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

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

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.

Study Overview

• Status: Completed
• Conditions: Adolescent Obesity; Obesity in Adolescence; Adolescent Overweight
• Intervention / Treatment: Drug: VI-0521 oral capsule; Behavioral: Lifestyle Modification; Drug: Placebo oral capsule

• Study Type: Interventional
• Enrollment (Actual): 223
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Norman, Oklahoma, United States, 73069
      • Intend Research, LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / 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	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.; Drug: Placebo oral capsule; Inactive drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean % Change in Body Mass Index (BMI)	Mean % change in BMI from Baseline to Week 56	Baseline to Week 56

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects Achieving at Least 5% BMI Reduction at Week 56		Baseline to Week 56
Percentage of Subjects Achieving at Least 10% BMI Reduction at Week 56		Baseline to Week 56
Percentage of Subjects Achieving at Least 15% BMI Reduction at Week 56		Baseline to Week 56
Change in Waist Circumference at Week 56	Change in waist circumference from Baseline to Week 56	Baseline, Week 56
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
Change in Fasting Insulin at Week 56	Change in fasting insulin from Baseline to Week 56	Baseline, Week 56
Percent Change in Triglycerides From Baseline to Week 56		Baseline, Week 56
Percent Change in HDL-C From Baseline to Week 56		Baseline, Week 56
Change From Baseline in Systolic Blood Pressure at Week 56		Baseline, Week 56
Change From Baseline in Diastolic Blood Pressure at Week 56		Baseline, Week 56

Collaborators and Investigators

• Sponsor: VIVUS LLC

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2019
• Primary Completion (Actual): April 16, 2021
• Study Completion (Actual): April 16, 2021

Study Registration Dates

• First Submitted: April 16, 2019
• First Submitted That Met QC Criteria: April 18, 2019
• First Posted (Actual): April 22, 2019

Study Record Updates

• Last Update Posted (Actual): September 10, 2022
• Last Update Submitted That Met QC Criteria: August 17, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: obesity; weight loss; weight control
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Obesity; Pediatric Obesity; Overweight; Hypoglycemic Agents; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anticonvulsants; Appetite Depressants; Anti-Obesity Agents; Central Nervous System Stimulants; Sympathomimetics; Topiramate; Phentermine
• Other Study ID Numbers: OB-403

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No