Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03922945
Other study ID # OB-403
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design


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
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT05530356 - Renal Hemodynamics, Energetics and Insulin Resistance: A Follow-up Study
Recruiting NCT05008276 - Puberty, Diabetes, and the Kidneys, When Eustress Becomes Distress (PANTHER Study)
Not yet recruiting NCT04310371 - Exposure to CARDIovascular Risk Assessed by Cardiac Adiposity in oBese adOlescents Eligible to a Residential Long-term Lifestyle Intervention by Diet and eXercise (CARDIBOX) N/A
Not yet recruiting NCT03203161 - Registry on Obesity Surgery in Adolescents
Completed NCT03364205 - Solution Focused Approach in Adolescents (SFA) N/A
Recruiting NCT04837586 - Self-Weighing for Adolescents Seeking Obesity Treatment N/A
Completed NCT05329753 - Effectiveness of a Mobile Health Intervention for the Prevention of Overweight and Obesity in Adolescents N/A
Active, not recruiting NCT03843424 - Treatment Efforts Addressing Child Weight Management by Unifying Patients, Parents & Providers N/A
Completed NCT03516097 - TeenPower: e-Empowering Teenagers to Prevent Obesity N/A
Active, not recruiting NCT04522921 - Childhood Obesity - Prevention of Diabetes Through Changed Eating Patterns N/A
Active, not recruiting NCT03584217 - Renal HEIR Study: Renal Hemodynamics, Energetics and Insulin Resistance in Youth Onset Type 2 Diabetes Study Phase 1/Phase 2
Active, not recruiting NCT03620773 - Impact of Metabolic Surgery on Pancreatic, Renal and Cardiovascular Health in Youth With Type 2 Diabetes Phase 1/Phase 2
Recruiting NCT03263351 - Depression & Insulin Sensitivity in Adolescents N/A
Completed NCT03458637 - Lifestyle Intervention of Obese Teenagers (LITE) Program N/A
Recruiting NCT05540678 - The FibreGum Study - Changing the Course of Obesity in Children N/A
Active, not recruiting NCT04007393 - SMART Use of Medication for the Treatment of Adolescent Severe Obesity Phase 2
Active, not recruiting NCT03587727 - Hepatic Mitochondrial Function in Youth
Not yet recruiting NCT04112251 - Effects of COcoa Supplement in OBese Adolescent Subjects N/A
Recruiting NCT05623007 - Dietary Modulation of Gut Microbiota in Overweight/Obese Adolescents and COVID-19 Infection N/A
Completed NCT03516721 - Chronotropic Incompetence During Exercise in Obese Adolescents: Clinical Implications and Pathophysiology N/A