Trial Outcomes & Findings for A Phase IV Safety and Efficacy Study of VI-0521 in Adolescents With Obesity (NCT NCT03922945)
NCT ID: NCT03922945
Last Updated: 2022-09-10
Results Overview
Mean % change in BMI from Baseline to Week 56
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
223 participants
Primary outcome timeframe
Baseline to Week 56
Results posted on
2022-09-10
Participant Flow
The study was conducted at 26 study sites in the United States.
The study consisted of a Screening period of up to 28 days. Once confirmed participant meeting all study criteria, including laboratory values, participants were randomized to either placebo, Mid-dose, or Top-dose of VI-0521 (phentermine/topiramate \[PHEN/TPM\]), for a 56-week treatment period.
Participant milestones
| Measure |
Placebo
Weeks 1-56: Placebo (Inactive drug) oral capsule, once daily; Weeks 1-56: Lifestyle Modification
|
VI-0521 Mid Dose
Weeks 1-2: VI-0521 (PHEN/TPM 3.75 mg/23 mg) oral capsule, once daily; Weeks 3-56: VI-0521 (PHEN/TPM 7.5 mg/46 mg) oral capsule, once daily; Weeks 1-56: Lifestyle Modification
|
VI-0521 Top Dose
Weeks 1-2: VI-0521 (PHEN/TPM 3.75 mg/23 mg) oral capsule, once daily; Weeks 3-12: VI-0521 (PHEN/TPM 7.5 mg/46 mg) oral capsule, once daily; Weeks 13-14: VI-0521 (PHEN/TPM 11.25 mg/69 mg) oral capsule, once daily; Weeks 15-56: VI-0521 (PHEN/TPM 15 mg/92 mg) oral capsule, once daily; Weeks 1-56: Lifestyle Modification
|
|---|---|---|---|
|
Overall Study
STARTED
|
56
|
54
|
113
|
|
Overall Study
COMPLETED
|
29
|
37
|
73
|
|
Overall Study
NOT COMPLETED
|
27
|
17
|
40
|
Reasons for withdrawal
| Measure |
Placebo
Weeks 1-56: Placebo (Inactive drug) oral capsule, once daily; Weeks 1-56: Lifestyle Modification
|
VI-0521 Mid Dose
Weeks 1-2: VI-0521 (PHEN/TPM 3.75 mg/23 mg) oral capsule, once daily; Weeks 3-56: VI-0521 (PHEN/TPM 7.5 mg/46 mg) oral capsule, once daily; Weeks 1-56: Lifestyle Modification
|
VI-0521 Top Dose
Weeks 1-2: VI-0521 (PHEN/TPM 3.75 mg/23 mg) oral capsule, once daily; Weeks 3-12: VI-0521 (PHEN/TPM 7.5 mg/46 mg) oral capsule, once daily; Weeks 13-14: VI-0521 (PHEN/TPM 11.25 mg/69 mg) oral capsule, once daily; Weeks 15-56: VI-0521 (PHEN/TPM 15 mg/92 mg) oral capsule, once daily; Weeks 1-56: Lifestyle Modification
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
13
|
9
|
20
|
|
Overall Study
Lack of Efficacy
|
2
|
0
|
1
|
|
Overall Study
Protocol Non-Compliance
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject / Parent / Legal Guardian
|
10
|
6
|
14
|
|
Overall Study
All Other Personal Reasons
|
1
|
1
|
2
|
Baseline Characteristics
A Phase IV Safety and Efficacy Study of VI-0521 in Adolescents With Obesity
Baseline characteristics by cohort
| Measure |
Placebo
n=56 Participants
Weeks 1-56: Placebo (Inactive drug) oral capsule, once daily; Weeks 1-56: Lifestyle Modification
|
VI-0521 Mid Dose
n=54 Participants
Weeks 1-2: VI-0521 (PHEN/TPM 3.75 mg/23 mg) oral capsule, once daily; Weeks 3-56: VI-0521 (PHEN/TPM 7.5 mg/46 mg) oral capsule, once daily; Weeks 1-56: Lifestyle Modification
|
VI-0521 Top Dose
n=113 Participants
Weeks 1-2: VI-0521 (PHEN/TPM 3.75 mg/23 mg) oral capsule, once daily; Weeks 3-12: VI-0521 (PHEN/TPM 7.5 mg/46 mg) oral capsule, once daily; Weeks 13-14: VI-0521 (PHEN/TPM 11.25 mg/69 mg) oral capsule, once daily; Weeks 15-56: VI-0521 (PHEN/TPM 15 mg/92 mg) oral capsule, once daily; Weeks 1-56: Lifestyle Modification
|
Total
n=223 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
14.0 years
n=39 Participants
|
14.1 years
n=41 Participants
|
13.9 years
n=35 Participants
|
14.0 years
n=31 Participants
|
|
Age, Customized
12-14 Years
|
34 Participants
n=39 Participants
|
33 Participants
n=41 Participants
|
69 Participants
n=35 Participants
|
136 Participants
n=31 Participants
|
|
Age, Customized
15-16 Years
|
22 Participants
n=39 Participants
|
21 Participants
n=41 Participants
|
44 Participants
n=35 Participants
|
87 Participants
n=31 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=39 Participants
|
28 Participants
n=41 Participants
|
63 Participants
n=35 Participants
|
121 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=39 Participants
|
26 Participants
n=41 Participants
|
50 Participants
n=35 Participants
|
102 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=39 Participants
|
25 Participants
n=41 Participants
|
34 Participants
n=35 Participants
|
72 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=39 Participants
|
28 Participants
n=41 Participants
|
79 Participants
n=35 Participants
|
149 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
White
|
42 Participants
n=39 Participants
|
36 Participants
n=41 Participants
|
71 Participants
n=35 Participants
|
149 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
10 Participants
n=39 Participants
|
14 Participants
n=41 Participants
|
36 Participants
n=35 Participants
|
60 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
12 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
56 participants
n=39 Participants
|
54 participants
n=41 Participants
|
113 participants
n=35 Participants
|
223 participants
n=31 Participants
|
|
BMI Categories
≥95th to <99th percentile
|
26 Participants
n=39 Participants
|
23 Participants
n=41 Participants
|
33 Participants
n=35 Participants
|
82 Participants
n=31 Participants
|
|
BMI Categories
≥99th percentile
|
30 Participants
n=39 Participants
|
30 Participants
n=41 Participants
|
79 Participants
n=35 Participants
|
139 Participants
n=31 Participants
|
|
BMI Categories
Missing
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 56Mean % change in BMI from Baseline to Week 56
Outcome measures
| Measure |
Placebo
n=56 Participants
Weeks 1-56: Placebo (Inactive drug) oral capsule, once daily; Weeks 1-56: Lifestyle Modification
|
VI-0521 Mid Dose
n=54 Participants
Weeks 1-2: VI-0521 (PHEN/TPM 3.75 mg/23 mg) oral capsule, once daily; Weeks 3-56: VI-0521 (PHEN/TPM 7.5 mg/46 mg) oral capsule, once daily; Weeks 1-56: Lifestyle Modification
|
VI-0521 Top Dose
n=113 Participants
Weeks 1-2: VI-0521 (PHEN/TPM 3.75 mg/23 mg) oral capsule, once daily; Weeks 3-12: VI-0521 (PHEN/TPM 7.5 mg/46 mg) oral capsule, once daily; Weeks 13-14: VI-0521 (PHEN/TPM 11.25 mg/69 mg) oral capsule, once daily; Weeks 15-56: VI-0521 (PHEN/TPM 15 mg/92 mg) oral capsule, once daily; Weeks 1-56: Lifestyle Modification
|
|---|---|---|---|
|
Mean % Change in Body Mass Index (BMI)
|
3.34 Percentage Change
Standard Error 1.441
|
-4.78 Percentage Change
Standard Error 1.302
|
-7.11 Percentage Change
Standard Error 1.011
|
SECONDARY outcome
Timeframe: Baseline to Week 56Outcome measures
| Measure |
Placebo
n=56 Participants
Weeks 1-56: Placebo (Inactive drug) oral capsule, once daily; Weeks 1-56: Lifestyle Modification
|
VI-0521 Mid Dose
n=54 Participants
Weeks 1-2: VI-0521 (PHEN/TPM 3.75 mg/23 mg) oral capsule, once daily; Weeks 3-56: VI-0521 (PHEN/TPM 7.5 mg/46 mg) oral capsule, once daily; Weeks 1-56: Lifestyle Modification
|
VI-0521 Top Dose
n=113 Participants
Weeks 1-2: VI-0521 (PHEN/TPM 3.75 mg/23 mg) oral capsule, once daily; Weeks 3-12: VI-0521 (PHEN/TPM 7.5 mg/46 mg) oral capsule, once daily; Weeks 13-14: VI-0521 (PHEN/TPM 11.25 mg/69 mg) oral capsule, once daily; Weeks 15-56: VI-0521 (PHEN/TPM 15 mg/92 mg) oral capsule, once daily; Weeks 1-56: Lifestyle Modification
|
|---|---|---|---|
|
Percentage of Subjects Achieving at Least 5% BMI Reduction at Week 56
|
13.6 percentage of participants
|
44 percentage of participants
|
52.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 56Outcome measures
| Measure |
Placebo
n=56 Participants
Weeks 1-56: Placebo (Inactive drug) oral capsule, once daily; Weeks 1-56: Lifestyle Modification
|
VI-0521 Mid Dose
n=54 Participants
Weeks 1-2: VI-0521 (PHEN/TPM 3.75 mg/23 mg) oral capsule, once daily; Weeks 3-56: VI-0521 (PHEN/TPM 7.5 mg/46 mg) oral capsule, once daily; Weeks 1-56: Lifestyle Modification
|
VI-0521 Top Dose
n=113 Participants
Weeks 1-2: VI-0521 (PHEN/TPM 3.75 mg/23 mg) oral capsule, once daily; Weeks 3-12: VI-0521 (PHEN/TPM 7.5 mg/46 mg) oral capsule, once daily; Weeks 13-14: VI-0521 (PHEN/TPM 11.25 mg/69 mg) oral capsule, once daily; Weeks 15-56: VI-0521 (PHEN/TPM 15 mg/92 mg) oral capsule, once daily; Weeks 1-56: Lifestyle Modification
|
|---|---|---|---|
|
Percentage of Subjects Achieving at Least 10% BMI Reduction at Week 56
|
4.5 percentage of participants
|
33.5 percentage of participants
|
44.4 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Week 56Outcome measures
| Measure |
Placebo
n=56 Participants
Weeks 1-56: Placebo (Inactive drug) oral capsule, once daily; Weeks 1-56: Lifestyle Modification
|
VI-0521 Mid Dose
n=54 Participants
Weeks 1-2: VI-0521 (PHEN/TPM 3.75 mg/23 mg) oral capsule, once daily; Weeks 3-56: VI-0521 (PHEN/TPM 7.5 mg/46 mg) oral capsule, once daily; Weeks 1-56: Lifestyle Modification
|
VI-0521 Top Dose
n=113 Participants
Weeks 1-2: VI-0521 (PHEN/TPM 3.75 mg/23 mg) oral capsule, once daily; Weeks 3-12: VI-0521 (PHEN/TPM 7.5 mg/46 mg) oral capsule, once daily; Weeks 13-14: VI-0521 (PHEN/TPM 11.25 mg/69 mg) oral capsule, once daily; Weeks 15-56: VI-0521 (PHEN/TPM 15 mg/92 mg) oral capsule, once daily; Weeks 1-56: Lifestyle Modification
|
|---|---|---|---|
|
Percentage of Subjects Achieving at Least 15% BMI Reduction at Week 56
|
2.9 percentage of participants
|
13.6 percentage of participants
|
28.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 56Change in waist circumference from Baseline to Week 56
Outcome measures
| Measure |
Placebo
n=56 Participants
Weeks 1-56: Placebo (Inactive drug) oral capsule, once daily; Weeks 1-56: Lifestyle Modification
|
VI-0521 Mid Dose
n=54 Participants
Weeks 1-2: VI-0521 (PHEN/TPM 3.75 mg/23 mg) oral capsule, once daily; Weeks 3-56: VI-0521 (PHEN/TPM 7.5 mg/46 mg) oral capsule, once daily; Weeks 1-56: Lifestyle Modification
|
VI-0521 Top Dose
n=113 Participants
Weeks 1-2: VI-0521 (PHEN/TPM 3.75 mg/23 mg) oral capsule, once daily; Weeks 3-12: VI-0521 (PHEN/TPM 7.5 mg/46 mg) oral capsule, once daily; Weeks 13-14: VI-0521 (PHEN/TPM 11.25 mg/69 mg) oral capsule, once daily; Weeks 15-56: VI-0521 (PHEN/TPM 15 mg/92 mg) oral capsule, once daily; Weeks 1-56: Lifestyle Modification
|
|---|---|---|---|
|
Change in Waist Circumference at Week 56
|
0.61 Centimeter
Standard Error 1.397
|
-5.03 Centimeter
Standard Error 1.376
|
-6.98 Centimeter
Standard Error 1.072
|
SECONDARY outcome
Timeframe: Baseline, Week 56Population: The number of subjects with values at both time points (Baseline and Week 56)
Mean changes in glycemic parameters \[Whole Body Insulin Sensitivity Index (WBISI) (Matsuda)\] from baseline to Week 56. The Oral Glucose Tolerance Test (OGTT) were performed at Baseline and Week 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 |
Placebo
n=56 Participants
Weeks 1-56: Placebo (Inactive drug) oral capsule, once daily; Weeks 1-56: Lifestyle Modification
|
VI-0521 Mid Dose
n=54 Participants
Weeks 1-2: VI-0521 (PHEN/TPM 3.75 mg/23 mg) oral capsule, once daily; Weeks 3-56: VI-0521 (PHEN/TPM 7.5 mg/46 mg) oral capsule, once daily; Weeks 1-56: Lifestyle Modification
|
VI-0521 Top Dose
n=113 Participants
Weeks 1-2: VI-0521 (PHEN/TPM 3.75 mg/23 mg) oral capsule, once daily; Weeks 3-12: VI-0521 (PHEN/TPM 7.5 mg/46 mg) oral capsule, once daily; Weeks 13-14: VI-0521 (PHEN/TPM 11.25 mg/69 mg) oral capsule, once daily; Weeks 15-56: VI-0521 (PHEN/TPM 15 mg/92 mg) oral capsule, once daily; Weeks 1-56: Lifestyle Modification
|
|---|---|---|---|
|
Change in Whole Body Insulin Sensitivity Index (WBISI) (Matsuda) at Week 56
|
-3.7 Index
Standard Error 8.887
|
-3.93 Index
Standard Error 7.647
|
-2.99 Index
Standard Error 6.445
|
SECONDARY outcome
Timeframe: Baseline, Week 56Change in fasting insulin from Baseline to Week 56
Outcome measures
| Measure |
Placebo
n=56 Participants
Weeks 1-56: Placebo (Inactive drug) oral capsule, once daily; Weeks 1-56: Lifestyle Modification
|
VI-0521 Mid Dose
n=54 Participants
Weeks 1-2: VI-0521 (PHEN/TPM 3.75 mg/23 mg) oral capsule, once daily; Weeks 3-56: VI-0521 (PHEN/TPM 7.5 mg/46 mg) oral capsule, once daily; Weeks 1-56: Lifestyle Modification
|
VI-0521 Top Dose
n=113 Participants
Weeks 1-2: VI-0521 (PHEN/TPM 3.75 mg/23 mg) oral capsule, once daily; Weeks 3-12: VI-0521 (PHEN/TPM 7.5 mg/46 mg) oral capsule, once daily; Weeks 13-14: VI-0521 (PHEN/TPM 11.25 mg/69 mg) oral capsule, once daily; Weeks 15-56: VI-0521 (PHEN/TPM 15 mg/92 mg) oral capsule, once daily; Weeks 1-56: Lifestyle Modification
|
|---|---|---|---|
|
Change in Fasting Insulin at Week 56
|
-3.32 uIU/mL
Standard Error 8.956
|
-11.47 uIU/mL
Standard Error 7.433
|
-7.99 uIU/mL
Standard Error 6.299
|
SECONDARY outcome
Timeframe: Baseline, Week 56Outcome measures
| Measure |
Placebo
n=56 Participants
Weeks 1-56: Placebo (Inactive drug) oral capsule, once daily; Weeks 1-56: Lifestyle Modification
|
VI-0521 Mid Dose
n=54 Participants
Weeks 1-2: VI-0521 (PHEN/TPM 3.75 mg/23 mg) oral capsule, once daily; Weeks 3-56: VI-0521 (PHEN/TPM 7.5 mg/46 mg) oral capsule, once daily; Weeks 1-56: Lifestyle Modification
|
VI-0521 Top Dose
n=113 Participants
Weeks 1-2: VI-0521 (PHEN/TPM 3.75 mg/23 mg) oral capsule, once daily; Weeks 3-12: VI-0521 (PHEN/TPM 7.5 mg/46 mg) oral capsule, once daily; Weeks 13-14: VI-0521 (PHEN/TPM 11.25 mg/69 mg) oral capsule, once daily; Weeks 15-56: VI-0521 (PHEN/TPM 15 mg/92 mg) oral capsule, once daily; Weeks 1-56: Lifestyle Modification
|
|---|---|---|---|
|
Percent Change in Triglycerides From Baseline to Week 56
|
5.56 Percent Change
Standard Error 8.407
|
-6.18 Percent Change
Standard Error 7.958
|
-5.59 Percent Change
Standard Error 7.17
|
SECONDARY outcome
Timeframe: Baseline, Week 56Outcome measures
| Measure |
Placebo
n=56 Participants
Weeks 1-56: Placebo (Inactive drug) oral capsule, once daily; Weeks 1-56: Lifestyle Modification
|
VI-0521 Mid Dose
n=54 Participants
Weeks 1-2: VI-0521 (PHEN/TPM 3.75 mg/23 mg) oral capsule, once daily; Weeks 3-56: VI-0521 (PHEN/TPM 7.5 mg/46 mg) oral capsule, once daily; Weeks 1-56: Lifestyle Modification
|
VI-0521 Top Dose
n=113 Participants
Weeks 1-2: VI-0521 (PHEN/TPM 3.75 mg/23 mg) oral capsule, once daily; Weeks 3-12: VI-0521 (PHEN/TPM 7.5 mg/46 mg) oral capsule, once daily; Weeks 13-14: VI-0521 (PHEN/TPM 11.25 mg/69 mg) oral capsule, once daily; Weeks 15-56: VI-0521 (PHEN/TPM 15 mg/92 mg) oral capsule, once daily; Weeks 1-56: Lifestyle Modification
|
|---|---|---|---|
|
Percent Change in HDL-C From Baseline to Week 56
|
-4.3 Percent Change
Standard Error 15.1
|
2.11 Percent Change
Standard Error 11.501
|
0.65 Percent Change
Standard Error 9.561
|
SECONDARY outcome
Timeframe: Baseline, Week 56Outcome measures
| Measure |
Placebo
n=56 Participants
Weeks 1-56: Placebo (Inactive drug) oral capsule, once daily; Weeks 1-56: Lifestyle Modification
|
VI-0521 Mid Dose
n=54 Participants
Weeks 1-2: VI-0521 (PHEN/TPM 3.75 mg/23 mg) oral capsule, once daily; Weeks 3-56: VI-0521 (PHEN/TPM 7.5 mg/46 mg) oral capsule, once daily; Weeks 1-56: Lifestyle Modification
|
VI-0521 Top Dose
n=113 Participants
Weeks 1-2: VI-0521 (PHEN/TPM 3.75 mg/23 mg) oral capsule, once daily; Weeks 3-12: VI-0521 (PHEN/TPM 7.5 mg/46 mg) oral capsule, once daily; Weeks 13-14: VI-0521 (PHEN/TPM 11.25 mg/69 mg) oral capsule, once daily; Weeks 15-56: VI-0521 (PHEN/TPM 15 mg/92 mg) oral capsule, once daily; Weeks 1-56: Lifestyle Modification
|
|---|---|---|---|
|
Change From Baseline in Systolic Blood Pressure at Week 56
|
2.86 mmHg
Standard Error 1.63
|
0.09 mmHg
Standard Error 1.503
|
1.84 mmHg
Standard Error 1.111
|
SECONDARY outcome
Timeframe: Baseline, Week 56Outcome measures
| Measure |
Placebo
n=56 Participants
Weeks 1-56: Placebo (Inactive drug) oral capsule, once daily; Weeks 1-56: Lifestyle Modification
|
VI-0521 Mid Dose
n=54 Participants
Weeks 1-2: VI-0521 (PHEN/TPM 3.75 mg/23 mg) oral capsule, once daily; Weeks 3-56: VI-0521 (PHEN/TPM 7.5 mg/46 mg) oral capsule, once daily; Weeks 1-56: Lifestyle Modification
|
VI-0521 Top Dose
n=113 Participants
Weeks 1-2: VI-0521 (PHEN/TPM 3.75 mg/23 mg) oral capsule, once daily; Weeks 3-12: VI-0521 (PHEN/TPM 7.5 mg/46 mg) oral capsule, once daily; Weeks 13-14: VI-0521 (PHEN/TPM 11.25 mg/69 mg) oral capsule, once daily; Weeks 15-56: VI-0521 (PHEN/TPM 15 mg/92 mg) oral capsule, once daily; Weeks 1-56: Lifestyle Modification
|
|---|---|---|---|
|
Change From Baseline in Diastolic Blood Pressure at Week 56
|
3.41 mmHg
Standard Error 1.51
|
0.24 mmHg
Standard Error 1.322
|
1.22 mmHg
Standard Error 0.989
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
VI-0521 Mid Dose
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
VI-0521 Top Dose
Serious events: 2 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=56 participants at risk
Weeks 1-56: Placebo (Inactive drug) oral capsule, once daily; Weeks 1-56: Lifestyle Modification
|
VI-0521 Mid Dose
n=54 participants at risk
Weeks 1-2: VI-0521 (PHEN/TPM 3.75 mg/23 mg) oral capsule, once daily; Weeks 3-56: VI-0521 (PHEN/TPM 7.5 mg/46 mg) oral capsule, once daily; Weeks 1-56: Lifestyle Modification
|
VI-0521 Top Dose
n=113 participants at risk
Weeks 1-2: VI-0521 (PHEN/TPM 3.75 mg/23 mg) oral capsule, once daily; Weeks 3-12: VI-0521 (PHEN/TPM 7.5 mg/46 mg) oral capsule, once daily; Weeks 13-14: VI-0521 (PHEN/TPM 11.25 mg/69 mg) oral capsule, once daily; Weeks 15-56: VI-0521 (PHEN/TPM 15 mg/92 mg) oral capsule, once daily; Weeks 1-56: Lifestyle Modification
|
|---|---|---|---|
|
Psychiatric disorders
Depression
|
0.00%
0/56 • About 1 year (from the time when the subject provides written informed consent and extends until 28 calendar days after the last dose of the investigational product is administered).
|
0.00%
0/54 • About 1 year (from the time when the subject provides written informed consent and extends until 28 calendar days after the last dose of the investigational product is administered).
|
0.88%
1/113 • About 1 year (from the time when the subject provides written informed consent and extends until 28 calendar days after the last dose of the investigational product is administered).
|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/56 • About 1 year (from the time when the subject provides written informed consent and extends until 28 calendar days after the last dose of the investigational product is administered).
|
0.00%
0/54 • About 1 year (from the time when the subject provides written informed consent and extends until 28 calendar days after the last dose of the investigational product is administered).
|
0.88%
1/113 • About 1 year (from the time when the subject provides written informed consent and extends until 28 calendar days after the last dose of the investigational product is administered).
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/56 • About 1 year (from the time when the subject provides written informed consent and extends until 28 calendar days after the last dose of the investigational product is administered).
|
0.00%
0/54 • About 1 year (from the time when the subject provides written informed consent and extends until 28 calendar days after the last dose of the investigational product is administered).
|
0.88%
1/113 • About 1 year (from the time when the subject provides written informed consent and extends until 28 calendar days after the last dose of the investigational product is administered).
|
Other adverse events
| Measure |
Placebo
n=56 participants at risk
Weeks 1-56: Placebo (Inactive drug) oral capsule, once daily; Weeks 1-56: Lifestyle Modification
|
VI-0521 Mid Dose
n=54 participants at risk
Weeks 1-2: VI-0521 (PHEN/TPM 3.75 mg/23 mg) oral capsule, once daily; Weeks 3-56: VI-0521 (PHEN/TPM 7.5 mg/46 mg) oral capsule, once daily; Weeks 1-56: Lifestyle Modification
|
VI-0521 Top Dose
n=113 participants at risk
Weeks 1-2: VI-0521 (PHEN/TPM 3.75 mg/23 mg) oral capsule, once daily; Weeks 3-12: VI-0521 (PHEN/TPM 7.5 mg/46 mg) oral capsule, once daily; Weeks 13-14: VI-0521 (PHEN/TPM 11.25 mg/69 mg) oral capsule, once daily; Weeks 15-56: VI-0521 (PHEN/TPM 15 mg/92 mg) oral capsule, once daily; Weeks 1-56: Lifestyle Modification
|
|---|---|---|---|
|
Infections and infestations
COVID-19
|
7.1%
4/56 • About 1 year (from the time when the subject provides written informed consent and extends until 28 calendar days after the last dose of the investigational product is administered).
|
3.7%
2/54 • About 1 year (from the time when the subject provides written informed consent and extends until 28 calendar days after the last dose of the investigational product is administered).
|
3.5%
4/113 • About 1 year (from the time when the subject provides written informed consent and extends until 28 calendar days after the last dose of the investigational product is administered).
|
|
Infections and infestations
Upper respiratory tract infection
|
7.1%
4/56 • About 1 year (from the time when the subject provides written informed consent and extends until 28 calendar days after the last dose of the investigational product is administered).
|
1.9%
1/54 • About 1 year (from the time when the subject provides written informed consent and extends until 28 calendar days after the last dose of the investigational product is administered).
|
3.5%
4/113 • About 1 year (from the time when the subject provides written informed consent and extends until 28 calendar days after the last dose of the investigational product is administered).
|
|
Infections and infestations
Nasopharyngitis
|
5.4%
3/56 • About 1 year (from the time when the subject provides written informed consent and extends until 28 calendar days after the last dose of the investigational product is administered).
|
1.9%
1/54 • About 1 year (from the time when the subject provides written informed consent and extends until 28 calendar days after the last dose of the investigational product is administered).
|
1.8%
2/113 • About 1 year (from the time when the subject provides written informed consent and extends until 28 calendar days after the last dose of the investigational product is administered).
|
|
Nervous system disorders
Headache
|
8.9%
5/56 • About 1 year (from the time when the subject provides written informed consent and extends until 28 calendar days after the last dose of the investigational product is administered).
|
7.4%
4/54 • About 1 year (from the time when the subject provides written informed consent and extends until 28 calendar days after the last dose of the investigational product is administered).
|
4.4%
5/113 • About 1 year (from the time when the subject provides written informed consent and extends until 28 calendar days after the last dose of the investigational product is administered).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.1%
4/56 • About 1 year (from the time when the subject provides written informed consent and extends until 28 calendar days after the last dose of the investigational product is administered).
|
5.6%
3/54 • About 1 year (from the time when the subject provides written informed consent and extends until 28 calendar days after the last dose of the investigational product is administered).
|
2.7%
3/113 • About 1 year (from the time when the subject provides written informed consent and extends until 28 calendar days after the last dose of the investigational product is administered).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60