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A Phase IV Safety and Efficacy of VI-0521 in Obese Adolescents

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ClinicalTrials.gov Identifier: NCT03922945
Recruitment Status : Recruiting
First Posted : April 22, 2019
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
VIVUS, Inc.

Tracking Information
First Submitted Date  ICMJE April 16, 2019
First Posted Date  ICMJE April 22, 2019
Last Update Posted Date September 13, 2019
Actual Study Start Date  ICMJE May 2, 2019
Estimated Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2019)
Mean % change in body mass index (BMI) [ Time Frame: Baseline to Week 56 ]
Mean % change in BMI from Baseline to Week 56
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03922945 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2019)
  • Percentage of subjects achieving at least 5% BMI reduction at Week 56 [ Time Frame: Baseline to Week 56 ]
  • Percentage of subjects achieving at least 10% BMI reduction at Week 56 [ Time Frame: Baseline to Week 56 ]
  • Percentage of subjects achieving at least 15% BMI reduction at Week 56 [ Time Frame: Baseline to Week 56 ]
  • Change in waist circumference at Week 56 [ Time Frame: Baseline to Week 56 ]
  • Change in Whole Body Insulin Sensitivity Index at Week 56 [ Time Frame: Baseline to Week 56 ]
  • Change in fasting insulin at Week 56 [ Time Frame: Baseline to Week 56 ]
  • Change in triglycerides at Week 56 [ Time Frame: Baseline to Week 56 ]
  • Change in HDL-C (High-Density Lipoprotein Cholesterol) at Week 56 [ Time Frame: Baseline to Week 56 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase IV Safety and Efficacy of VI-0521 in Obese Adolescents
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Adolescent Obesity
  • Obesity in Adolescence
  • Adolescent Overweight
Intervention  ICMJE
  • Drug: VI-0521 oral capsule
    Phentermine/Topiramate
    Other Names:
    • Qsymia
    • Phentermine and topiramate
  • Drug: Placebo oral capsule
    Inactive drug
Study Arms  ICMJE
  • 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
    Intervention: Drug: VI-0521 oral capsule
  • 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
    Intervention: Drug: VI-0521 oral capsule
  • Placebo Comparator: Placebo
    Subjects will receive placebo oral capsule, once daily for up to 56 weeks
    Intervention: Drug: Placebo oral capsule
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 18, 2019)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2020
Estimated Primary Completion Date September 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 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, GABA analogues, hydantoins, phenyltriazines, succinimides, and other agents (valproic acid and its derivatives, carbamazepine and its derivatives, zonisamide, and felbamate);
    • Tricyclic antidepressants, MAOIs, lithium, levodopa, and dopamine receptor agonists;
    • Carbonic anhydrase inhibitors;
    • Insulin, SFUs, GLP-1 agonists, 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 16 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Winnie Shih 650-934-5200 Shih@vivus.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03922945
Other Study ID Numbers  ICMJE OB-403
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party VIVUS, Inc.
Study Sponsor  ICMJE VIVUS, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account VIVUS, Inc.
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP