Pediatric ObesityPhase 4NCT02714062

A Pharmacokinetic Study Comparing VI-0521 With Placebo in Obese Adolescents

A Phase 4 study testing VI-0521 Mid Dose and VI-0521 Top Dose in people with Pediatric Obesity and Childhood Obesity, run by VIVUS LLC at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary objective of this study is to describe the pharmacokinetic profiles of VI-0521 in obese adolescents. Read more about this study

Who is it for?: Ages 12 to 17 years
Conditions the study is for: Pediatric Obesity, Childhood Obesity
What is being tested?: VI-0521 Mid Dose and VI-0521 Top Dose
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 42 participants
Where: 4 sitesUnited States
Study dates: Mar 2016to Nov 2016
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

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

Who cannot join

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;

Show all 17Show fewer

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;
Use of any investigational medication or device for any indication or participation in a clinical study within 30 days prior to screening; or
Any medical or surgical condition which would impair the ability of the subject to complete the study, compromise the quality of study data, or pose an unacceptable risk to the safety of the subject.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Research Facility
Baton Rouge, Louisiana, 70808
Research Facility
Charleston, South Carolina, 29403
Research Facility
Cincinnati, Ohio, 45229
Research Facility
Marrero, Louisiana, 70072

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Pharmacokinetic and Pharmacodynamic Study of VI-0521 in Obese Adolescents

The primary objective of this study is to describe the pharmacokinetic profiles of VI-0521 in obese adolescents.

Conditions: Pediatric Obesity, Childhood Obesity
Being tested: Placebo, VI-0521 Mid Dose, VI-0521 Top Dose
Keywords: Adolescent Obesity, Childhood Obesity, Qsymia, Pharmacokinetics, VI-0521, Phentermine, Topiramate
Medical subject headings: Pediatric Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboDrug
Also called Sugar Pill
po once daily
VI-0521 Mid DoseDrug
Also called Phentermine/Topiramate
po once daily
VI-0521 Top DoseDrug
Also called Phentermine/Topiramate
po once daily

Study groups in NCT02714062
Study group	Role	What they receive
Placebo	Placebo comparator	Days 1-56: Placebo Receives: Drug: 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) Receives: Drug: VI-0521 Mid Dose
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) Receives: Drug: VI-0521 Top Dose

What is being measured

The primary outcome is the main question the study is designed to answer.

Apparent Clearance (CL/F) of Phentermine and Topiramate
A Bayesian analysis was performed to derive posterior Bayes individual pharmacokinetic (PK) parameters.
Measured: 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.
Measured: 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.
Measured: On Days 14, 28, 42, and 56
Maximum Concentration (Cmax) of Phentermine
A Bayesian analysis was performed to derive posterior Bayes individual PK parameters.
Measured: 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.
Measured: On Days 14, 28, 42, and 56
Maximum Concentration (Cmax) of Topiramate
A Bayesian analysis was performed to derive posterior Bayes individual PK parameters.
Measured: On Days 14, 28, 42, and 56

Secondary outcomes (9)

Weight Loss
Mean percent weight change from baseline to Day 56
Measured: 56 days
Change in Waist Circumference
Mean change in waist circumference from baseline to Day 56
Measured: 56 days
Change in Blood Pressure
Mean change in blood pressure from baseline to Day 56
Measured: 56 days
Change in OGTT of Fasting and 2-hour Glucose
Mean changes in glycemic parameters (OGTT of fasting and 2-hour glucose) from baseline to Day 56
Measured: 56 days
Change in Lipid Parameters
Mean percent changes in lipid parameters, including total cholesterol, LDL-C, HDL-C and triglycerides (TG) from baseline to Day 56
Measured: 56 days
Change in Visual Analog Scale (VAS) Hunger Scores
Mean change in visual analog scale (VAS) hunger scores from baseline to Day 56. VAS hunger score is measured using a 10.0 cm horizontal line. The left end of this line is defined by word descriptors "not at all hungry" and corresponds to a VAS hunger score of 0.0. The right end of this line is defined by word descriptors "extremely hungry all the time" and corresponds to a VAS hunger score of 10.0. Subjects were asked "Please mark with a perpendicular line on the scale how hungry you were overall during the past week:" to best describes their overall level of hunger during the past week. Research staff measure the distance between the "0.0 = not at all hungry" anchor and the mark made by the subject (length to the nearest tenth of a centimeter) to score the measure.
Measured: 56 days
Change in Visual Analog Scale (VAS) Satiety Scores
Mean change in visual analog scale (VAS) satiety scores from baseline to Day 56. VAS satiety score is measured using a 10.0 cm horizontal line. The left end of this line is defined by word descriptors "very satisfied" and corresponds to a VAS satiety score of 0.0. The right end of this line is defined by word descriptors "not all at satisfied" and corresponds to a VAS satiety score of 10.0. Subjects were asked "Please mark with a perpendicular line on the scale how satisfied you were after eating during the past week:" to evaluate how satisfied subjects are after eating during the past week. Research staff measure the distance between the "0.0 = very satisfied" anchor and the mark made by the subject (length to the nearest tenth of a centimeter) to score the measure.
Measured: 56 days
Change in HOMA-IR
Mean changes in glycemic parameters (HOMA-IR) from baseline to Day 56
Measured: 56 days
Change in Whole Body Insulin Sensitivity Index (WBISI) (Matsuda)
Mean changes in glycemic parameters [Whole Body Insulin Sensitivity Index (WBISI) (Matsuda)] from baseline to Day 56. The Oral Glucose Tolerance Test (OGTT) were performed at Baseline and Day 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.
Measured: 56 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2016Nov 2016

First posted21 Mar 2016 (estimated)
Study startMar 2016
Primary completionOct 2016
Study completionNov 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Pediatric ObesityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02714062
Sponsor's protocol ID: OB-402
Status last verified: Aug 2022
First submitted: 8 Mar 2016
Last updated: 23 Aug 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pediatric Obesity trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo-Controlled, Pharmacokinetic and Pharmacodynamic Study of VI-0521 in Obese Adolescents
ClinicalTrials.gov ID: NCT02714062
Acronym / sponsor ID: OB-402
Conditions: Pediatric Obesity, Childhood Obesity
Keywords: Adolescent Obesity, Childhood Obesity, Qsymia, Pharmacokinetics, VI-0521, Phentermine, Topiramate
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: VIVUS LLCIndustry (pharma, biotech, devices)
Study start: Mar 2016 (actual)
Primary completion: Oct 2016 (actual)
Study completion: Nov 2016 (actual)
First posted: 21 Mar 2016 (estimated)
Results: Posted 5 Feb 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The primary objective of this study is to describe the pharmacokinetic profiles of VI-0521 in obese adolescents.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboDays 1-56: Placebo
VI-0521 Mid Dose	Experimental	Drug: VI-0521 Mid Dose* 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	Drug: VI-0521 Top Dose* 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)

Who may qualify

Ages: 12 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (6 listed)

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;

Key exclusion criteria (17 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PlaceboAlso: Sugar Pillpo once daily	Drug	Placebo
VI-0521 Mid DoseAlso: Phentermine/Topiramatepo once daily	Drug	VI-0521 Mid Dose
VI-0521 Top DoseAlso: Phentermine/Topiramatepo once daily	Drug	VI-0521 Top Dose

Primary outcome

Apparent Clearance (CL/F) of Phentermine and Topiramate
Time frame: On Days 14, 28, 42, and 56
A Bayesian analysis was performed to derive posterior Bayes individual pharmacokinetic (PK) parameters.
Apparent Volume of Distribution (Vc/F) of Phentermine and Topiramate
Time frame: On Days 14, 28, 42, and 56
A Bayesian analysis was performed to derive posterior Bayes individual PK parameters.
Area Under the Curve (AUC) of Phentermine
Time frame: On Days 14, 28, 42, and 56
A Bayesian analysis was performed to derive posterior Bayes individual PK parameters. AUC from time 0 to 24 hours under steady-state.
Maximum Concentration (Cmax) of Phentermine
Time frame: On Days 14, 28, 42, and 56
A Bayesian analysis was performed to derive posterior Bayes individual PK parameters.
Area Under the Curve (AUC) of Topiramate
Time frame: On Days 14, 28, 42, and 56
A Bayesian analysis was performed to derive posterior Bayes individual PK parameters. AUC from time 0 to 24 hours under steady-state.
Maximum Concentration (Cmax) of Topiramate
Time frame: On Days 14, 28, 42, and 56
A Bayesian analysis was performed to derive posterior Bayes individual PK parameters.

9 secondary outcomes

Weight Loss
Time frame: 56 days
Change in Waist Circumference
Time frame: 56 days
Change in Blood Pressure
Time frame: 56 days
Change in OGTT of Fasting and 2-hour Glucose
Time frame: 56 days
Change in Lipid Parameters
Time frame: 56 days
Change in Visual Analog Scale (VAS) Hunger Scores
Time frame: 56 days
Change in Visual Analog Scale (VAS) Satiety Scores
Time frame: 56 days
Change in HOMA-IR
Time frame: 56 days
Change in Whole Body Insulin Sensitivity Index (WBISI) (Matsuda)
Time frame: 56 days

Results and safety

Results posted to the registry on 5 Feb 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	14	13
VI-0521 Mid Dose	15	14
VI-0521 Top Dose	13	10

Primary outcome: Apparent Clearance (CL/F) of Phentermine and Topiramate

Time frame: On Days 14, 28, 42, and 56. Mean (Standard Deviation). Unit: L/h

Measure	VI-0521 Mid Dose n = 15	VI-0521 Top Dose n = 13
Day 14 (Phentermine)	7.33 (1.63)	7.04 (2.65)
Day 28 (Phentermine)	7.33 (1.63)	7.18 (2.57)
Day 42 (Phentermine)	6.82 (1.69)	6.49 (2.15)
Day 56 (Phentermine)	6.82 (1.69)	6.67 (2.18)
Day 14 (Topiramate)	1.32 (0.333)	1.25 (0.307)
Day 28 (Topiramate)	1.32 (0.333)	1.27 (0.300)
Day 42 (Topiramate)	1.25 (0.291)	1.20 (0.257)
Day 56 (Topiramate)	1.25 (0.291)	1.18 (0.265)

Population analysed: PK samples were not collected for some patients due to withdrawal, or missed visits, etc. As a result, number analyzed for some visits is less than overall number analyzed.

Primary outcome: Apparent Volume of Distribution (Vc/F) of Phentermine and Topiramate

Time frame: On Days 14, 28, 42, and 56. Mean (Standard Deviation). Unit: L

Measure	VI-0521 Mid Dose n = 15	VI-0521 Top Dose n = 13
Day 14 (Phentermine)	289 (80.4)	289 (70.4)
Day 28 (Phentermine)	287 (79.8)	291 (69.6)
Day 42 (Phentermine)	284 (79.3)	298 (62.1)
Day 56 (Phentermine)	281 (78.8)	299 (64.6)
Day 14 (Topiramate)	46.8 (17.7)	46.1 (13.5)
Day 28 (Topiramate)	46.2 (17.5)	46.6 (13.5)
Day 42 (Topiramate)	45.7 (17.3)	48.2 (11.5)
Day 56 (Topiramate)	45.2 (17.2)	47.5 (12.3)

Population analysed: PK samples were not collected for some patients due to withdrawal, or missed visits, etc. As a result, number analyzed for some visits is less than overall number analyzed.

Primary outcome: Area Under the Curve (AUC) of Phentermine

Time frame: On Days 14, 28, 42, and 56. Mean (Standard Deviation). Unit: ng•h/mL

Measure	VI-0521 Mid Dose n = 15	VI-0521 Top Dose n = 13
Day 14 (Phentermine)	533 (109)	600 (205)
Day 28 (Phentermine)	1066 (218)	1171 (403)
Day 42 (Phentermine)	1154 (240)	1902 (576)
Day 56 (Phentermine)	1154 (240)	2469 (775)

Population analysed: PK samples were not collected for some patients due to withdrawal, or missed visits, etc. As a result, number analyzed for some visits is less than overall number analyzed.

Primary outcome: Maximum Concentration (Cmax) of Phentermine

Time frame: On Days 14, 28, 42, and 56. Mean (Standard Deviation). Unit: ng/mL

Measure	VI-0521 Mid Dose n = 15	VI-0521 Top Dose n = 13
Day 14 (Phentermine)	27.6 (5.34)	30.3 (9.61)
Day 28 (Phentermine)	55.3 (10.7)	59.3 (19.0)
Day 42 (Phentermine)	59.0 (11.6)	94.2 (25.9)
Day 56 (Phentermine)	59.1 (11.6)	123 (34.8)

Population analysed: PK samples were not collected for some patients due to withdrawal, or missed visits, etc. As a result, number analyzed for some visits is less than overall number analyzed.

9 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 14 (0%)	7 of 14 (50%)	0 of 14
VI-0521 Mid Dose	0 of 15 (0%)	6 of 15 (40%)	0 of 15
VI-0521 Top Dose	1 of 13 (7.7%)	10 of 13 (76.9%)	0 of 13

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Daniel Hsia, M.D. principal investigator

Pennington Biomedical Research

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing VI-0521 Mid Dose and VI-0521 Top Dose in people with Pediatric Obesity and Childhood Obesity, run by VIVUS LLC at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Apparent Clearance (CL/F) of Phentermine and Topiramate (time frame: On Days 14, 28, 42, and 56). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02714062.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2022.