Trial Outcomes & Findings for Effect of VI-0521 (Qsymia®) on Glomerular Filtration Rate (GFR) in Overweight or Obese Healthy Subjects (NCT NCT02229214)
NCT ID: NCT02229214
Last Updated: 2017-11-07
Results Overview
Method that uses iohexol clearance and body surface area to measure kidney function. Iohexol is an FDA-approved non-radioactive iodine-containing substance widely used in radio-imaging procedures and as a marker for the measurement of in GFR.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
51 participants
Primary outcome timeframe
Baseline, end of treatment
Results posted on
2017-11-07
Participant Flow
Participant milestones
| Measure |
VI-0521 (Qsymia)
* Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
* Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)
* Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)
Qsymia
|
Placebo
Days 1-28: Placebo
Sugar Pill
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
10
|
|
Overall Study
COMPLETED
|
35
|
10
|
|
Overall Study
NOT COMPLETED
|
6
|
0
|
Reasons for withdrawal
| Measure |
VI-0521 (Qsymia)
* Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
* Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)
* Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)
Qsymia
|
Placebo
Days 1-28: Placebo
Sugar Pill
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
0
|
Baseline Characteristics
Effect of VI-0521 (Qsymia®) on Glomerular Filtration Rate (GFR) in Overweight or Obese Healthy Subjects
Baseline characteristics by cohort
| Measure |
VI-0521 (Qsymia)
n=41 Participants
* Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
* Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)
* Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)
Qsymia
|
Placebo
n=10 Participants
Days 1-28: Placebo
Placebo (sugar pill)
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.4 Years
STANDARD_DEVIATION 11.07 • n=99 Participants
|
37.6 Years
STANDARD_DEVIATION 9.80 • n=107 Participants
|
38.2 Years
STANDARD_DEVIATION 10.74 • n=206 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
41 participants
n=99 Participants
|
10 participants
n=107 Participants
|
51 participants
n=206 Participants
|
|
BMI
|
33.2 Kg/m^2
STANDARD_DEVIATION 4.72 • n=99 Participants
|
31.3 Kg/m^2
STANDARD_DEVIATION 2.81 • n=107 Participants
|
32.8 Kg/m^2
STANDARD_DEVIATION 4.46 • n=206 Participants
|
|
iGFR
|
95.1 mL/min/1.73m^2
STANDARD_DEVIATION 14.05 • n=99 Participants
|
87.3 mL/min/1.73m^2
STANDARD_DEVIATION 9.06 • n=107 Participants
|
93.6 mL/min/1.73m^2
STANDARD_DEVIATION 13.49 • n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, end of treatmentPopulation: The number analyzed in this outcome measure are those subjects who have both baseline and end of treatment iGFR measurements.
Method that uses iohexol clearance and body surface area to measure kidney function. Iohexol is an FDA-approved non-radioactive iodine-containing substance widely used in radio-imaging procedures and as a marker for the measurement of in GFR.
Outcome measures
| Measure |
VI-0521 (Qsymia)
n=34 Participants
* Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
* Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)
* Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)
Qsymia
|
Placebo
n=10 Participants
Days 1-28: Placebo
Sugar Pill
|
|---|---|---|
|
Change in iGFR (Glomerular Filtration Rate as Measured by Iohexol Clearance) From Baseline to End of Treatment
|
-14.92 mL/min/1.73 m^2
Standard Error 1.28
|
1.08 mL/min/1.73 m^2
Standard Error 2.28
|
PRIMARY outcome
Timeframe: Baseline, 28 days after end of treatmentPopulation: The number analyzed in this outcome measure are those subjects who have both baseline and 28 days after treatment iGFR measurements.
Method that uses iohexol clearance and body surface area to measure kidney function. Iohexol is an FDA-approved non-radioactive iodine-containing substance widely used in radio-imaging procedures and as a marker for the measurement of in GFR
Outcome measures
| Measure |
VI-0521 (Qsymia)
n=32 Participants
* Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
* Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)
* Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)
Qsymia
|
Placebo
n=10 Participants
Days 1-28: Placebo
Sugar Pill
|
|---|---|---|
|
Change in iGFR (Glomerular Filtration Rate as Measured by Iohexol Clearance) From Baseline to 28 Days After End of Treatment
|
-3.75 mL/min/1.73 m^2
Standard Error 1.49
|
2.34 mL/min/1.73 m^2
Standard Error 1.34
|
SECONDARY outcome
Timeframe: Baseline, end of treatmentPopulation: The number analyzed in this outcome measure are those subjects who have both baseline and end of treatment serum creatininine measurements
Outcome measures
| Measure |
VI-0521 (Qsymia)
n=35 Participants
* Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
* Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)
* Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)
Qsymia
|
Placebo
n=10 Participants
Days 1-28: Placebo
Sugar Pill
|
|---|---|---|
|
Change in Serum Creatinine From Baseline to End of Treatment
|
0.10 mg/dL
Standard Error 0.01
|
0.03 mg/dL
Standard Error 0.03
|
SECONDARY outcome
Timeframe: Baseline, 28 days after end of treatmentPopulation: The number analyzed in this outcome measure are those subjects who have both baseline and 28 days after end of treatment serum creatinine measurements.
Outcome measures
| Measure |
VI-0521 (Qsymia)
n=35 Participants
* Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
* Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)
* Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)
Qsymia
|
Placebo
n=10 Participants
Days 1-28: Placebo
Sugar Pill
|
|---|---|---|
|
Change in Serum Creatinine From Baseline to 28 Days After End of Treatment
|
-0.01 mg/dL
Standard Error 0.01
|
0.03 mg/dL
Standard Error 0.02
|
SECONDARY outcome
Timeframe: Baseline, end of treatmentPopulation: The number analyzed in this outcome measure are those subjects who have both baseline and end of treatment cystatin C measurements.
Outcome measures
| Measure |
VI-0521 (Qsymia)
n=35 Participants
* Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
* Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)
* Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)
Qsymia
|
Placebo
n=10 Participants
Days 1-28: Placebo
Sugar Pill
|
|---|---|---|
|
Change in Cystatin C From Baseline to End of Treatment
|
0.04 mg/L
Standard Error 0.01
|
0.03 mg/L
Standard Error 0.02
|
SECONDARY outcome
Timeframe: Baseline, 28 days after end of treatmentPopulation: The number analyzed in this outcome measure are those subjects who have both baseline and 28 days after end of treatment cystatin C measurements.
Outcome measures
| Measure |
VI-0521 (Qsymia)
n=35 Participants
* Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
* Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)
* Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)
Qsymia
|
Placebo
n=10 Participants
Days 1-28: Placebo
Sugar Pill
|
|---|---|---|
|
Change in Cystatin C From Baseline to 28 Days After End of Treatment
|
0.01 mg/L
Standard Error 0.01
|
0.02 mg/L
Standard Error 0.01
|
SECONDARY outcome
Timeframe: Baseline, end of treatmentOutcome measures
| Measure |
VI-0521 (Qsymia)
n=41 Participants
* Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
* Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)
* Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)
Qsymia
|
Placebo
n=10 Participants
Days 1-28: Placebo
Sugar Pill
|
|---|---|---|
|
Percentage of Subjects With a Decrease of >/= 15% in Iohexol Clearance From Baseline to End of Treatment
|
48.8 percent of participants
|
0 percent of participants
|
SECONDARY outcome
Timeframe: Baseline, 28 days after end of treatmentOutcome measures
| Measure |
VI-0521 (Qsymia)
n=41 Participants
* Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
* Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)
* Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)
Qsymia
|
Placebo
n=10 Participants
Days 1-28: Placebo
Sugar Pill
|
|---|---|---|
|
Percentage of Subjects With a Decrease of >/= 15% in Iohexol Clearance From Baseline to 28 Days After End of Treatment
|
7.3 percent of participants
|
0 percent of participants
|
Adverse Events
VI-0521 (Qsymia)
Serious events: 1 serious events
Other events: 33 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
VI-0521 (Qsymia)
n=41 participants at risk
* Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
* Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)
* Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)
Qsymia
|
Placebo
n=10 participants at risk
Days 1-28: Placebo
Sugar Pill
|
|---|---|---|
|
Injury, poisoning and procedural complications
Fall
|
2.4%
1/41 • Number of events 1 • 3 months
|
0.00%
0/10 • 3 months
|
Other adverse events
| Measure |
VI-0521 (Qsymia)
n=41 participants at risk
* Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)
* Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
* Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)
* Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)
Qsymia
|
Placebo
n=10 participants at risk
Days 1-28: Placebo
Sugar Pill
|
|---|---|---|
|
Eye disorders
Ocular Hyperaemia
|
0.00%
0/41 • 3 months
|
10.0%
1/10 • 3 months
|
|
Gastrointestinal disorders
Dry mouth
|
12.2%
5/41 • 3 months
|
0.00%
0/10 • 3 months
|
|
Gastrointestinal disorders
Nausea
|
9.8%
4/41 • 3 months
|
10.0%
1/10 • 3 months
|
|
Gastrointestinal disorders
Paraesthesia Oral
|
7.3%
3/41 • 3 months
|
0.00%
0/10 • 3 months
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/41 • 3 months
|
20.0%
2/10 • 3 months
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
9.8%
4/41 • 3 months
|
0.00%
0/10 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
2.4%
1/41 • 3 months
|
10.0%
1/10 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/41 • 3 months
|
10.0%
1/10 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/41 • 3 months
|
10.0%
1/10 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/41 • 3 months
|
10.0%
1/10 • 3 months
|
|
Nervous system disorders
Paraesthesia
|
29.3%
12/41 • 3 months
|
0.00%
0/10 • 3 months
|
|
Nervous system disorders
Headache
|
22.0%
9/41 • 3 months
|
20.0%
2/10 • 3 months
|
|
Nervous system disorders
Dizziness
|
17.1%
7/41 • 3 months
|
0.00%
0/10 • 3 months
|
|
Psychiatric disorders
Insomnia
|
12.2%
5/41 • 3 months
|
0.00%
0/10 • 3 months
|
|
Reproductive system and breast disorders
Dysfunctional Uterine Bleeding
|
2.4%
1/41 • 3 months
|
10.0%
1/10 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.9%
2/41 • 3 months
|
10.0%
1/10 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
0.00%
0/41 • 3 months
|
10.0%
1/10 • 3 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/41 • 3 months
|
10.0%
1/10 • 3 months
|
Additional Information
Craig Peterson, Sr. Director, Clinical Research
VIVUS Inc.
Phone: 650-934-5200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60