Trial Outcomes & Findings for Individualized Obesity Pharmacotherapy (NCT NCT03374956)
NCT ID: NCT03374956
Last Updated: 2023-07-18
Results Overview
Percent change in body weight
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
193 participants
Primary outcome timeframe
baseline to 12 weeks
Results posted on
2023-07-18
Participant Flow
Participant milestones
| Measure |
Intervention Group
Phenotype-guided pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine plus Exercise
Phentermine-Topiramate: Extended Release at dose of 7.5/46 mg oral daily
Liraglutide: dose of 3 mg subcutaneous daily
Naltrexone/bupropion: Oral naltrexone extended-release/bupropion extended-release at dose of 32/360 mg oral daily (divided in 2 tables in morning and 2 tablets in evening)
|
Control Group
Randomly assigned pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine
Phentermine-Topiramate: Extended Release at dose of 7.5/46 mg oral daily
Liraglutide: dose of 3 mg subcutaneous daily
Naltrexone/bupropion: Oral naltrexone extended-release/bupropion extended-release at dose of 32/360 mg oral daily (divided in 2 tables in morning and 2 tablets in evening)
Phentermine: 15-37.5 mg oral daily
|
|---|---|---|
|
Overall Study
STARTED
|
93
|
100
|
|
Overall Study
COMPLETED
|
93
|
100
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Individualized Obesity Pharmacotherapy
Baseline characteristics by cohort
| Measure |
Intervention Group
n=93 Participants
Phenotype-guided pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine plus Exercise
Phentermine-Topiramate: Extended Release at dose of 7.5/46 mg oral daily
Liraglutide: dose of 3 mg subcutaneous daily
Naltrexone/bupropion: Oral naltrexone extended-release/bupropion extended-release at dose of 32/360 mg oral daily (divided in 2 tables in morning and 2 tablets in evening)
|
Control Group
n=100 Participants
Randomly assigned pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine
Phentermine-Topiramate: Extended Release at dose of 7.5/46 mg oral daily
Liraglutide: dose of 3 mg subcutaneous daily
Naltrexone/bupropion: Oral naltrexone extended-release/bupropion extended-release at dose of 32/360 mg oral daily (divided in 2 tables in morning and 2 tablets in evening)
Phentermine: 15-37.5 mg oral daily
|
Total
n=193 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
|
|
Age, Categorical
Between 18 and 65 years
|
93 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
193 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
38.5 years
STANDARD_DEVIATION 16 • n=5 Participants
|
39 years
STANDARD_DEVIATION 14 • n=7 Participants
|
39 years
STANDARD_DEVIATION 15 • n=5 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
143 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
50 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
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 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
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
88 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
175 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
|
3 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
93 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
193 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baseline to 12 weeksPercent change in body weight
Outcome measures
| Measure |
Intervention Group
n=93 Participants
Phenotype-guided pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine plus Exercise
Phentermine-Topiramate: Extended Release at dose of 7.5/46 mg oral daily
Liraglutide: dose of 3 mg subcutaneous daily
Naltrexone/bupropion: Oral naltrexone extended-release/bupropion extended-release at dose of 32/360 mg oral daily (divided in 2 tables in morning and 2 tablets in evening)
|
Control Group
n=100 Participants
Randomly assigned pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine
Phentermine-Topiramate: Extended Release at dose of 7.5/46 mg oral daily
Liraglutide: dose of 3 mg subcutaneous daily
Naltrexone/bupropion: Oral naltrexone extended-release/bupropion extended-release at dose of 32/360 mg oral daily (divided in 2 tables in morning and 2 tablets in evening)
Phentermine: 15-37.5 mg oral daily
|
|---|---|---|
|
Change in Total Body Weight
|
-7.7 percent change
Interval -11.0 to -4.7
|
-6.5 percent change
Interval -11.0 to -2.3
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPercentage of participants who loss 5% or more of total body weight
Outcome measures
| Measure |
Intervention Group
n=93 Participants
Phenotype-guided pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine plus Exercise
Phentermine-Topiramate: Extended Release at dose of 7.5/46 mg oral daily
Liraglutide: dose of 3 mg subcutaneous daily
Naltrexone/bupropion: Oral naltrexone extended-release/bupropion extended-release at dose of 32/360 mg oral daily (divided in 2 tables in morning and 2 tablets in evening)
|
Control Group
n=100 Participants
Randomly assigned pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine
Phentermine-Topiramate: Extended Release at dose of 7.5/46 mg oral daily
Liraglutide: dose of 3 mg subcutaneous daily
Naltrexone/bupropion: Oral naltrexone extended-release/bupropion extended-release at dose of 32/360 mg oral daily (divided in 2 tables in morning and 2 tablets in evening)
Phentermine: 15-37.5 mg oral daily
|
|---|---|---|
|
Percentage of Responders
|
81 percentage of participants
|
80 percentage of participants
|
SECONDARY outcome
Timeframe: baseline to 12 weeksPercentage of participants with at least 10% total body weight loss
Outcome measures
| Measure |
Intervention Group
n=93 Participants
Phenotype-guided pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine plus Exercise
Phentermine-Topiramate: Extended Release at dose of 7.5/46 mg oral daily
Liraglutide: dose of 3 mg subcutaneous daily
Naltrexone/bupropion: Oral naltrexone extended-release/bupropion extended-release at dose of 32/360 mg oral daily (divided in 2 tables in morning and 2 tablets in evening)
|
Control Group
n=100 Participants
Randomly assigned pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine
Phentermine-Topiramate: Extended Release at dose of 7.5/46 mg oral daily
Liraglutide: dose of 3 mg subcutaneous daily
Naltrexone/bupropion: Oral naltrexone extended-release/bupropion extended-release at dose of 32/360 mg oral daily (divided in 2 tables in morning and 2 tablets in evening)
Phentermine: 15-37.5 mg oral daily
|
|---|---|---|
|
Percentage of Responders
|
44 percentage of participants
|
40 percentage of participants
|
Adverse Events
Intervention Group
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intervention Group
n=93 participants at risk
Phenotype-guided pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine plus Exercise
Phentermine-Topiramate: Extended Release at dose of 7.5/46 mg oral daily
Liraglutide: dose of 3 mg subcutaneous daily
Naltrexone/bupropion: Oral naltrexone extended-release/bupropion extended-release at dose of 32/360 mg oral daily (divided in 2 tables in morning and 2 tablets in evening)
|
Control Group
n=100 participants at risk
Randomly assigned pharmacotherapy, which includes Phentermine-Topiramate, Liraglutide, Naltrexone/bupropion or Phentermine
Phentermine-Topiramate: Extended Release at dose of 7.5/46 mg oral daily
Liraglutide: dose of 3 mg subcutaneous daily
Naltrexone/bupropion: Oral naltrexone extended-release/bupropion extended-release at dose of 32/360 mg oral daily (divided in 2 tables in morning and 2 tablets in evening)
Phentermine: 15-37.5 mg oral daily
|
|---|---|---|
|
Gastrointestinal disorders
During study
|
24.7%
23/93 • Number of events 23 • Baseline to 12 months
|
25.0%
25/100 • Number of events 25 • Baseline to 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place