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This study is being conducted to assess weight loss efficacy, as determined by changes in body mass index (BMI), and safety of VI-0521 (Qsymia®) or placebo, taken for 56 weeks accompanied by a lifestyle modification program in obese adolescents age 12-16 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VI-0521 Mid Dose (Phentermine 7.5 mg +Topiramate 46 mg) | Experimental | Weeks 1-2: VI-0521 (Phentermine 3.75 mg + Topiramate 23 mg) oral capsule, once daily; Weeks 3-56: VI-0521 (Phentermine 7.5 mg + Topiramate 46 mg) oral capsule, once daily |
|
| VI-0521 Top Dose (Phentermine 15 mg + Topiramate 92 mg) | Experimental | Weeks 1-2: VI-0521 (Phentermine 3.75 mg + Topiramate 23 mg) oral capsule, once daily; Weeks 3-12: VI-0521 (Phentermine 7.5 mg + Topiramate 46 mg) oral capsule, once daily; Weeks 13-14: VI-0521 (Phentermine 11.25 mg + Topiramate 69 mg) oral capsule, once daily; Weeks 15-56: VI-0521 (Phentermine 15 mg + Topiramate 92 mg) oral capsule, once daily |
|
| Placebo | Placebo Comparator | Subjects will receive placebo oral capsule, once daily for up to 56 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VI-0521 oral capsule | Drug | Phentermine/Topiramate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean % Change in Body Mass Index (BMI) | Mean % change in BMI from Baseline to Week 56 | Baseline to Week 56 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Achieving at Least 5% BMI Reduction at Week 56 | Baseline to Week 56 | |
| Percentage of Subjects Achieving at Least 10% BMI Reduction at Week 56 | Baseline to Week 56 | |
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Inclusion Criteria:
Exclusion Criteria:
Type 1 diabetes;
Congenital heart disease; clinically significant ECG abnormality;
Clinically significant physical exam, vital signs, or laboratory abnormality; clinically significant hepatic or renal disease;
Estimated Glomerular Filtration Rate (GFR; Schwartz formula) < 60 mL/minute;
Clinically significant thyroid dysfunction as evidenced by signs, symptoms, or thyroid stimulating hormone (TSH) > 1.5 x Upper Limit of Normal;
Obesity of known genetic or endocrine origin;
History of bipolar disorder or psychosis, depression of moderate or greater severity, or presence or history of suicidal behavior or active suicidal ideation;
Recent weight instability, or prior bariatric surgery;
History of glaucoma or increased intraocular pressure;
Current smoker or smoking cessation within 3 months of screening;
Currently taking or plan on taking any of following medications during the study:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intend Research, LLC | Norman | Oklahoma | 73069 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40518455 | Derived | Bensignor MO, Freese RL, Rudser KD, Kelly AS, Kunin-Batson A, Gross AC, Bramante C, Shih W, Peterson C, Fox CK. Predictors of BMI reduction with phentermine/topiramate in adolescents with obesity. Int J Obes (Lond). 2025 Sep;49(9):1777-1780. doi: 10.1038/s41366-025-01821-6. Epub 2025 Jun 15. | |
| 36968652 | Derived |
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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.
The study was conducted at 26 study sites in the United States.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Weeks 1-56: Placebo (Inactive drug) oral capsule, once daily; Weeks 1-56: Lifestyle Modification |
| FG001 | 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 |
| FG002 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Weeks 1-56: Placebo (Inactive drug) oral capsule, once daily; Weeks 1-56: Lifestyle Modification |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean % Change in Body Mass Index (BMI) | Mean % change in BMI from Baseline to Week 56 | Posted | Least Squares Mean | Standard Error | Percentage Change | Baseline to Week 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).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Weeks 1-56: Placebo (Inactive drug) oral capsule, once daily; Weeks 1-56: Lifestyle Modification |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Depression | Psychiatric disorders | MedDRA (23.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Director, Clinical Research | VIVUS | 650-934-5200 | clinical@vivus.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 21, 2019 | Jul 18, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 1, 2021 | Jul 18, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| D015431 | Weight Loss |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C576188 | Qsymia |
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|
| Placebo oral capsule | Drug | Inactive drug |
|
| Lifestyle Modification | Behavioral | The lifestyle modification includes physical activity, behavior change, reduced calorie diet advice, and family support. This intervention is applied to all treatment groups. |
|
| Percentage of Subjects Achieving at Least 15% BMI Reduction at Week 56 |
| Baseline to Week 56 |
| Change in Waist Circumference at Week 56 | Change in waist circumference from Baseline to Week 56 | Baseline, Week 56 |
| Change in Whole Body Insulin Sensitivity Index (WBISI) (Matsuda) at 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. | Baseline, Week 56 |
| Change in Fasting Insulin at Week 56 | Change in fasting insulin from Baseline to Week 56 | Baseline, Week 56 |
| Percent Change in Triglycerides From Baseline to Week 56 | Baseline, Week 56 |
| Percent Change in HDL-C From Baseline to Week 56 | Baseline, Week 56 |
| Change From Baseline in Systolic Blood Pressure at Week 56 | Baseline, Week 56 |
| Change From Baseline in Diastolic Blood Pressure at Week 56 | Baseline, Week 56 |
| Kelly AS, Bensignor MO, Hsia DS, Shoemaker AH, Shih W, Peterson C, Varghese ST. Phentermine/Topiramate for the Treatment of Adolescent Obesity. NEJM Evid. 2022 Jun;1(6):10.1056/evidoa2200014. doi: 10.1056/evidoa2200014. Epub 2022 Apr 30. |
| Lack of Efficacy |
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| Protocol Non-Compliance |
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| Withdrawal by Subject / Parent / Legal Guardian |
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| All Other Personal Reasons |
|
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| BMI Categories | Count of Participants | 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 |
|
|
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| Secondary | Percentage of Subjects Achieving at Least 5% BMI Reduction at Week 56 | Posted | Number | percentage of participants | Baseline to Week 56 |
|
|
|
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| Secondary | Percentage of Subjects Achieving at Least 10% BMI Reduction at Week 56 | Posted | Number | percentage of participants | Baseline to Week 56 |
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| Secondary | Percentage of Subjects Achieving at Least 15% BMI Reduction at Week 56 | Posted | Number | percentage of participants | Baseline to Week 56 |
|
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| Secondary | Change in Waist Circumference at Week 56 | Change in waist circumference from Baseline to Week 56 | Posted | Least Squares Mean | Standard Error | Centimeter | Baseline, Week 56 |
|
|
|
| Secondary | Change in Whole Body Insulin Sensitivity Index (WBISI) (Matsuda) at 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. | The number of subjects with values at both time points (Baseline and Week 56) | Posted | Least Squares Mean | Standard Error | Index | Baseline, Week 56 |
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| Secondary | Change in Fasting Insulin at Week 56 | Change in fasting insulin from Baseline to Week 56 | Posted | Least Squares Mean | Standard Error | uIU/mL | Baseline, Week 56 |
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| Secondary | Percent Change in Triglycerides From Baseline to Week 56 | Posted | Least Squares Mean | Standard Error | Percent Change | Baseline, Week 56 |
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| Secondary | Percent Change in HDL-C From Baseline to Week 56 | Posted | Least Squares Mean | Standard Error | Percent Change | Baseline, Week 56 |
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| Secondary | Change From Baseline in Systolic Blood Pressure at Week 56 | Posted | Least Squares Mean | Standard Error | mmHg | Baseline, Week 56 |
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| Secondary | Change From Baseline in Diastolic Blood Pressure at Week 56 | Posted | Least Squares Mean | Standard Error | mmHg | Baseline, Week 56 |
|
|
|
| 0 |
| 56 |
| 0 |
| 56 |
| 20 |
| 56 |
| EG001 | 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 | 0 | 54 | 0 | 54 | 11 | 54 |
| EG002 | 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 | 0 | 113 | 2 | 113 | 18 | 113 |
| Suicidal Ideation | Psychiatric disorders | MedDRA (23.1) | Systematic Assessment |
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| Bile duct stone | Hepatobiliary disorders | MedDRA (23.1) | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (23.1) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (23.1) | Systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (23.1) | Systematic Assessment |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |