 weeks, the participant will be randomized to topiramate+phentermine+LSMT or topiramate+placebo+LSMT for the remainder of the study.
Topiramate Pill: Topiramate will begin at 50 mg every morning for 7 days, then increase to 100 mg every morning. At the end of week 48 the taper off will be 50 mg every morning for 7 days and then discontinue.
Placebo Pill: Participant will take one placebo pill each morning.
|
LSMT 24
n=11 Participants
Participants in this arm will start LSMT at baseline and have a weight loss response assessment at 24 weeks: if body mass index (BMI) is down 5% at 24 weeks, the participant will continue with LSMT for the remainder of the study; if BMI is not down 5% at 24 weeks, the participant will add phentermine to LSMT (phentermine+LSMT) and undergo a second weight loss response assessment at 36 weeks.
|
LSMT 24+Phentermine
n=17 Participants
At 36 weeks, if BMI is down 5% with phentermine+LSMT, the participant will continue with phentermine+LSMT for the the remainder of study; if BMI is not down by 5% at 36 weeks, the participant will be randomized to topiramate+phentermine+LSMT or topiramate+placebo+LSMT for the remainder of the study.
Phentermine Pill: Phentermine will be started only if a participant does not lose 5% of BMI after 24 weeks of LSMT. Subjects will take 15 mg of phentermine every morning.
|
LSMT 24+Phentermine+Topiramate
n=20 Participants
At 36 weeks, if BMI is down 5% with phentermine+LSMT, the participant will continue with phentermine+LSMT for the the remainder of study; if BMI is not down by 5% at 36 weeks, the participant will be randomized to topiramate+phentermine+LSMT or topiramate+placebo+LSMT for the remainder of the study.
Phentermine Pill: Phentermine will be started only if a participant does not lose 5% of BMI after 24 weeks of LSMT. Subjects will take 15 mg of phentermine every morning.
Topiramate Pill: Topiramate will begin at 50 mg every morning for 7 days, then increase to 100 mg every morning. At the end of week 48 the taper off will be 50 mg every morning for 7 days and then discontinue.
|
LSMT+Topiramate+Placebo
n=19 Participants
At 36 weeks, if BMI is down 5% with phentermine+LSMT, the participant will continue with phentermine+LSMT for the the remainder of study; if BMI is not down by 5% at 36 weeks, the participant will be randomized to topiramate+phentermine+LSMT or topiramate+placebo+LSMT for the remainder of the study.
Topiramate Pill:Topiramate will begin at 50 mg every morning for 7 days, then increase to 100 mg every morning. At the end of week 48 the taper off will be 50 mg every morning for 7 days and then discontinue.
Placebo Pill: Participants will take one placebo pill in the morning.
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change in Body Mass Index (BMI)
|
-9.62 % change in body mass index (BMI)
Standard Deviation 7.00
|
-12.27 % change in body mass index (BMI)
Standard Deviation 8.2
|
-4.53 % change in body mass index (BMI)
Standard Deviation 8.42
|
-2.53 % change in body mass index (BMI)
Standard Deviation 5.97
|
-12.36 % change in body mass index (BMI)
Standard Deviation 7.71
|
-9.52 % change in body mass index (BMI)
Standard Deviation 5.17
|
-3.45 % change in body mass index (BMI)
Standard Deviation 5.11
|
-0.30 % change in body mass index (BMI)
Standard Deviation 5.05
|
Adverse Events
Arm 1: LSMT x 12
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Arm 1: LSMT 12 +Phentermine
Serious events: 2 serious events
Other events: 20 other events
Deaths: 0 deaths
Arm 1: LSMT +12+Phentermine+Topiramate
Serious events: 3 serious events
Other events: 20 other events
Deaths: 0 deaths
Arm 1: LSMT 12+Phentermine+Placebo
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
Arm 2: LSMT x 24
Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths
Arm 2: LSMT 24+Phentermine
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Arm 2: LSMT 24X Phentermine+Topiramate
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Arm 2: LSMT 24+Phentermine+Placebo
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1: LSMT x 12
n=11 participants at risk
Participants will start LSMT at baseline and have a weight loss assessment at 12 weeks: if BMI is down 5% at 12 weeks, the participant will continue with LSMT for the remainder of the study.
Lifestyle Modification Therapy: LSMT will consist of both in-person and by telephone sessions delivered throughout the entirety of the 48-week intervention phase. Each session will last 30-60 minutes.
|
Arm 1: LSMT 12 +Phentermine
n=24 participants at risk
Participants in this arm will start LSMT at baseline and have a weight loss assessment at 12 weeks: if BMI is not down 5% at 24 weeks, the participant will add phentermine to LSMT (phentermine+LSMT) and undergo a second weight loss assessment after 12 weeks of phentermine+LSMT.
Lifestyle Modification Therapy: LSMT will consist of both in-person and by telephone sessions delivered throughout the entirety of the 48-week intervention phase. Each session will last 30-60 minutes.
Phentermine Pill: Subjects will take 15 mg of phentermine every morning for 12 weeks. Subjects who achieve 5% or more BMI reduction after 12 weeks of phentermine will continue 15 mg every morning for the remainder of the study along with LSMT.
|
Arm 1: LSMT +12+Phentermine+Topiramate
n=20 participants at risk
Participants in this arm will start LSMT at baseline and have a weight loss assessment at 12 weeks: if BMI is not down 5% at 24 weeks, the participant will add phentermine to LSMT (phentermine+LSMT) and undergo a second weight loss assessment after 12 weeks of phentermine+LSMT. At 36 weeks, if BMI is not down by 5% the participant will be randomized to topiramate+phentermine+LSMT or topiramate+placebo+LSMT for the remainder of the study.
Lifestyle Modification Therapy: LSMT will consist of both in-person and by telephone sessions delivered throughout the entirety of the 48-week intervention phase. Each session will last 30-60 minutes.
Phentermine Pill: Subjects will take 15 mg of phentermine every morning for 12 weeks. Subjects who achieve 5% or more BMI reduction after 12 weeks of phentermine will continue 15 mg every morning for the remainder of the study along with LSMT.
Topiramate Pill: Participants who do no not achieve at least 5% BMI reduction after 12 weeks of phentermine+LSMT will be re-randomized 1:1 to either topiramate+phentermine+LSMT or topiramate+placebo+LSMT. Dosing will be 50 mg every morning for the first 7 days, then increase to 100 mg. Participants will taper off with 50 mg every morning for 7 days and then discontinue.
|
Arm 1: LSMT 12+Phentermine+Placebo
n=21 participants at risk
Participants in this arm will start LSMT at baseline and have a weight loss assessment at 12 weeks: if BMI is not down 5% at 24 weeks, the participant will add phentermine to LSMT (phentermine+LSMT) and undergo a second weight loss assessment after 12 weeks of phentermine+LSMT. At 36 weeks, if BMI is not down by 5% the participant will be randomized to topiramate+phentermine+LSMT or topiramate+placebo+LSMT for the remainder of the study.
Lifestyle Modification Therapy: LSMT will consist of both in-person and by telephone sessions delivered throughout the entirety of the 48-week intervention phase. Each session will last 30-60 minutes.
Topiramate Pill: Participants who do no not achieve at least 5% BMI reduction after 12 weeks of phentermine+LSMT will be re-randomized 1:1 to either topiramate+phentermine+LSMT or topiramate+placebo+LSMT. Dosing will be 50 mg every morning for the first 7 days, then increase to 100 mg. Participants will taper off with 50 mg every morning for 7 days and then discontinue.
|
Arm 2: LSMT x 24
n=16 participants at risk
Participants in this arm will start LSMT at baseline and have a weight loss assessment at 24 weeks: if BMI is down 5% at 24 weeks, the participant will continue with LSMT for the remainder of the study; if BMI is not down 5% at 24 weeks, the participant will add phentermine to LSMT (phentermine+LSMT) and undergo a second weight loss assessment after 12 weeks of phentermine+LSMT. At 36 weeks, if BMI is down 5% with phentermine+LSMT, the participant will continue with phentermine+LSMT for the the remainder of study; if BMI is not down by 5% the participant will be randomized to topiramate+phentermine+LSMT or topiramate+placebo+LSMT for the remainder of the study.
Lifestyle Modification Therapy: LSMT will consist of both in-person and by telephone sessions delivered throughout the entirety of the 48-week intervention phase. Each session will last 30-60 minutes.
Phentermine Pill: Subjects will take 15 mg of phentermine every morning for 12 weeks. Subjects who achieve 5% or more BMI reduction after 12 weeks of phentermine will continue 15 mg every morning for the remainder of the study along with LSMT.
Topiramate Pill: Participants who do no not achieve at least 5% BMI reduction after 12 weeks of phentermine+LSMT will be re-randomized 1:1 to either topiramate+phentermine+LSMT or topiramate+placebo+LSMT. Dosing will be 50 mg every morning for the first 7 days, then increase to 100 mg. Participants will taper off with 50 mg every morning for 7 days and then discontinue.
|
Arm 2: LSMT 24+Phentermine
n=19 participants at risk
Participants in this arm will start LSMT at baseline and have a weight loss assessment at 24 weeks; if BMI is not down 5% at 24 weeks, the participant will add phentermine to LSMT (phentermine+LSMT) and undergo a second weight loss assessment after 12 weeks of phentermine+LSMT.
Lifestyle Modification Therapy: LSMT will consist of both in-person and by telephone sessions delivered throughout the entirety of the 48-week intervention phase. Each session will last 30-60 minutes.
Phentermine Pill: Subjects will take 15 mg of phentermine every morning for 12 weeks. Subjects who achieve 5% or more BMI reduction after 12 weeks of phentermine will continue 15 mg every morning for the remainder of the study along with LSMT.
|
Arm 2: LSMT 24X Phentermine+Topiramate
n=20 participants at risk
Participants in this arm be assessed at 36 weeks, if BMI is down 5% with phentermine+LSMT, the participant will continue with phentermine+LSMT for the the remainder of study
Lifestyle Modification Therapy: LSMT will consist of both in-person and by telephone sessions delivered throughout the entirety of the 48-week intervention phase. Each session will last 30-60 minutes.
Phentermine Pill: Subjects will take 15 mg of phentermine every morning for 12 weeks. Subjects who achieve 5% or more BMI reduction after 12 weeks of phentermine will continue 15 mg every morning for the remainder of the study along with LSMT.
Topiramate Pill: Participants who do no not achieve at least 5% BMI reduction after 12 weeks of phentermine+LSMT will be re-randomized 1:1 to either topiramate+phentermine+LSMT or topiramate+placebo+LSMT. Dosing will be 50 mg every morning for the first 7 days, then increase to 100 mg. Participants will taper off with 50 mg every morning for 7 days and then discontinue.
|
Arm 2: LSMT 24+Phentermine+Placebo
n=19 participants at risk
Participants in this arm be assessed at 36 weeks, if BMI is down 5% with phentermine+LSMT, the participant will continue with phentermine+LSMT for the the remainder of study
Lifestyle Modification Therapy: LSMT will consist of both in-person and by telephone sessions delivered throughout the entirety of the 48-week intervention phase. Each session will last 30-60 minutes.
Phentermine Pill: Subjects will take 15 mg of phentermine every morning for 12 weeks. Subjects who achieve 5% or more BMI reduction after 12 weeks of phentermine will continue 15 mg every morning for the remainder of the study along with LSMT.
Topiramate Pill: Participants who do no not achieve at least 5% BMI reduction after 12 weeks of phentermine+LSMT will be re-randomized 1:1 to either topiramate+phentermine+LSMT or topiramate+placebo+LSMT. Dosing will be 50 mg every morning for the first 7 days, then increase to 100 mg. Participants will taper off with 50 mg every morning for 7 days and then discontinue.
|
|---|---|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
0.00%
0/24 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
0.00%
0/20 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
0.00%
0/21 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
0.00%
0/16 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
0.00%
0/19 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
0.00%
0/20 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
0.00%
0/19 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
|
Hepatobiliary disorders
Cholecystectomy
|
0.00%
0/11 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
0.00%
0/24 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
0.00%
0/20 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
0.00%
0/21 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
0.00%
0/19 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
0.00%
0/20 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
0.00%
0/19 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
|
Respiratory, thoracic and mediastinal disorders
Status Asthmaticus
|
0.00%
0/11 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
0.00%
0/24 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
0.00%
0/21 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
0.00%
0/16 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
0.00%
0/19 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
0.00%
0/20 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
0.00%
0/19 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
|
Gastrointestinal disorders
Foodborne Illness
|
0.00%
0/11 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
0.00%
0/24 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
0.00%
0/21 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
0.00%
0/16 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
0.00%
0/19 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
0.00%
0/20 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
0.00%
0/19 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
|
Psychiatric disorders
Self-Injurious Behavior
|
0.00%
0/11 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
4.2%
1/24 • Number of events 1 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
0.00%
0/19 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
0.00%
0/20 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
0.00%
0/19 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
|
Psychiatric disorders
Auditory Hallucination
|
0.00%
0/11 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
4.2%
1/24 • Number of events 1 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
0.00%
0/20 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
0.00%
0/21 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
0.00%
0/16 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
0.00%
0/19 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
0.00%
0/20 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
0.00%
0/19 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
Other adverse events
| Measure |
Arm 1: LSMT x 12
n=11 participants at risk
Participants will start LSMT at baseline and have a weight loss assessment at 12 weeks: if BMI is down 5% at 12 weeks, the participant will continue with LSMT for the remainder of the study.
Lifestyle Modification Therapy: LSMT will consist of both in-person and by telephone sessions delivered throughout the entirety of the 48-week intervention phase. Each session will last 30-60 minutes.
|
Arm 1: LSMT 12 +Phentermine
n=24 participants at risk
Participants in this arm will start LSMT at baseline and have a weight loss assessment at 12 weeks: if BMI is not down 5% at 24 weeks, the participant will add phentermine to LSMT (phentermine+LSMT) and undergo a second weight loss assessment after 12 weeks of phentermine+LSMT.
Lifestyle Modification Therapy: LSMT will consist of both in-person and by telephone sessions delivered throughout the entirety of the 48-week intervention phase. Each session will last 30-60 minutes.
Phentermine Pill: Subjects will take 15 mg of phentermine every morning for 12 weeks. Subjects who achieve 5% or more BMI reduction after 12 weeks of phentermine will continue 15 mg every morning for the remainder of the study along with LSMT.
|
Arm 1: LSMT +12+Phentermine+Topiramate
n=20 participants at risk
Participants in this arm will start LSMT at baseline and have a weight loss assessment at 12 weeks: if BMI is not down 5% at 24 weeks, the participant will add phentermine to LSMT (phentermine+LSMT) and undergo a second weight loss assessment after 12 weeks of phentermine+LSMT. At 36 weeks, if BMI is not down by 5% the participant will be randomized to topiramate+phentermine+LSMT or topiramate+placebo+LSMT for the remainder of the study.
Lifestyle Modification Therapy: LSMT will consist of both in-person and by telephone sessions delivered throughout the entirety of the 48-week intervention phase. Each session will last 30-60 minutes.
Phentermine Pill: Subjects will take 15 mg of phentermine every morning for 12 weeks. Subjects who achieve 5% or more BMI reduction after 12 weeks of phentermine will continue 15 mg every morning for the remainder of the study along with LSMT.
Topiramate Pill: Participants who do no not achieve at least 5% BMI reduction after 12 weeks of phentermine+LSMT will be re-randomized 1:1 to either topiramate+phentermine+LSMT or topiramate+placebo+LSMT. Dosing will be 50 mg every morning for the first 7 days, then increase to 100 mg. Participants will taper off with 50 mg every morning for 7 days and then discontinue.
|
Arm 1: LSMT 12+Phentermine+Placebo
n=21 participants at risk
Participants in this arm will start LSMT at baseline and have a weight loss assessment at 12 weeks: if BMI is not down 5% at 24 weeks, the participant will add phentermine to LSMT (phentermine+LSMT) and undergo a second weight loss assessment after 12 weeks of phentermine+LSMT. At 36 weeks, if BMI is not down by 5% the participant will be randomized to topiramate+phentermine+LSMT or topiramate+placebo+LSMT for the remainder of the study.
Lifestyle Modification Therapy: LSMT will consist of both in-person and by telephone sessions delivered throughout the entirety of the 48-week intervention phase. Each session will last 30-60 minutes.
Topiramate Pill: Participants who do no not achieve at least 5% BMI reduction after 12 weeks of phentermine+LSMT will be re-randomized 1:1 to either topiramate+phentermine+LSMT or topiramate+placebo+LSMT. Dosing will be 50 mg every morning for the first 7 days, then increase to 100 mg. Participants will taper off with 50 mg every morning for 7 days and then discontinue.
|
Arm 2: LSMT x 24
n=16 participants at risk
Participants in this arm will start LSMT at baseline and have a weight loss assessment at 24 weeks: if BMI is down 5% at 24 weeks, the participant will continue with LSMT for the remainder of the study; if BMI is not down 5% at 24 weeks, the participant will add phentermine to LSMT (phentermine+LSMT) and undergo a second weight loss assessment after 12 weeks of phentermine+LSMT. At 36 weeks, if BMI is down 5% with phentermine+LSMT, the participant will continue with phentermine+LSMT for the the remainder of study; if BMI is not down by 5% the participant will be randomized to topiramate+phentermine+LSMT or topiramate+placebo+LSMT for the remainder of the study.
Lifestyle Modification Therapy: LSMT will consist of both in-person and by telephone sessions delivered throughout the entirety of the 48-week intervention phase. Each session will last 30-60 minutes.
Phentermine Pill: Subjects will take 15 mg of phentermine every morning for 12 weeks. Subjects who achieve 5% or more BMI reduction after 12 weeks of phentermine will continue 15 mg every morning for the remainder of the study along with LSMT.
Topiramate Pill: Participants who do no not achieve at least 5% BMI reduction after 12 weeks of phentermine+LSMT will be re-randomized 1:1 to either topiramate+phentermine+LSMT or topiramate+placebo+LSMT. Dosing will be 50 mg every morning for the first 7 days, then increase to 100 mg. Participants will taper off with 50 mg every morning for 7 days and then discontinue.
|
Arm 2: LSMT 24+Phentermine
n=19 participants at risk
Participants in this arm will start LSMT at baseline and have a weight loss assessment at 24 weeks; if BMI is not down 5% at 24 weeks, the participant will add phentermine to LSMT (phentermine+LSMT) and undergo a second weight loss assessment after 12 weeks of phentermine+LSMT.
Lifestyle Modification Therapy: LSMT will consist of both in-person and by telephone sessions delivered throughout the entirety of the 48-week intervention phase. Each session will last 30-60 minutes.
Phentermine Pill: Subjects will take 15 mg of phentermine every morning for 12 weeks. Subjects who achieve 5% or more BMI reduction after 12 weeks of phentermine will continue 15 mg every morning for the remainder of the study along with LSMT.
|
Arm 2: LSMT 24X Phentermine+Topiramate
n=20 participants at risk
Participants in this arm be assessed at 36 weeks, if BMI is down 5% with phentermine+LSMT, the participant will continue with phentermine+LSMT for the the remainder of study
Lifestyle Modification Therapy: LSMT will consist of both in-person and by telephone sessions delivered throughout the entirety of the 48-week intervention phase. Each session will last 30-60 minutes.
Phentermine Pill: Subjects will take 15 mg of phentermine every morning for 12 weeks. Subjects who achieve 5% or more BMI reduction after 12 weeks of phentermine will continue 15 mg every morning for the remainder of the study along with LSMT.
Topiramate Pill: Participants who do no not achieve at least 5% BMI reduction after 12 weeks of phentermine+LSMT will be re-randomized 1:1 to either topiramate+phentermine+LSMT or topiramate+placebo+LSMT. Dosing will be 50 mg every morning for the first 7 days, then increase to 100 mg. Participants will taper off with 50 mg every morning for 7 days and then discontinue.
|
Arm 2: LSMT 24+Phentermine+Placebo
n=19 participants at risk
Participants in this arm be assessed at 36 weeks, if BMI is down 5% with phentermine+LSMT, the participant will continue with phentermine+LSMT for the the remainder of study
Lifestyle Modification Therapy: LSMT will consist of both in-person and by telephone sessions delivered throughout the entirety of the 48-week intervention phase. Each session will last 30-60 minutes.
Phentermine Pill: Subjects will take 15 mg of phentermine every morning for 12 weeks. Subjects who achieve 5% or more BMI reduction after 12 weeks of phentermine will continue 15 mg every morning for the remainder of the study along with LSMT.
Topiramate Pill: Participants who do no not achieve at least 5% BMI reduction after 12 weeks of phentermine+LSMT will be re-randomized 1:1 to either topiramate+phentermine+LSMT or topiramate+placebo+LSMT. Dosing will be 50 mg every morning for the first 7 days, then increase to 100 mg. Participants will taper off with 50 mg every morning for 7 days and then discontinue.
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Infections and Infestations: Other
|
18.2%
2/11 • Number of events 3 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
12.5%
3/24 • Number of events 4 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
15.0%
3/20 • Number of events 5 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
28.6%
6/21 • Number of events 9 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
37.5%
6/16 • Number of events 8 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
26.3%
5/19 • Number of events 9 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
25.0%
5/20 • Number of events 8 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
36.8%
7/19 • Number of events 11 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
|
Psychiatric disorders
Psychiatric Disorders: Other
|
0.00%
0/11 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
20.8%
5/24 • Number of events 7 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
10.0%
2/20 • Number of events 2 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
33.3%
7/21 • Number of events 12 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
18.8%
3/16 • Number of events 4 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
10.5%
2/19 • Number of events 5 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
25.0%
5/20 • Number of events 5 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
15.8%
3/19 • Number of events 4 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/11 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
12.5%
3/24 • Number of events 3 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
15.0%
3/20 • Number of events 3 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
14.3%
3/21 • Number of events 3 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
0.00%
0/16 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
20.0%
4/20 • Number of events 5 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
10.5%
2/19 • Number of events 2 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
|
Nervous system disorders
Paresthesia
|
0.00%
0/11 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
0.00%
0/24 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
15.0%
3/20 • Number of events 3 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
33.3%
7/21 • Number of events 8 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
0.00%
0/19 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
20.0%
4/20 • Number of events 4 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
|
Nervous system disorders
Headaches
|
18.2%
2/11 • Number of events 4 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
4.2%
1/24 • Number of events 1 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
10.0%
2/20 • Number of events 2 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
14.3%
3/21 • Number of events 3 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
5.3%
1/19 • Number of events 2 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
15.8%
3/19 • Number of events 3 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
|
Psychiatric disorders
Depressed Mood
|
9.1%
1/11 • Number of events 2 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
4.2%
1/24 • Number of events 1 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
10.0%
2/20 • Number of events 2 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
10.5%
2/19 • Number of events 2 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
20.0%
4/20 • Number of events 4 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
10.5%
2/19 • Number of events 2 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
|
Injury, poisoning and procedural complications
Injury, poisoning, and procedural complications: other
|
9.1%
1/11 • Number of events 1 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
4.2%
1/24 • Number of events 1 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
15.0%
3/20 • Number of events 3 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
12.5%
2/16 • Number of events 6 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
10.5%
2/19 • Number of events 4 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
0.00%
0/20 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
15.8%
3/19 • Number of events 4 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/11 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
8.3%
2/24 • Number of events 2 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
9.5%
2/21 • Number of events 2 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
12.5%
2/16 • Number of events 2 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
10.5%
2/19 • Number of events 2 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
15.0%
3/20 • Number of events 3 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
|
General disorders
Sleepiness/fatigue
|
0.00%
0/11 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
8.3%
2/24 • Number of events 2 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
20.0%
4/20 • Number of events 4 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
4.8%
1/21 • Number of events 1 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
12.5%
2/16 • Number of events 2 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
0.00%
0/19 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
10.0%
2/20 • Number of events 2 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
|
Gastrointestinal disorders
Gastrointestinal Disorders: Other
|
18.2%
2/11 • Number of events 2 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
0.00%
0/24 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
10.0%
2/20 • Number of events 2 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
19.0%
4/21 • Number of events 6 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
0.00%
0/16 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
0.00%
0/19 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
10.0%
2/20 • Number of events 2 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/11 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
0.00%
0/24 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
10.0%
2/20 • Number of events 2 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
9.5%
2/21 • Number of events 2 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
12.5%
2/16 • Number of events 2 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
10.0%
2/20 • Number of events 2 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
|
Nervous system disorders
Difficulty focusing or concentrating
|
9.1%
1/11 • Number of events 2 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
0.00%
0/24 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
9.5%
2/21 • Number of events 2 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
12.5%
2/16 • Number of events 2 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
10.5%
2/19 • Number of events 2 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
|
Psychiatric disorders
Agitation/Irritability
|
18.2%
2/11 • Number of events 2 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
8.3%
2/24 • Number of events 2 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
0.00%
0/21 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
6.2%
1/16 • Number of events 2 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
15.0%
3/20 • Number of events 3 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
0.00%
0/19 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/11 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
0.00%
0/24 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
10.0%
2/20 • Number of events 2 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
9.5%
2/21 • Number of events 2 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
6.2%
1/16 • Number of events 1 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
10.5%
2/19 • Number of events 2 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
5.0%
1/20 • Number of events 1 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
5.3%
1/19 • Number of events 1 • Adverse event data were collected Randomization through Week 48.
Our adverse event (AE) and serious adverse event (SAE) definitions match that of clinicaltrials.gov.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place