NCT03922945

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
223

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2019

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

April 16, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 22, 2019

Completed
10 days until next milestone

Study Start

First participant enrolled

May 2, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 16, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 16, 2021

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

September 10, 2022

Completed
Last Updated

September 10, 2022

Status Verified

August 1, 2022

Enrollment Period

2 years

First QC Date

April 16, 2019

Results QC Date

July 19, 2022

Last Update Submit

August 17, 2022

Conditions

Adolescent ObesityObesity in AdolescenceAdolescent Overweight

Keywords

weight lossobesityweight control

Outcome Measures

Primary Outcomes (1)

  • Mean % Change in Body Mass Index (BMI)

    Mean % change in BMI from Baseline to Week 56

    Baseline to Week 56

Secondary Outcomes (10)

  • 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

    Baseline, Week 56

  • Change in Whole Body Insulin Sensitivity Index (WBISI) (Matsuda) at Week 56

    Baseline, Week 56

  • +5 more secondary outcomes

Study Arms (3)

VI-0521 Mid Dose (Phentermine 7.5 mg +Topiramate 46 mg)

EXPERIMENTAL

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 capsuleBehavioral: Lifestyle Modification

VI-0521 Top Dose (Phentermine 15 mg + Topiramate 92 mg)

EXPERIMENTAL

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 capsuleBehavioral: Lifestyle Modification

Placebo

PLACEBO COMPARATOR

Subjects will receive placebo oral capsule, once daily for up to 56 weeks

Drug: Placebo oral capsuleBehavioral: Lifestyle Modification

Interventions

VI-0521 oral capsuleDRUG

Phentermine/Topiramate

Also known as: Qsymia, Phentermine and topiramate
VI-0521 Mid Dose (Phentermine 7.5 mg +Topiramate 46 mg)VI-0521 Top Dose (Phentermine 15 mg + Topiramate 92 mg)
Placebo oral capsuleDRUG

Inactive drug

Placebo
Lifestyle ModificationBEHAVIORAL

The lifestyle modification includes physical activity, behavior change, reduced calorie diet advice, and family support. This intervention is applied to all treatment groups.

PlaceboVI-0521 Mid Dose (Phentermine 7.5 mg +Topiramate 46 mg)VI-0521 Top Dose (Phentermine 15 mg + Topiramate 92 mg)

Eligibility Criteria

Age12 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Intend Research, LLC

Norman, Oklahoma, 73069, United States

Location

Related Publications (1)

  • Kelly AS, Bensignor MO, Hsia DS, Shoemaker AH, Shih W, Peterson C, Varghese ST. Phentermine/Topiramate for the Treatment of Adolescent Obesity. NEJM Evid. 2022 Jun;1(6):10.1056/evidoa2200014. doi: 10.1056/evidoa2200014. Epub 2022 Apr 30.

    PMID: 36968652DERIVED

MeSH Terms

Conditions

Pediatric ObesityWeight LossObesity

Interventions

Qsymia

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Results Point of Contact

Title
Sr. Director, Clinical Research
Organization
VIVUS
clinical@vivus.com
650-934-5200

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2019

First Posted

April 22, 2019

Study Start

May 2, 2019

Primary Completion

April 16, 2021

Study Completion

April 16, 2021

Last Updated

September 10, 2022

Results First Posted

September 10, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)