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

Adolescent Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03922945
• Other study ID #: OB-403
• Status: Completed
• Phase: Phase 4
• Start date: May 2, 2019
• Est. completion date: April 16, 2021

Study information

• Verified date: August 2022
• Source: VIVUS LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 223
• Est. completion date: April 16, 2021
• Est. primary completion date: April 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adolescent Obesity
• Adolescent Overweight
• Obesity
• Obesity in Adolescence
• Overweight
• Pediatric Obesity

Intervention

Drug:
• VI-0521 oral capsule
Phentermine/Topiramate
• 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.

Locations

Country	Name	City	State
United States	Intend Research, LLC	Norman	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
VIVUS LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean % Change in Body Mass Index (BMI)	Mean % change in BMI from Baseline to Week 56	Baseline to Week 56
Secondary	Percentage of Subjects Achieving at Least 5% BMI Reduction at Week 56		Baseline to Week 56
Secondary	Percentage of Subjects Achieving at Least 10% BMI Reduction at Week 56		Baseline to Week 56
Secondary	Percentage of Subjects Achieving at Least 15% BMI Reduction at Week 56		Baseline to Week 56
Secondary	Change in Waist Circumference at Week 56	Change in waist circumference from Baseline to Week 56	Baseline, Week 56
Secondary	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.	Baseline, Week 56
Secondary	Change in Fasting Insulin at Week 56	Change in fasting insulin from Baseline to Week 56	Baseline, Week 56
Secondary	Percent Change in Triglycerides From Baseline to Week 56		Baseline, Week 56
Secondary	Percent Change in HDL-C From Baseline to Week 56		Baseline, Week 56
Secondary	Change From Baseline in Systolic Blood Pressure at Week 56		Baseline, Week 56
Secondary	Change From Baseline in Diastolic Blood Pressure at Week 56		Baseline, Week 56