Obesity
Conditions
Keywords
Obesity
Brief summary
The purpose of this study is to evaluate the long-term safety and efficacy of VI-0521 compared to placebo for the treatment of overweight and obesity in adults who have completed study OB-303 (NCT00553787) at selected study sites. This is an extension study of protocol OB-303 (NCT00553787).
Interventions
DRUGVI-0521
7.5 mg phentermine and 46 mg topiramate
DRUGPlacebo
placebo
Sponsors
Medpace, Inc.
VIVUS LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
To be eligible for enrollment into this study, subjects must meet all of the following criteria: * Completion of study OB-303 (NCT00553787) on treatment and compliance with all protocol requirements * Written informed consent * Female subjects of childbearing potential must be using adequate contraception, defined as double-barrier methods, stable hormonal contraception plus single barrier method, or tubal ligation. Female subjects are considered to be of childbearing potential unless they have undergone a hysterectomy or bilateral oophorectomy, are ≥55 years of age and experienced spontaneous cessation of menses for at least 1 year, or have a documented follicle-stimulating hormone level ≥40 IU/L * Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Exclusion criteria
Subjects will not be included in the study if they meet any of the following: * Body mass index ≤22 kg/m2 at the completion of study OB-303 * Off study medication at completion of study OB-303 (NCT00553787) for longer than 4 weeks continuously due to an event-driven holiday, or off study medication with no plans to restart * Development of any condition during study OB-303 (NCT00553787) that, in the opinion of the investigator, would contraindicate the administration of study medication, affect compliance, interfere with study evaluations, or confound the interpretation of study results * Participation in a formal weight loss program (including: Weight Watchers and related dietary/lifestyle intervention programs; prepared food programs; prescribed or over the counter weight loss medications; dietary supplement or herbal preparations, teas, or tinctures intended for weight loss; or any supervised fast or very low calorie diet).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Weight Change at End of Treatment, Week 108. | From baseline to end of treatment |
| Percentage of Subjects With at Least 5% Weight Loss at End of Treatment, Week 108. | Baseline to End of Treatment |
Participant flow
Recruitment details
Subjects were from OB-303 (NCT00553787)
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo | 227 |
| VI-0521 Mid VI-0521 7.5 mg PHEN/46 mg TPM | 153 |
| VI-0521 Top VI-0521 15 mg PHEN/92 mg TPM | 295 |
| Total | 675 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 6 | 4 | 7 |
| Overall Study | Lack of Efficacy | 2 | 1 | 0 |
| Overall Study | Lost to Follow-up | 5 | 4 | 21 |
| Overall Study | non compliance | 3 | 1 | 1 |
| Overall Study | other | 2 | 4 | 3 |
| Overall Study | Pregnancy | 1 | 0 | 1 |
| Overall Study | Requirement for restricted medication | 2 | 0 | 2 |
| Overall Study | Withdrawal by Subject | 9 | 11 | 12 |
Baseline characteristics
| Characteristic | Placebo | VI-0521 Mid | VI-0521 Top | Total |
|---|---|---|---|---|
| Age Continuous | 52.7 years STANDARD_DEVIATION 9.8 | 52.2 years STANDARD_DEVIATION 10.6 | 51.2 years STANDARD_DEVIATION 10.4 | 51.9 years STANDARD_DEVIATION 10.2 |
| Region of Enrollment United States | 227 participants | 153 participants | 295 participants | 675 participants |
| Sex: Female, Male Female | 147 Participants | 106 Participants | 195 Participants | 448 Participants |
| Sex: Female, Male Male | 80 Participants | 47 Participants | 100 Participants | 227 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 182 / 227 | 111 / 153 | 234 / 295 |
| serious Total, serious adverse events | 9 / 227 | 4 / 153 | 13 / 295 |
Outcome results
Primary
Percentage of Subjects With at Least 5% Weight Loss at End of Treatment, Week 108.
Time frame: Baseline to End of Treatment
Population: Intent-to-treat Last-observation-carried-forward (ITT-LOCF)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Subjects With at Least 5% Weight Loss at End of Treatment, Week 108. | 30 percent participants |
| VI-0521 Mid | Percentage of Subjects With at Least 5% Weight Loss at End of Treatment, Week 108. | 75.2 percent participants |
| VI-0521 Top | Percentage of Subjects With at Least 5% Weight Loss at End of Treatment, Week 108. | 79.3 percent participants |
Comparison: No formal calculation of sample size was conducted due to being an extension study of OB-303 (NCT00553787)p-value: <0.000195% CI: [6.24, 14.16]Regression, Logistic
Comparison: No formal calculation of sample size was conducted due to being an extension study of OB-303 (NCT00553787)p-value: <0.000195% CI: [4.36, 11.19]Regression, Logistic
Comparison: No formal calculation of sample size was conducted due to being an extension study of OB-303 (NCT00553787)p-value: 0.216995% CI: [0.84, 2.15]Regression, Logistic
Primary
Percent Weight Change at End of Treatment, Week 108.
Time frame: From baseline to end of treatment
Population: Intent-to-Treat Last observation carried forward (ITT-LOCF)
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Percent Weight Change at End of Treatment, Week 108. | -1.8 percent weight loss | Standard Error 0.55 |
| VI-0521 Mid | Percent Weight Change at End of Treatment, Week 108. | -9.32 percent weight loss | Standard Error 0.67 |
| VI-0521 Top | Percent Weight Change at End of Treatment, Week 108. | -10.5 percent weight loss | Standard Error 0.5 |
Comparison: No formal calculation of sample size was conducted due to being an extension study of OB-303 (NCT00553787)p-value: <0.000195% CI: [7.39, 10.03]ANCOVA
Comparison: No formal calculation of sample size was conducted due to being an extension study of OB-303 (NCT00553787)p-value: <0.000195% CI: [5.95, 9.09]ANCOVA
Comparison: No formal calculation of sample size was conducted due to being an extension study of OB-303 (NCT00553787)p-value: 0.118995% CI: [-0.31, 2.68]ANCOVA