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A Phase IV Safety and Efficacy Study of VI-0521 in Adolescents With Obesity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03922945
Recruitment Status : Completed
First Posted : April 22, 2019
Results First Posted : September 10, 2022
Last Update Posted : September 10, 2022
Sponsor:
Information provided by (Responsible Party):
VIVUS LLC

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.

Condition or disease Intervention/treatment Phase
Adolescent Obesity Obesity in Adolescence Adolescent Overweight Drug: VI-0521 oral capsule Drug: Placebo oral capsule Behavioral: Lifestyle Modification Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 223 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : May 2, 2019
Actual Primary Completion Date : April 16, 2021
Actual Study Completion Date : April 16, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: VI-0521 Mid Dose (Phentermine 7.5 mg +Topiramate 46 mg)
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
Drug: VI-0521 oral capsule
Phentermine/Topiramate
Other Names:
  • Qsymia
  • Phentermine and topiramate

Behavioral: Lifestyle Modification
The lifestyle modification includes physical activity, behavior change, reduced calorie diet advice, and family support. This intervention is applied to all treatment groups.

Experimental: VI-0521 Top Dose (Phentermine 15 mg + Topiramate 92 mg)
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
Drug: VI-0521 oral capsule
Phentermine/Topiramate
Other Names:
  • Qsymia
  • Phentermine and topiramate

Behavioral: Lifestyle Modification
The lifestyle modification includes physical activity, behavior change, reduced calorie diet advice, and family support. This intervention is applied to all treatment groups.

Placebo Comparator: Placebo
Subjects will receive placebo oral capsule, once daily for up to 56 weeks
Drug: Placebo oral capsule
Inactive drug

Behavioral: Lifestyle Modification
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 Measures :
  1. Mean % Change in Body Mass Index (BMI) [ Time Frame: Baseline to Week 56 ]
    Mean % change in BMI from Baseline to Week 56


Secondary Outcome Measures :
  1. Percentage of Subjects Achieving at Least 5% BMI Reduction at Week 56 [ Time Frame: Baseline to Week 56 ]
  2. Percentage of Subjects Achieving at Least 10% BMI Reduction at Week 56 [ Time Frame: Baseline to Week 56 ]
  3. Percentage of Subjects Achieving at Least 15% BMI Reduction at Week 56 [ Time Frame: Baseline to Week 56 ]
  4. Change in Waist Circumference at Week 56 [ Time Frame: Baseline, Week 56 ]
    Change in waist circumference from Baseline to Week 56

  5. Change in Whole Body Insulin Sensitivity Index (WBISI) (Matsuda) at Week 56 [ Time Frame: Baseline, 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.

  6. Change in Fasting Insulin at Week 56 [ Time Frame: Baseline, Week 56 ]
    Change in fasting insulin from Baseline to Week 56

  7. Percent Change in Triglycerides From Baseline to Week 56 [ Time Frame: Baseline, Week 56 ]
  8. Percent Change in HDL-C From Baseline to Week 56 [ Time Frame: Baseline, Week 56 ]
  9. Change From Baseline in Systolic Blood Pressure at Week 56 [ Time Frame: Baseline, Week 56 ]
  10. Change From Baseline in Diastolic Blood Pressure at Week 56 [ Time Frame: Baseline, Week 56 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03922945


Locations
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United States, Oklahoma
Intend Research, LLC
Norman, Oklahoma, United States, 73069
Sponsors and Collaborators
VIVUS LLC
  Study Documents (Full-Text)

Documents provided by VIVUS LLC:
Study Protocol  [PDF] June 21, 2019
Statistical Analysis Plan  [PDF] April 1, 2021

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Responsible Party: VIVUS LLC
ClinicalTrials.gov Identifier: NCT03922945    
Other Study ID Numbers: OB-403
First Posted: April 22, 2019    Key Record Dates
Results First Posted: September 10, 2022
Last Update Posted: September 10, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by VIVUS LLC:
weight loss
obesity
weight control
Additional relevant MeSH terms:
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Obesity
Pediatric Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Topiramate
Phentermine
Anticonvulsants
Hypoglycemic Agents
Physiological Effects of Drugs
Central Nervous System Stimulants
Appetite Depressants
Anti-Obesity Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action