Trial Outcomes & Findings for A Pharmacokinetic Study Comparing VI-0521 With Placebo in Obese Adolescents (NCT NCT02714062)
NCT ID: NCT02714062
Last Updated: 2022-08-23
Results Overview
A Bayesian analysis was performed to derive posterior Bayes individual pharmacokinetic (PK) parameters.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
42 participants
Primary outcome timeframe
On Days 14, 28, 42, and 56
Results posted on
2022-08-23
Participant Flow
Participant milestones
| Measure |
Placebo
Days 1-56: Placebo
|
VI-0521 Mid Dose
* Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 15-56: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
|
VI-0521 Top Dose
* Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 15-28: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
* Days 29-42: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)
* Days 43-56: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)
|
|---|---|---|---|
|
Overall Study
STARTED
|
14
|
15
|
13
|
|
Overall Study
COMPLETED
|
13
|
14
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
3
|
Reasons for withdrawal
| Measure |
Placebo
Days 1-56: Placebo
|
VI-0521 Mid Dose
* Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 15-56: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
|
VI-0521 Top Dose
* Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 15-28: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
* Days 29-42: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)
* Days 43-56: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
Baseline Characteristics
A Pharmacokinetic Study Comparing VI-0521 With Placebo in Obese Adolescents
Baseline characteristics by cohort
| Measure |
Placebo
n=14 Participants
Days 1-56: Placebo
|
VI-0521 Mid Dose
n=15 Participants
* Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 15-56: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
|
VI-0521 Top Dose
n=13 Participants
* Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 15-28: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
* Days 29-42: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)
* Days 43-56: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
14.1 years
STANDARD_DEVIATION 1.56 • n=5 Participants
|
14.4 years
STANDARD_DEVIATION 1.30 • n=7 Participants
|
14.3 years
STANDARD_DEVIATION 1.55 • n=5 Participants
|
14.3 years
STANDARD_DEVIATION 1.44 • n=4 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 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
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 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
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: On Days 14, 28, 42, and 56Population: PK samples were not collected for some patients due to withdrawal, or missed visits, etc. As a result, number analyzed for some visits is less than overall number analyzed.
A Bayesian analysis was performed to derive posterior Bayes individual pharmacokinetic (PK) parameters.
Outcome measures
| Measure |
VI-0521 Mid Dose
n=15 Participants
* Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 15-56: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
|
VI-0521 Top Dose
n=13 Participants
* Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 15-28: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
* Days 29-42: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)
* Days 43-56: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)
|
VI-0521 Top Dose
* Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 15-28: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
* Days 29-42: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)
* Days 43-56: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)
|
|---|---|---|---|
|
Apparent Clearance (CL/F) of Phentermine and Topiramate
Day 42 (Phentermine)
|
6.82 L/h
Standard Deviation 1.69
|
6.49 L/h
Standard Deviation 2.15
|
—
|
|
Apparent Clearance (CL/F) of Phentermine and Topiramate
Day 56 (Phentermine)
|
6.82 L/h
Standard Deviation 1.69
|
6.67 L/h
Standard Deviation 2.18
|
—
|
|
Apparent Clearance (CL/F) of Phentermine and Topiramate
Day 14 (Topiramate)
|
1.32 L/h
Standard Deviation 0.333
|
1.25 L/h
Standard Deviation 0.307
|
—
|
|
Apparent Clearance (CL/F) of Phentermine and Topiramate
Day 28 (Topiramate)
|
1.32 L/h
Standard Deviation 0.333
|
1.27 L/h
Standard Deviation 0.300
|
—
|
|
Apparent Clearance (CL/F) of Phentermine and Topiramate
Day 42 (Topiramate)
|
1.25 L/h
Standard Deviation 0.291
|
1.20 L/h
Standard Deviation 0.257
|
—
|
|
Apparent Clearance (CL/F) of Phentermine and Topiramate
Day 56 (Topiramate)
|
1.25 L/h
Standard Deviation 0.291
|
1.18 L/h
Standard Deviation 0.265
|
—
|
|
Apparent Clearance (CL/F) of Phentermine and Topiramate
Day 14 (Phentermine)
|
7.33 L/h
Standard Deviation 1.63
|
7.04 L/h
Standard Deviation 2.65
|
—
|
|
Apparent Clearance (CL/F) of Phentermine and Topiramate
Day 28 (Phentermine)
|
7.33 L/h
Standard Deviation 1.63
|
7.18 L/h
Standard Deviation 2.57
|
—
|
PRIMARY outcome
Timeframe: On Days 14, 28, 42, and 56Population: PK samples were not collected for some patients due to withdrawal, or missed visits, etc. As a result, number analyzed for some visits is less than overall number analyzed.
A Bayesian analysis was performed to derive posterior Bayes individual PK parameters.
Outcome measures
| Measure |
VI-0521 Mid Dose
n=15 Participants
* Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 15-56: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
|
VI-0521 Top Dose
n=13 Participants
* Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 15-28: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
* Days 29-42: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)
* Days 43-56: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)
|
VI-0521 Top Dose
* Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 15-28: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
* Days 29-42: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)
* Days 43-56: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)
|
|---|---|---|---|
|
Apparent Volume of Distribution (Vc/F) of Phentermine and Topiramate
Day 14 (Phentermine)
|
289 L
Standard Deviation 80.4
|
289 L
Standard Deviation 70.4
|
—
|
|
Apparent Volume of Distribution (Vc/F) of Phentermine and Topiramate
Day 28 (Phentermine)
|
287 L
Standard Deviation 79.8
|
291 L
Standard Deviation 69.6
|
—
|
|
Apparent Volume of Distribution (Vc/F) of Phentermine and Topiramate
Day 42 (Phentermine)
|
284 L
Standard Deviation 79.3
|
298 L
Standard Deviation 62.1
|
—
|
|
Apparent Volume of Distribution (Vc/F) of Phentermine and Topiramate
Day 56 (Phentermine)
|
281 L
Standard Deviation 78.8
|
299 L
Standard Deviation 64.6
|
—
|
|
Apparent Volume of Distribution (Vc/F) of Phentermine and Topiramate
Day 14 (Topiramate)
|
46.8 L
Standard Deviation 17.7
|
46.1 L
Standard Deviation 13.5
|
—
|
|
Apparent Volume of Distribution (Vc/F) of Phentermine and Topiramate
Day 28 (Topiramate)
|
46.2 L
Standard Deviation 17.5
|
46.6 L
Standard Deviation 13.5
|
—
|
|
Apparent Volume of Distribution (Vc/F) of Phentermine and Topiramate
Day 42 (Topiramate)
|
45.7 L
Standard Deviation 17.3
|
48.2 L
Standard Deviation 11.5
|
—
|
|
Apparent Volume of Distribution (Vc/F) of Phentermine and Topiramate
Day 56 (Topiramate)
|
45.2 L
Standard Deviation 17.2
|
47.5 L
Standard Deviation 12.3
|
—
|
PRIMARY outcome
Timeframe: On Days 14, 28, 42, and 56Population: PK samples were not collected for some patients due to withdrawal, or missed visits, etc. As a result, number analyzed for some visits is less than overall number analyzed.
A Bayesian analysis was performed to derive posterior Bayes individual PK parameters. AUC from time 0 to 24 hours under steady-state.
Outcome measures
| Measure |
VI-0521 Mid Dose
n=15 Participants
* Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 15-56: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
|
VI-0521 Top Dose
n=13 Participants
* Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 15-28: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
* Days 29-42: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)
* Days 43-56: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)
|
VI-0521 Top Dose
* Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 15-28: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
* Days 29-42: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)
* Days 43-56: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)
|
|---|---|---|---|
|
Area Under the Curve (AUC) of Phentermine
Day 14 (Phentermine)
|
533 ng•h/mL
Standard Deviation 109
|
600 ng•h/mL
Standard Deviation 205
|
—
|
|
Area Under the Curve (AUC) of Phentermine
Day 28 (Phentermine)
|
1066 ng•h/mL
Standard Deviation 218
|
1171 ng•h/mL
Standard Deviation 403
|
—
|
|
Area Under the Curve (AUC) of Phentermine
Day 42 (Phentermine)
|
1154 ng•h/mL
Standard Deviation 240
|
1902 ng•h/mL
Standard Deviation 576
|
—
|
|
Area Under the Curve (AUC) of Phentermine
Day 56 (Phentermine)
|
1154 ng•h/mL
Standard Deviation 240
|
2469 ng•h/mL
Standard Deviation 775
|
—
|
PRIMARY outcome
Timeframe: On Days 14, 28, 42, and 56Population: PK samples were not collected for some patients due to withdrawal, or missed visits, etc. As a result, number analyzed for some visits is less than overall number analyzed.
A Bayesian analysis was performed to derive posterior Bayes individual PK parameters.
Outcome measures
| Measure |
VI-0521 Mid Dose
n=15 Participants
* Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 15-56: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
|
VI-0521 Top Dose
n=13 Participants
* Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 15-28: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
* Days 29-42: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)
* Days 43-56: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)
|
VI-0521 Top Dose
* Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 15-28: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
* Days 29-42: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)
* Days 43-56: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)
|
|---|---|---|---|
|
Maximum Concentration (Cmax) of Phentermine
Day 14 (Phentermine)
|
27.6 ng/mL
Standard Deviation 5.34
|
30.3 ng/mL
Standard Deviation 9.61
|
—
|
|
Maximum Concentration (Cmax) of Phentermine
Day 28 (Phentermine)
|
55.3 ng/mL
Standard Deviation 10.7
|
59.3 ng/mL
Standard Deviation 19.0
|
—
|
|
Maximum Concentration (Cmax) of Phentermine
Day 42 (Phentermine)
|
59.0 ng/mL
Standard Deviation 11.6
|
94.2 ng/mL
Standard Deviation 25.9
|
—
|
|
Maximum Concentration (Cmax) of Phentermine
Day 56 (Phentermine)
|
59.1 ng/mL
Standard Deviation 11.6
|
123 ng/mL
Standard Deviation 34.8
|
—
|
PRIMARY outcome
Timeframe: On Days 14, 28, 42, and 56Population: PK samples were not collected for some patients due to withdrawal, or missed visits, etc. As a result, number analyzed for some visits is less than overall number analyzed.
A Bayesian analysis was performed to derive posterior Bayes individual PK parameters. AUC from time 0 to 24 hours under steady-state.
Outcome measures
| Measure |
VI-0521 Mid Dose
n=15 Participants
* Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 15-56: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
|
VI-0521 Top Dose
n=13 Participants
* Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 15-28: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
* Days 29-42: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)
* Days 43-56: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)
|
VI-0521 Top Dose
* Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 15-28: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
* Days 29-42: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)
* Days 43-56: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)
|
|---|---|---|---|
|
Area Under the Curve (AUC) of Topiramate
Day 14 (Topiramate)
|
18.5 μg•h/mL
Standard Deviation 4.49
|
19.4 μg•h/mL
Standard Deviation 4.75
|
—
|
|
Area Under the Curve (AUC) of Topiramate
Day 28 (Topiramate)
|
37.0 μg•h/mL
Standard Deviation 8.98
|
38.2 μg•h/mL
Standard Deviation 9.33
|
—
|
|
Area Under the Curve (AUC) of Topiramate
Day 42 (Topiramate)
|
38.8 μg•h/mL
Standard Deviation 8.90
|
60.1 μg•h/mL
Standard Deviation 13.1
|
—
|
|
Area Under the Curve (AUC) of Topiramate
Day 56 (Topiramate)
|
38.8 μg•h/mL
Standard Deviation 8.90
|
81.4 μg•h/mL
Standard Deviation 17.9
|
—
|
PRIMARY outcome
Timeframe: On Days 14, 28, 42, and 56Population: PK samples were not collected for some patients due to withdrawal, or missed visits, etc. As a result, number analyzed for some visits is less than overall number analyzed.
A Bayesian analysis was performed to derive posterior Bayes individual PK parameters.
Outcome measures
| Measure |
VI-0521 Mid Dose
n=15 Participants
* Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 15-56: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
|
VI-0521 Top Dose
n=13 Participants
* Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 15-28: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
* Days 29-42: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)
* Days 43-56: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)
|
VI-0521 Top Dose
* Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 15-28: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
* Days 29-42: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)
* Days 43-56: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)
|
|---|---|---|---|
|
Maximum Concentration (Cmax) of Topiramate
Day 14 (Topiramate)
|
0.917 μg/mL
Standard Deviation 0.226
|
0.952 μg/mL
Standard Deviation 0.236
|
—
|
|
Maximum Concentration (Cmax) of Topiramate
Day 28 (Topiramate)
|
1.84 μg/mL
Standard Deviation 0.454
|
1.88 μg/mL
Standard Deviation 0.465
|
—
|
|
Maximum Concentration (Cmax) of Topiramate
Day 42 (Topiramate)
|
1.92 μg/mL
Standard Deviation 0.454
|
2.90 μg/mL
Standard Deviation 0.594
|
—
|
|
Maximum Concentration (Cmax) of Topiramate
Day 56 (Topiramate)
|
1.92 μg/mL
Standard Deviation 0.456
|
3.93 μg/mL
Standard Deviation 0.817
|
—
|
SECONDARY outcome
Timeframe: 56 daysPopulation: The number of subjects with values at both time points (Baseline and Day 56)
Mean percent weight change from baseline to Day 56
Outcome measures
| Measure |
VI-0521 Mid Dose
n=13 Participants
* Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 15-56: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
|
VI-0521 Top Dose
n=15 Participants
* Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 15-28: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
* Days 29-42: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)
* Days 43-56: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)
|
VI-0521 Top Dose
n=12 Participants
* Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 15-28: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
* Days 29-42: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)
* Days 43-56: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)
|
|---|---|---|---|
|
Weight Loss
|
1.14 Percent weight change
Standard Deviation 2.810
|
-3.77 Percent weight change
Standard Deviation 2.446
|
-4.99 Percent weight change
Standard Deviation 3.410
|
SECONDARY outcome
Timeframe: 56 daysPopulation: The number of subjects with values at both time points (Baseline and Day 56)
Mean change in waist circumference from baseline to Day 56
Outcome measures
| Measure |
VI-0521 Mid Dose
n=13 Participants
* Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 15-56: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
|
VI-0521 Top Dose
n=15 Participants
* Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 15-28: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
* Days 29-42: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)
* Days 43-56: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)
|
VI-0521 Top Dose
n=12 Participants
* Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 15-28: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
* Days 29-42: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)
* Days 43-56: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)
|
|---|---|---|---|
|
Change in Waist Circumference
|
0.1 cm
Standard Deviation 4.17
|
-2.6 cm
Standard Deviation 5.63
|
-4.8 cm
Standard Deviation 4.91
|
SECONDARY outcome
Timeframe: 56 daysPopulation: The number of subjects with values at both time points (Baseline and Day 56)
Mean change in blood pressure from baseline to Day 56
Outcome measures
| Measure |
VI-0521 Mid Dose
n=14 Participants
* Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 15-56: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
|
VI-0521 Top Dose
n=15 Participants
* Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 15-28: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
* Days 29-42: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)
* Days 43-56: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)
|
VI-0521 Top Dose
n=13 Participants
* Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 15-28: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
* Days 29-42: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)
* Days 43-56: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)
|
|---|---|---|---|
|
Change in Blood Pressure
Mean change in systolic BP
|
-6.0 mmHg
Standard Deviation 12.42
|
-3.3 mmHg
Standard Deviation 10.24
|
-3.8 mmHg
Standard Deviation 9.64
|
|
Change in Blood Pressure
Mean change in diastolic BP
|
-2.2 mmHg
Standard Deviation 7.53
|
3.5 mmHg
Standard Deviation 8.11
|
2.1 mmHg
Standard Deviation 6.10
|
SECONDARY outcome
Timeframe: 56 daysPopulation: The number of subjects with values at both time points (Baseline and Day 56)
Mean changes in glycemic parameters (OGTT of fasting and 2-hour glucose) from baseline to Day 56
Outcome measures
| Measure |
VI-0521 Mid Dose
n=14 Participants
* Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 15-56: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
|
VI-0521 Top Dose
n=15 Participants
* Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 15-28: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
* Days 29-42: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)
* Days 43-56: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)
|
VI-0521 Top Dose
n=13 Participants
* Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 15-28: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
* Days 29-42: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)
* Days 43-56: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)
|
|---|---|---|---|
|
Change in OGTT of Fasting and 2-hour Glucose
Mean Change in OGTT of Fasting Serum Glucose
|
-3.2 mg/dL
Standard Deviation 11.66
|
0.6 mg/dL
Standard Deviation 4.65
|
-2.1 mg/dL
Standard Deviation 9.64
|
|
Change in OGTT of Fasting and 2-hour Glucose
Mean Change in OGTT of 2-Hour Serum Glucose
|
-1.2 mg/dL
Standard Deviation 33.23
|
-3.9 mg/dL
Standard Deviation 31.96
|
-9.3 mg/dL
Standard Deviation 16.57
|
|
Change in OGTT of Fasting and 2-hour Glucose
Mean Change in OGTT of Fasting Serum Insulin
|
3.28 mg/dL
Standard Deviation 25.463
|
-10.92 mg/dL
Standard Deviation 31.474
|
-8.03 mg/dL
Standard Deviation 6.500
|
|
Change in OGTT of Fasting and 2-hour Glucose
Mean Change in OGTT of 2-Hour Serum Insulin
|
11.45 mg/dL
Standard Deviation 123.842
|
-54.13 mg/dL
Standard Deviation 176.897
|
-92.99 mg/dL
Standard Deviation 104.468
|
SECONDARY outcome
Timeframe: 56 daysPopulation: The number of subjects with values at both time points (Baseline and Day 56)
Mean percent changes in lipid parameters, including total cholesterol, LDL-C, HDL-C and triglycerides (TG) from baseline to Day 56
Outcome measures
| Measure |
VI-0521 Mid Dose
n=14 Participants
* Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 15-56: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
|
VI-0521 Top Dose
n=15 Participants
* Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 15-28: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
* Days 29-42: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)
* Days 43-56: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)
|
VI-0521 Top Dose
n=13 Participants
* Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 15-28: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
* Days 29-42: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)
* Days 43-56: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)
|
|---|---|---|---|
|
Change in Lipid Parameters
Mean Percent Change in TG
|
7.54 Percent Change
Standard Deviation 42.040
|
0.05 Percent Change
Standard Deviation 58.326
|
-8.05 Percent Change
Standard Deviation 47.167
|
|
Change in Lipid Parameters
Mean Percent Change in TC
|
0.26 Percent Change
Standard Deviation 9.154
|
-6.10 Percent Change
Standard Deviation 10.857
|
-1.73 Percent Change
Standard Deviation 14.103
|
|
Change in Lipid Parameters
Mean Percent Change in LDL-C
|
2.89 Percent Change
Standard Deviation 16.532
|
-4.42 Percent Change
Standard Deviation 13.567
|
8.99 Percent Change
Standard Deviation 26.718
|
|
Change in Lipid Parameters
Mean Percent Change in HDL-C
|
-3.16 Percent Change
Standard Deviation 20.539
|
-6.62 Percent Change
Standard Deviation 9.887
|
-12.55 Percent Change
Standard Deviation 14.248
|
SECONDARY outcome
Timeframe: 56 daysPopulation: The number of subjects with values at both time points (Baseline and Day 56)
Mean change in visual analog scale (VAS) hunger scores from baseline to Day 56. VAS hunger score is measured using a 10.0 cm horizontal line. The left end of this line is defined by word descriptors "not at all hungry" and corresponds to a VAS hunger score of 0.0. The right end of this line is defined by word descriptors "extremely hungry all the time" and corresponds to a VAS hunger score of 10.0. Subjects were asked "Please mark with a perpendicular line on the scale how hungry you were overall during the past week:" to best describes their overall level of hunger during the past week. Research staff measure the distance between the "0.0 = not at all hungry" anchor and the mark made by the subject (length to the nearest tenth of a centimeter) to score the measure.
Outcome measures
| Measure |
VI-0521 Mid Dose
n=13 Participants
* Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 15-56: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
|
VI-0521 Top Dose
n=15 Participants
* Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 15-28: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
* Days 29-42: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)
* Days 43-56: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)
|
VI-0521 Top Dose
n=12 Participants
* Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 15-28: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
* Days 29-42: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)
* Days 43-56: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)
|
|---|---|---|---|
|
Change in Visual Analog Scale (VAS) Hunger Scores
|
-0.48 units on a scale
Standard Deviation 1.975
|
-1.26 units on a scale
Standard Deviation 2.030
|
-3.28 units on a scale
Standard Deviation 2.314
|
SECONDARY outcome
Timeframe: 56 daysPopulation: The number of subjects with values at both time points (Baseline and Day 56)
Mean change in visual analog scale (VAS) satiety scores from baseline to Day 56. VAS satiety score is measured using a 10.0 cm horizontal line. The left end of this line is defined by word descriptors "very satisfied" and corresponds to a VAS satiety score of 0.0. The right end of this line is defined by word descriptors "not all at satisfied" and corresponds to a VAS satiety score of 10.0. Subjects were asked "Please mark with a perpendicular line on the scale how satisfied you were after eating during the past week:" to evaluate how satisfied subjects are after eating during the past week. Research staff measure the distance between the "0.0 = very satisfied" anchor and the mark made by the subject (length to the nearest tenth of a centimeter) to score the measure.
Outcome measures
| Measure |
VI-0521 Mid Dose
n=13 Participants
* Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 15-56: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
|
VI-0521 Top Dose
n=15 Participants
* Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 15-28: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
* Days 29-42: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)
* Days 43-56: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)
|
VI-0521 Top Dose
n=12 Participants
* Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 15-28: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
* Days 29-42: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)
* Days 43-56: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)
|
|---|---|---|---|
|
Change in Visual Analog Scale (VAS) Satiety Scores
|
-0.74 units on a scale
Standard Deviation 2.164
|
-0.65 units on a scale
Standard Deviation 1.758
|
0.18 units on a scale
Standard Deviation 2.221
|
SECONDARY outcome
Timeframe: 56 daysPopulation: The number of subjects with values at both time points (Baseline and Day 56)
Mean changes in glycemic parameters (HOMA-IR) from baseline to Day 56
Outcome measures
| Measure |
VI-0521 Mid Dose
n=13 Participants
* Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 15-56: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
|
VI-0521 Top Dose
n=14 Participants
* Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 15-28: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
* Days 29-42: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)
* Days 43-56: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)
|
VI-0521 Top Dose
n=10 Participants
* Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 15-28: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
* Days 29-42: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)
* Days 43-56: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)
|
|---|---|---|---|
|
Change in HOMA-IR
|
0.65 μIU/mL
Standard Deviation 7.298
|
-2.46 μIU/mL
Standard Deviation 7.513
|
-1.82 μIU/mL
Standard Deviation 1.444
|
SECONDARY outcome
Timeframe: 56 daysPopulation: The number of subjects with values at both time points (Baseline and Day 56)
Mean changes in glycemic parameters \[Whole Body Insulin Sensitivity Index (WBISI) (Matsuda)\] from baseline to Day 56. The Oral Glucose Tolerance Test (OGTT) were performed at Baseline and Day 56 using 75 g oral glucose load; blood samples were obtained at baseline and at 2 hours post glucose load for evaluation of both glucose and insulin levels. Insulin Sensitivity was measured by obtaining glucose and insulin levels in a fasting state and at 2 hours after administration of oral glucose load. Matsuda index = 10,000/SQRT \[glucose concentration (mg/dL) (fasting)\*insulin concentration (uIU/mL) (fasting)\*glucose concentration (mg/dL) (2 hours after glucose load)\*insulin concentration (uIU/ mL) (2 hours after glucose load)\], with higher numbers indicating better insulin sensitivity.
Outcome measures
| Measure |
VI-0521 Mid Dose
n=13 Participants
* Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 15-56: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
|
VI-0521 Top Dose
n=13 Participants
* Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 15-28: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
* Days 29-42: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)
* Days 43-56: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)
|
VI-0521 Top Dose
n=10 Participants
* Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 15-28: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
* Days 29-42: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)
* Days 43-56: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)
|
|---|---|---|---|
|
Change in Whole Body Insulin Sensitivity Index (WBISI) (Matsuda)
|
-0.19 Index
Standard Deviation 1.758
|
0.55 Index
Standard Deviation 1.226
|
2.13 Index
Standard Deviation 2.921
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
VI-0521 Mid Dose
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
VI-0521 Top Dose
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=14 participants at risk
Placebo: Placebo, po once daily
|
VI-0521 Mid Dose
n=15 participants at risk
VI-0521 Mid Dose: phentermine 7.5 mg and topiramate 46 mg, po once daily
|
VI-0521 Top Dose
n=13 participants at risk
VI-0521 Top Dose: phentermine 15 mg and topiramate 92 mg, po once daily
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/14
|
0.00%
0/15
|
7.7%
1/13 • Number of events 1
|
Other adverse events
| Measure |
Placebo
n=14 participants at risk
Placebo: Placebo, po once daily
|
VI-0521 Mid Dose
n=15 participants at risk
VI-0521 Mid Dose: phentermine 7.5 mg and topiramate 46 mg, po once daily
|
VI-0521 Top Dose
n=13 participants at risk
VI-0521 Top Dose: phentermine 15 mg and topiramate 92 mg, po once daily
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
21.4%
3/14
|
13.3%
2/15
|
15.4%
2/13
|
|
Nervous system disorders
Paraesthesia
|
7.1%
1/14
|
0.00%
0/15
|
30.8%
4/13
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/14
|
0.00%
0/15
|
15.4%
2/13
|
|
Nervous system disorders
Dizziness
|
7.1%
1/14
|
0.00%
0/15
|
0.00%
0/13
|
|
Nervous system disorders
Migraine
|
0.00%
0/14
|
0.00%
0/15
|
7.7%
1/13
|
|
Nervous system disorders
Poor quality sleep
|
0.00%
0/14
|
0.00%
0/15
|
7.7%
1/13
|
|
Nervous system disorders
Syncope
|
0.00%
0/14
|
0.00%
0/15
|
7.7%
1/13
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/14
|
6.7%
1/15
|
7.7%
1/13
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/14
|
6.7%
1/15
|
0.00%
0/13
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/14
|
6.7%
1/15
|
0.00%
0/13
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/14
|
0.00%
0/15
|
7.7%
1/13
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/14
|
6.7%
1/15
|
0.00%
0/13
|
|
Infections and infestations
Ear infection
|
0.00%
0/14
|
6.7%
1/15
|
0.00%
0/13
|
|
Infections and infestations
Nasopharyngitis
|
7.1%
1/14
|
0.00%
0/15
|
0.00%
0/13
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/14
|
6.7%
1/15
|
0.00%
0/13
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.1%
1/14
|
0.00%
0/15
|
15.4%
2/13
|
|
Psychiatric disorders
Insomnia
|
7.1%
1/14
|
6.7%
1/15
|
0.00%
0/13
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/14
|
0.00%
0/15
|
7.7%
1/13
|
|
General disorders
Fatigue
|
0.00%
0/14
|
0.00%
0/15
|
7.7%
1/13
|
|
General disorders
Influenza like illness
|
0.00%
0/14
|
0.00%
0/15
|
7.7%
1/13
|
|
Investigations
Urine analysis abnormal
|
0.00%
0/14
|
0.00%
0/15
|
7.7%
1/13
|
|
Investigations
Urine osmolarity increased
|
0.00%
0/14
|
6.7%
1/15
|
0.00%
0/13
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/14
|
6.7%
1/15
|
0.00%
0/13
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/14
|
0.00%
0/15
|
7.7%
1/13
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/14
|
0.00%
0/15
|
7.7%
1/13
|
|
Eye disorders
Vision blurred
|
0.00%
0/14
|
0.00%
0/15
|
7.7%
1/13
|
|
Injury, poisoning and procedural complications
Procedural pain
|
7.1%
1/14
|
0.00%
0/15
|
0.00%
0/13
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.1%
1/14
|
0.00%
0/15
|
0.00%
0/13
|
Additional Information
Sr. Director, Clinical Research
VIVUS
Phone: 650-934-5200
Results disclosure agreements
- Principal investigator is a sponsor employee The PI may publish the result of the study 12 months or longer after termination of the study. The PI will provide the sponsor a copy of any proposed publication at least 30 days prior to submission for publication.
- Publication restrictions are in place
Restriction type: OTHER