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

Vivus

Status and phase: Completed; Phase 4

Conditions: Adolescent Overweight; Obesity in Adolescence; Adolescent Obesity

Treatments: Drug: VI-0521 oral capsule; Behavioral: Lifestyle Modification; Drug: Placebo oral capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT03922945

OB-403

Details and patient eligibility

About

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.

Enrollment: 223 patients

Sex: All

Ages: 12 to 16 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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223 participants in 3 patient groups, including a placebo group

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

Experimental group

Description:

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

Treatment:

Drug: VI-0521 oral capsule

Behavioral: Lifestyle Modification

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

Experimental group

Description:

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

Treatment:

Drug: VI-0521 oral capsule

Behavioral: Lifestyle Modification

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo oral capsule

Behavioral: Lifestyle Modification