A Pharmacokinetic Study Comparing VI-0521 With Placebo in Obese Adolescents
A Randomized, Double-Blind, Placebo-Controlled, Pharmacokinetic and Pharmacodynamic Study of VI-0521 in Obese Adolescents
1 other identifier
interventional
42
1 country
4
Brief Summary
The primary objective of this study is to describe the pharmacokinetic profiles of VI-0521 in obese adolescents.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Mar 2016
Shorter than P25 for phase_4
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 8, 2016
CompletedFirst Posted
Study publicly available on registry
March 21, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedResults Posted
Study results publicly available
February 5, 2018
CompletedAugust 23, 2022
August 1, 2022
7 months
March 8, 2016
October 24, 2017
August 19, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Apparent Clearance (CL/F) of Phentermine and Topiramate
A Bayesian analysis was performed to derive posterior Bayes individual pharmacokinetic (PK) parameters.
On Days 14, 28, 42, and 56
Apparent Volume of Distribution (Vc/F) of Phentermine and Topiramate
A Bayesian analysis was performed to derive posterior Bayes individual PK parameters.
On Days 14, 28, 42, and 56
Area Under the Curve (AUC) of Phentermine
A Bayesian analysis was performed to derive posterior Bayes individual PK parameters. AUC from time 0 to 24 hours under steady-state.
On Days 14, 28, 42, and 56
Maximum Concentration (Cmax) of Phentermine
A Bayesian analysis was performed to derive posterior Bayes individual PK parameters.
On Days 14, 28, 42, and 56
Area Under the Curve (AUC) of Topiramate
A Bayesian analysis was performed to derive posterior Bayes individual PK parameters. AUC from time 0 to 24 hours under steady-state.
On Days 14, 28, 42, and 56
Maximum Concentration (Cmax) of Topiramate
A Bayesian analysis was performed to derive posterior Bayes individual PK parameters.
On Days 14, 28, 42, and 56
Secondary Outcomes (9)
Weight Loss
56 days
Change in Waist Circumference
56 days
Change in Blood Pressure
56 days
Change in OGTT of Fasting and 2-hour Glucose
56 days
Change in Lipid Parameters
56 days
- +4 more secondary outcomes
Study Arms (3)
Placebo
PLACEBO COMPARATORDays 1-56: Placebo
VI-0521 Mid Dose
EXPERIMENTAL* Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg) * Days 15-56: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)
VI-0521 Top Dose
EXPERIMENTAL* Days 1-14: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg) * Days 15-28: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg) * Days 29-42: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg) * Days 43-56: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)
Interventions
Eligibility Criteria
You may qualify if:
- Provide written informed consent;
- Provide written assent (of study subject);
- Adolescent ≥12 and \<18 years of age;
- Have a BMI ≥ the 95th percentile of BMI for age and gender;
- Female subjects must be using adequate contraception;
- Willing and able to comply with all study requirements
You may not qualify if:
- Condition or disease interfering with metabolism;
- Any medical treatment with insulin;
- Hyperthyroidism, or clinically significant hypothyroidism;
- Any history of bipolar disorder or psychosis, major depressive disorder, or history of suicidal behavior or ideation, or any use of antidepressant medications;
- Use of chronic systemic glucocorticoid or steroid therapy;
- History of any eating disorders;
- Any history of laxative abuse;
- Prior bariatric surgery;
- Any history of nephrolithiasis;
- Any history of epilepsy, or treatment with anti-seizure medications;
- Positive urine drug screen;
- Current smoker or smoking cessation within the previous 3 months of screening;
- Obesity of a known genetic or endocrine origin;
- Treatment with any over-the-counter or prescription weight loss drug, or attention-deficit/hyperactivity disorder (ADHD);
- Allergy or hypersensitivity to phentermine or topiramate or history of anaphylaxis to any drug;
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- VIVUS LLClead
Study Sites (4)
Research Facility
Baton Rouge, Louisiana, 70808, United States
Research Facility
Marrero, Louisiana, 70072, United States
Research Facility
Cincinnati, Ohio, 45229, United States
Research Facility
Charleston, South Carolina, 29403, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sr. Director, Clinical Research
- Organization
- VIVUS
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel Hsia, M.D.
Pennington Biomedical Research
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2016
First Posted
March 21, 2016
Study Start
March 1, 2016
Primary Completion
October 1, 2016
Study Completion
November 1, 2016
Last Updated
August 23, 2022
Results First Posted
February 5, 2018
Record last verified: 2022-08