Back to resultsA Phase IV Safety and Efficacy Study of VI-0521 in Adolescents With Obesity
Primary Purpose
Adolescent Obesity, Obesity in Adolescence, Adolescent Overweight
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
VI-0521 oral capsule
Placebo oral capsule
Lifestyle Modification
Sponsored by
About this trial
This is an interventional treatment trial for Adolescent Obesity focused on measuring weight loss, obesity, weight control
Eligibility Criteria
Inclusion Criteria:
- Aged ≥ 12 years and < 17 years;
- BMI ≥ the 95th percentile, with documented history of failure to lose sufficient weight or failure to maintain weight loss in a lifestyle modification program;
- If female, must be using adequate contraception, defined as double barrier methods, stable hormonal contraception plus single barrier method, tubal ligation, or abstinence.
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:
- Anticonvulsants used for treatment of seizure disorder, including barbiturates, benzodiazepines, gamma-aminobutyric acid (GABA) analogues, hydantoins, phenyltriazines, succinimides, and other agents (valproic acid and its derivatives, carbamazepine and its derivatives, zonisamide, and felbamate);
- Tricyclic antidepressants, monoamine oxidase inhibitors (MAOIs), lithium, levodopa, and dopamine receptor agonists;
- Carbonic anhydrase inhibitors;
- Insulin, Sulfonylureas (SFUs), glucagon-like peptide -1 (GLP-1) agonists, sodium glucose transporter-1 (SGLT-1), and SGLT-2 inhibitors;
- Chronic systemic steroids (i.e. glucocorticoids, anabolic steroids) other than oral contraceptives;
- Treatment for hyperactivity disorder; or
- Over the counter, prescription medications, herbal agents and dietary supplements used with the intention to lose body weight.
Sites / Locations
- Intend Research, LLC
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
VI-0521 Mid Dose (Phentermine 7.5 mg +Topiramate 46 mg)
VI-0521 Top Dose (Phentermine 15 mg + Topiramate 92 mg)
Placebo
Arm Description
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
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
Subjects will receive placebo oral capsule, once daily for up to 56 weeks
Outcomes
Primary Outcome Measures
Mean % Change in Body Mass Index (BMI)
Mean % change in BMI from Baseline to Week 56
Secondary Outcome Measures
Percentage of Subjects Achieving at Least 5% BMI Reduction at Week 56
Percentage of Subjects Achieving at Least 10% BMI Reduction at Week 56
Percentage of Subjects Achieving at Least 15% BMI Reduction at Week 56
Change in Waist Circumference at Week 56
Change in waist circumference from Baseline to 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.
Change in Fasting Insulin at Week 56
Change in fasting insulin from Baseline to Week 56
Percent Change in Triglycerides From Baseline to Week 56
Percent Change in HDL-C From Baseline to Week 56
Change From Baseline in Systolic Blood Pressure at Week 56
Change From Baseline in Diastolic Blood Pressure at Week 56
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03922945
Brief Title
A Phase IV Safety and Efficacy Study of VI-0521 in Adolescents With Obesity
Official Title
A Phase IV, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design Study to Determine the Safety and Efficacy of VI-0521 in Obese Adolescents
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
May 2, 2019 (Actual)
Primary Completion Date
April 16, 2021 (Actual)
Study Completion Date
April 16, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VIVUS LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Obesity, Obesity in Adolescence, Adolescent Overweight
Keywords
weight loss, obesity, weight control
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
223 (Actual)
8. Arms, Groups, and Interventions
Arm Title
VI-0521 Mid Dose (Phentermine 7.5 mg +Topiramate 46 mg)
Arm Type
Experimental
Arm Description
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
Arm Title
VI-0521 Top Dose (Phentermine 15 mg + Topiramate 92 mg)
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will receive placebo oral capsule, once daily for up to 56 weeks
Intervention Type
Drug
Intervention Name(s)
VI-0521 oral capsule
Other Intervention Name(s)
Qsymia, Phentermine and topiramate
Intervention Description
Phentermine/Topiramate
Intervention Type
Drug
Intervention Name(s)
Placebo oral capsule
Intervention Description
Inactive drug
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle Modification
Intervention Description
The lifestyle modification includes physical activity, behavior change, reduced calorie diet advice, and family support. This intervention is applied to all treatment groups.
Primary Outcome Measure Information:
Title
Mean % Change in Body Mass Index (BMI)
Description
Mean % change in BMI from Baseline to Week 56
Time Frame
Baseline to Week 56
Secondary Outcome Measure Information:
Title
Percentage of Subjects Achieving at Least 5% BMI Reduction at Week 56
Time Frame
Baseline to Week 56
Title
Percentage of Subjects Achieving at Least 10% BMI Reduction at Week 56
Time Frame
Baseline to Week 56
Title
Percentage of Subjects Achieving at Least 15% BMI Reduction at Week 56
Time Frame
Baseline to Week 56
Title
Change in Waist Circumference at Week 56
Description
Change in waist circumference from Baseline to Week 56
Time Frame
Baseline, Week 56
Title
Change in Whole Body Insulin Sensitivity Index (WBISI) (Matsuda) at Week 56
Description
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.
Time Frame
Baseline, Week 56
Title
Change in Fasting Insulin at Week 56
Description
Change in fasting insulin from Baseline to Week 56
Time Frame
Baseline, Week 56
Title
Percent Change in Triglycerides From Baseline to Week 56
Time Frame
Baseline, Week 56
Title
Percent Change in HDL-C From Baseline to Week 56
Time Frame
Baseline, Week 56
Title
Change From Baseline in Systolic Blood Pressure at Week 56
Time Frame
Baseline, Week 56
Title
Change From Baseline in Diastolic Blood Pressure at Week 56
Time Frame
Baseline, Week 56
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged ≥ 12 years and < 17 years;
BMI ≥ the 95th percentile, with documented history of failure to lose sufficient weight or failure to maintain weight loss in a lifestyle modification program;
If female, must be using adequate contraception, defined as double barrier methods, stable hormonal contraception plus single barrier method, tubal ligation, or abstinence.
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:
Anticonvulsants used for treatment of seizure disorder, including barbiturates, benzodiazepines, gamma-aminobutyric acid (GABA) analogues, hydantoins, phenyltriazines, succinimides, and other agents (valproic acid and its derivatives, carbamazepine and its derivatives, zonisamide, and felbamate);
Tricyclic antidepressants, monoamine oxidase inhibitors (MAOIs), lithium, levodopa, and dopamine receptor agonists;
Carbonic anhydrase inhibitors;
Insulin, Sulfonylureas (SFUs), glucagon-like peptide -1 (GLP-1) agonists, sodium glucose transporter-1 (SGLT-1), and SGLT-2 inhibitors;
Chronic systemic steroids (i.e. glucocorticoids, anabolic steroids) other than oral contraceptives;
Treatment for hyperactivity disorder; or
Over the counter, prescription medications, herbal agents and dietary supplements used with the intention to lose body weight.
Facility Information:
Facility Name
Intend Research, LLC
City
Norman
State/Province
Oklahoma
ZIP/Postal Code
73069
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Phase IV Safety and Efficacy Study of VI-0521 in Adolescents With Obesity
We'll reach out to this number within 24 hrs