Trial Outcomes & Findings for A Study of VI-0521 on Ambulatory Blood Pressure (ABPM) in Overweight or Obese Subjects (NCT NCT05215418)
NCT ID: NCT05215418
Last Updated: 2024-07-17
Results Overview
The change between systolic blood pressure measured at Week 8 relative to the baseline measurements from the ABPM data read out. Blood pressure and heart rate were measured every 20 minutes from 6:00 to 22:00 hours, and every 30 minutes from 22:01 to 5:59 hours for 24 consecutive hours, while subjects continue normal routine activities.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
565 participants
Primary outcome timeframe
Baseline to Week 8
Results posted on
2024-07-17
Participant Flow
Participant milestones
| Measure |
VI-0521 Top Dose (Phentermine 15 mg + Topiramate 92 mg)
Week 1: VI-0521 (Phentermine 3.75 mg + Topiramate 23 mg) oral capsule, once daily; Week 2: VI-0521 (Phentermine 7.5 mg + Topiramate 46 mg) oral capsule, once daily; Week 3: VI-0521 (Phentermine 11.25 mg + Topiramate 69 mg) oral capsule, once daily; Weeks 4-8: VI-0521 (Phentermine 15 mg + Topiramate 92 mg) oral capsule, once daily
VI-0521: Phentermine/Topiramate Top Dose 15 mg/92 mg capsule
|
Phentermine 30mg
Weeks 1-8: Phentermine 30mg oral capsule, once daily
Phentermine: Phentermine 30 mg capsule
|
Placebo
Weeks 1-8: Placebo oral capsule, once daily
Placebo: Inactive oral capsule
|
|---|---|---|---|
|
Overall Study
STARTED
|
190
|
191
|
184
|
|
Overall Study
COMPLETED
|
156
|
167
|
164
|
|
Overall Study
NOT COMPLETED
|
34
|
24
|
20
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of VI-0521 on Ambulatory Blood Pressure (ABPM) in Overweight or Obese Subjects
Baseline characteristics by cohort
| Measure |
VI-0521 Top Dose (Phentermine 15 mg + Topiramate 92 mg)
n=190 Participants
Week 1: VI-0521 (Phentermine 3.75 mg + Topiramate 23 mg) oral capsule, once daily; Week 2: VI-0521 (Phentermine 7.5 mg + Topiramate 46 mg) oral capsule, once daily; Week 3: VI-0521 (Phentermine 11.25 mg + Topiramate 69 mg) oral capsule, once daily; Weeks 4-8: VI-0521 (Phentermine 15 mg + Topiramate 92 mg) oral capsule, once daily
VI-0521: Phentermine/Topiramate Top Dose 15 mg/92 mg capsule
|
Phentermine 30mg
n=191 Participants
Weeks 1-8: Phentermine 30mg oral capsule, once daily
Phentermine: Phentermine 30 mg capsule
|
Placebo
n=184 Participants
Weeks 1-8: Placebo oral capsule, once daily
Placebo: Inactive oral capsule
|
Total
n=565 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
53.6 years
STANDARD_DEVIATION 13.34 • n=5 Participants
|
53.3 years
STANDARD_DEVIATION 12.12 • n=7 Participants
|
53.3 years
STANDARD_DEVIATION 11.36 • n=5 Participants
|
53.4 years
STANDARD_DEVIATION 12.29 • n=4 Participants
|
|
Sex: Female, Male
Female
|
136 Participants
n=5 Participants
|
142 Participants
n=7 Participants
|
137 Participants
n=5 Participants
|
415 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
150 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
52 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
149 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
138 Participants
n=5 Participants
|
141 Participants
n=7 Participants
|
137 Participants
n=5 Participants
|
416 Participants
n=4 Participants
|
|
Ethnicity (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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
25 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
81 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
154 Participants
n=5 Participants
|
167 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
461 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
190 participants
n=5 Participants
|
191 participants
n=7 Participants
|
184 participants
n=5 Participants
|
565 participants
n=4 Participants
|
|
Hypertensive status
No Medical Diagnosis of or Treatment for Hypertension
|
64 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
183 Participants
n=4 Participants
|
|
Hypertensive status
Medical Diagnosis of Hypertension Treated with 0 to 2 Antihypertensive Agents
|
116 Participants
n=5 Participants
|
120 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
353 Participants
n=4 Participants
|
|
Hypertensive status
Medical Diagnosis of Hypertension Treated with 3 or More Antihypertensive Agents
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Diabetes Status
Type 2 Diabetes
|
25 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
|
Diabetes Status
Prediabetes
|
27 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
76 Participants
n=4 Participants
|
|
Diabetes Status
Gestational Diabetes
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Diabetes Status
Borderline Diabetes
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Diabetes Status
Not Diabetic
|
137 Participants
n=5 Participants
|
148 Participants
n=7 Participants
|
138 Participants
n=5 Participants
|
423 Participants
n=4 Participants
|
|
Blood Pressure
Systolic Blood Pressure
|
123.9 mmHg
STANDARD_DEVIATION 9.82 • n=5 Participants
|
123.4 mmHg
STANDARD_DEVIATION 10.38 • n=7 Participants
|
124.5 mmHg
STANDARD_DEVIATION 11.23 • n=5 Participants
|
123.9 mmHg
STANDARD_DEVIATION 10.48 • n=4 Participants
|
|
Blood Pressure
Diastolic Blood Pressure
|
77.5 mmHg
STANDARD_DEVIATION 7.63 • n=5 Participants
|
77.0 mmHg
STANDARD_DEVIATION 7.98 • n=7 Participants
|
78.3 mmHg
STANDARD_DEVIATION 7.71 • n=5 Participants
|
77.6 mmHg
STANDARD_DEVIATION 7.78 • n=4 Participants
|
|
Weight
|
98.8 kg
STANDARD_DEVIATION 20.84 • n=5 Participants
|
99.5 kg
STANDARD_DEVIATION 21.58 • n=7 Participants
|
100.4 kg
STANDARD_DEVIATION 21.52 • n=5 Participants
|
99.6 kg
STANDARD_DEVIATION 21.29 • n=4 Participants
|
|
Height
|
165.7 cm
STANDARD_DEVIATION 9.16 • n=5 Participants
|
166.6 cm
STANDARD_DEVIATION 9.51 • n=7 Participants
|
166.1 cm
STANDARD_DEVIATION 10.08 • n=5 Participants
|
166.2 cm
STANDARD_DEVIATION 9.58 • n=4 Participants
|
|
BMI (Body Mass Index)
|
35.7 kg/m2
STANDARD_DEVIATION 6.20 • n=5 Participants
|
35.4 kg/m2
STANDARD_DEVIATION 5.88 • n=7 Participants
|
36.2 kg/m2
STANDARD_DEVIATION 6.17 • n=5 Participants
|
35.8 kg/m2
STANDARD_DEVIATION 6.08 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 8Population: Subjects who completed the study per protocol. Per Protocol Population (PPP) was defined as: 1. Randomized and received at least one dose of study drug; 2. ≥ 80% treatment compliance; 3. Last daily dose of study drug administered on the same date that ABPM was initiated at Week 8/End of Study or early termination (EOS); 4. ≥ 23.5 hours of ABPM data at baseline and at Week 8/EOS or early termination, and ≥ 75% ABPM readings; 5. No major protocol deviation that impacted ABPM readings.
The change between systolic blood pressure measured at Week 8 relative to the baseline measurements from the ABPM data read out. Blood pressure and heart rate were measured every 20 minutes from 6:00 to 22:00 hours, and every 30 minutes from 22:01 to 5:59 hours for 24 consecutive hours, while subjects continue normal routine activities.
Outcome measures
| Measure |
VI-0521 Top Dose (Phentermine 15 mg + Topiramate 92 mg)
n=122 Participants
Week 1: VI-0521 (Phentermine 3.75 mg + Topiramate 23 mg) oral capsule, once daily; Week 2: VI-0521 (Phentermine 7.5 mg + Topiramate 46 mg) oral capsule, once daily; Week 3: VI-0521 (Phentermine 11.25 mg + Topiramate 69 mg) oral capsule, once daily; Weeks 4-8: VI-0521 (Phentermine 15 mg + Topiramate 92 mg) oral capsule, once daily
VI-0521: Phentermine/Topiramate Top Dose 15 mg/92 mg capsule
|
Phentermine 30mg
n=133 Participants
Weeks 1-8: Phentermine 30mg oral capsule, once daily
Phentermine: Phentermine 30 mg capsule
|
Placebo
n=130 Participants
Weeks 1-8: Placebo oral capsule, once daily
Placebo: Inactive oral capsule
|
|---|---|---|---|
|
Change From Baseline to Week 8 in Mean Systolic Blood Pressure as Measured by 24-hr ABPM
|
-3.3 mmHg
Standard Error 1.07
|
1.4 mmHg
Standard Error 1.05
|
-0.1 mmHg
Standard Error 1.04
|
SECONDARY outcome
Timeframe: Baseline to Week 8Population: Subjects who completed the study per protocol. Per Protocol Population (PPP) was defined as: 1. Randomized and received at least one dose of study drug; 2. ≥ 80% treatment compliance; 3. Last daily dose of study drug administered on the same date that ABPM was initiated at Week 8/End of Study or early termination (EOS); 4. ≥ 23.5 hours of ABPM data at baseline and at Week 8/EOS or early termination, and ≥ 75% ABPM readings; 5. No major protocol deviation that impacted ABPM readings.
The change between diastolic blood pressure measured at Week 8 relative to the baseline measurements from the ABPM data read out. Blood pressure and heart rate were measured every 20 minutes from 6:00 to 22:00 hours, and every 30 minutes from 22:01 to 5:59 hours for 24 consecutive hours, while subjects continue normal routine activities.
Outcome measures
| Measure |
VI-0521 Top Dose (Phentermine 15 mg + Topiramate 92 mg)
n=122 Participants
Week 1: VI-0521 (Phentermine 3.75 mg + Topiramate 23 mg) oral capsule, once daily; Week 2: VI-0521 (Phentermine 7.5 mg + Topiramate 46 mg) oral capsule, once daily; Week 3: VI-0521 (Phentermine 11.25 mg + Topiramate 69 mg) oral capsule, once daily; Weeks 4-8: VI-0521 (Phentermine 15 mg + Topiramate 92 mg) oral capsule, once daily
VI-0521: Phentermine/Topiramate Top Dose 15 mg/92 mg capsule
|
Phentermine 30mg
n=133 Participants
Weeks 1-8: Phentermine 30mg oral capsule, once daily
Phentermine: Phentermine 30 mg capsule
|
Placebo
n=130 Participants
Weeks 1-8: Placebo oral capsule, once daily
Placebo: Inactive oral capsule
|
|---|---|---|---|
|
Change From Baseline to Week 8 in Mean Diastolic Blood Pressure as Measured by 24-hr ABPM
|
0.8 mmHg
Standard Error 0.64
|
2.4 mmHg
Standard Error 0.64
|
-0.4 mmHg
Standard Error 0.63
|
SECONDARY outcome
Timeframe: Baseline to Week 8Population: Subjects who completed the study per protocol. Per Protocol Population (PPP) was defined as: 1. Randomized and received at least one dose of study drug; 2. ≥ 80% treatment compliance; 3. Last daily dose of study drug administered on the same date that ABPM was initiated at Week 8/End of Study or early termination (EOS); 4. ≥ 23.5 hours of ABPM data at baseline and at Week 8/EOS or early termination, and ≥ 75% ABPM readings; 5. No major protocol deviation that impacted ABPM readings.
The change between systolic and diastolic blood pressure measured in the clinic at Week 8 relative to the baseline measurements after subjects are seated comfortably for at least 10 minutes prior to taking blood pressure. In clinic blood pressure for determining hypertension was the average of three successive blood pressure readings, collected at least 2 minutes apart. The mean of the three values was be recorded as the subject's blood pressure.
Outcome measures
| Measure |
VI-0521 Top Dose (Phentermine 15 mg + Topiramate 92 mg)
n=122 Participants
Week 1: VI-0521 (Phentermine 3.75 mg + Topiramate 23 mg) oral capsule, once daily; Week 2: VI-0521 (Phentermine 7.5 mg + Topiramate 46 mg) oral capsule, once daily; Week 3: VI-0521 (Phentermine 11.25 mg + Topiramate 69 mg) oral capsule, once daily; Weeks 4-8: VI-0521 (Phentermine 15 mg + Topiramate 92 mg) oral capsule, once daily
VI-0521: Phentermine/Topiramate Top Dose 15 mg/92 mg capsule
|
Phentermine 30mg
n=133 Participants
Weeks 1-8: Phentermine 30mg oral capsule, once daily
Phentermine: Phentermine 30 mg capsule
|
Placebo
n=130 Participants
Weeks 1-8: Placebo oral capsule, once daily
Placebo: Inactive oral capsule
|
|---|---|---|---|
|
Mean Change in Systolic and Diastolic Blood Pressure From Baseline to Week 8 as Measured in Clinic
Systolic blood pressure as measured in clinic
|
-4.3 mmHg
Standard Error 1.15
|
-1.2 mmHg
Standard Error 1.13
|
-1.7 mmHg
Standard Error 1.12
|
|
Mean Change in Systolic and Diastolic Blood Pressure From Baseline to Week 8 as Measured in Clinic
Diastolic blood pressure as measured in clinic
|
-1.3 mmHg
Standard Error 0.82
|
1.0 mmHg
Standard Error 0.81
|
-1.1 mmHg
Standard Error 0.80
|
Adverse Events
VI-0521 Top Dose (Phentermine 15 mg + Topiramate 92 mg)
Serious events: 0 serious events
Other events: 66 other events
Deaths: 0 deaths
Phentermine 30mg
Serious events: 1 serious events
Other events: 44 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 Top Dose (Phentermine 15 mg + Topiramate 92 mg)
n=190 participants at risk
Week 1: VI-0521 (Phentermine 3.75 mg + Topiramate 23 mg) oral capsule, once daily; Week 2: VI-0521 (Phentermine 7.5 mg + Topiramate 46 mg) oral capsule, once daily; Week 3: VI-0521 (Phentermine 11.25 mg + Topiramate 69 mg) oral capsule, once daily; Weeks 4-8: VI-0521 (Phentermine 15 mg + Topiramate 92 mg) oral capsule, once daily
VI-0521: Phentermine/Topiramate Top Dose 15 mg/92 mg capsule
|
Phentermine 30mg
n=191 participants at risk
Weeks 1-8: Phentermine 30mg oral capsule, once daily
Phentermine: Phentermine 30 mg capsule
|
Placebo
n=184 participants at risk
Weeks 1-8: Placebo oral capsule, once daily
Placebo: Inactive oral capsule
|
|---|---|---|---|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/190 • Up to a total of 12 weeks (from baseline to 28 days after last dose of study drug)
|
0.52%
1/191 • Up to a total of 12 weeks (from baseline to 28 days after last dose of study drug)
|
0.00%
0/184 • Up to a total of 12 weeks (from baseline to 28 days after last dose of study drug)
|
Other adverse events
| Measure |
VI-0521 Top Dose (Phentermine 15 mg + Topiramate 92 mg)
n=190 participants at risk
Week 1: VI-0521 (Phentermine 3.75 mg + Topiramate 23 mg) oral capsule, once daily; Week 2: VI-0521 (Phentermine 7.5 mg + Topiramate 46 mg) oral capsule, once daily; Week 3: VI-0521 (Phentermine 11.25 mg + Topiramate 69 mg) oral capsule, once daily; Weeks 4-8: VI-0521 (Phentermine 15 mg + Topiramate 92 mg) oral capsule, once daily
VI-0521: Phentermine/Topiramate Top Dose 15 mg/92 mg capsule
|
Phentermine 30mg
n=191 participants at risk
Weeks 1-8: Phentermine 30mg oral capsule, once daily
Phentermine: Phentermine 30 mg capsule
|
Placebo
n=184 participants at risk
Weeks 1-8: Placebo oral capsule, once daily
Placebo: Inactive oral capsule
|
|---|---|---|---|
|
Gastrointestinal disorders
Dry mouth
|
11.6%
22/190 • Number of events 22 • Up to a total of 12 weeks (from baseline to 28 days after last dose of study drug)
|
11.5%
22/191 • Number of events 22 • Up to a total of 12 weeks (from baseline to 28 days after last dose of study drug)
|
0.54%
1/184 • Number of events 1 • Up to a total of 12 weeks (from baseline to 28 days after last dose of study drug)
|
|
Gastrointestinal disorders
Constipation
|
3.7%
7/190 • Number of events 8 • Up to a total of 12 weeks (from baseline to 28 days after last dose of study drug)
|
5.8%
11/191 • Number of events 11 • Up to a total of 12 weeks (from baseline to 28 days after last dose of study drug)
|
1.1%
2/184 • Number of events 2 • Up to a total of 12 weeks (from baseline to 28 days after last dose of study drug)
|
|
Nervous system disorders
Dizziness
|
5.8%
11/190 • Number of events 13 • Up to a total of 12 weeks (from baseline to 28 days after last dose of study drug)
|
4.7%
9/191 • Number of events 10 • Up to a total of 12 weeks (from baseline to 28 days after last dose of study drug)
|
0.54%
1/184 • Number of events 1 • Up to a total of 12 weeks (from baseline to 28 days after last dose of study drug)
|
|
Nervous system disorders
Paraesthesia
|
9.5%
18/190 • Number of events 27 • Up to a total of 12 weeks (from baseline to 28 days after last dose of study drug)
|
0.52%
1/191 • Number of events 1 • Up to a total of 12 weeks (from baseline to 28 days after last dose of study drug)
|
0.54%
1/184 • Number of events 1 • Up to a total of 12 weeks (from baseline to 28 days after last dose of study drug)
|
|
Psychiatric disorders
Insomnia
|
4.2%
8/190 • Number of events 9 • Up to a total of 12 weeks (from baseline to 28 days after last dose of study drug)
|
5.2%
10/191 • Number of events 10 • Up to a total of 12 weeks (from baseline to 28 days after last dose of study drug)
|
0.54%
1/184 • Number of events 1 • Up to a total of 12 weeks (from baseline to 28 days after last dose of study drug)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place