Study to Evaluate the Efficacy and Safety of Belviq XR® in Conjunction With Lifestyle Modification for Weight Loss in Obese Adolescents, Age 12 to 17 Years

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Obesity

In brief

This study will be conducted to demonstrate weight loss efficacy by change in body mass index (BMI) and safety in adolescents age 12 to 17 years (inclusive) during 52 weeks of treatment with Belviq XR 20 milligrams (mg) administered once daily (QD) as compared to placebo.

Key facts

Study ID

NCT03338296

Run by

Eisai Inc.

People needed

278

Starts

2017-09-28

Expected to finish

2020-04-03

Last updated by the study team

2021-07-19

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy male or female adolescents, age 12 to 17 years (inclusive) at Screening, with a BMI that is greater than or equal to the United States-weighted mean of the 95th percentile based on age and sex with a body weight greater than 60 kilograms (kg). Participants with Type 2 diabetes mellitus (T2DM) may have a pre-existing or new diagnosis of T2DM.
• Participants with pre-existing T2DM should have prior documentation consistent with the diagnosis and/or be on active pharmacotherapy for T2DM.
• Participants with a new diagnosis of T2DM (ie, diagnosed at Screening) should be based on the 2016 American Diabetes Association (ADA) guidelines. The diagnostic criteria are met if a participant has unequivocal hyperglycemia (random plasma glucose ≥200 milligrams per deciliter (mg/dL) (11.1 millimoles per liter [mmol/L]) with classic symptoms of hyperglycemia or hyperglycemic crisis) OR any of the following criteria are observed and confirmed:
• HbA1c ≥6.5%
• fasting plasma glucose (FPG) ≥126 mg/dL (7.0 mmol/L)
• 2-hour plasma glucose ≥200 mg/dL (11.1 mmol/L) by an oral glucose tolerance test (OGTT) All T2DM participants must have an HbA1c <10% at Screening. If participants are being or need to be treated with antidiabetic agents, the T2DM treatment regimen must be stable for at least 3 months before randomization. A single rescreen is allowed following stabilization. Stable control refers to minimal dose changes to existing medications for glycemic control and no medications being initiated for glycemic control in the 3 months before randomization. Minimal changes are defined as a change without any change in dose frequency, no add-on or discontinuation of other antidiabetic agents and the participant has not been hospitalized due to hypo- or hyperglycemic events.
• Participants and their families not planning to move away from the area for the duration of the study
• Participants able and willing to comply with all aspects of the study, including a standardized, reduced calorie diet and an age appropriate, increased physical activity program
• Participants considered in stable health in the opinion of the investigator
• Caregivers or guardians meet the following requirements:
• Able and willing to support and supervise study participation in the opinion of the investigator, including consideration of any existing physical, medical, or mental condition that prevents compliance with the protocol
• Able and willing to personally comply with and execute all aspects of the study requirements for the caregivers or guardians

You may not qualify if…

• Clinically significant new illness within 1 month before randomization that may affect the participant's ability to fulfill the study requirements or significantly confound the assessments
• Participants who cannot swallow investigational products
• Participants with T2DM who have hypoglycemia unawareness
• Any of the following findings on Screening echocardiography:
• Aortic regurgitation mild or greater
• Mitral regurgitation moderate or greater
• Mitral or aortic valve stenosis greater than mild (ie, aortic stenosis: jet >3.0 meters per second [m/s], mean gradient >25 millimeters of mercury [mmHg], and aortic valve area <1.5 centimeters squared [cm\^2]; mitral stenosis: mean gradient >5 mmHg and mitral valve area <1.5 cm\^2)
• Systolic pulmonary artery pressure (SPAP) >40 mmHg (and/or tricuspid regurgitation [TR] jet velocity >2.9 m/s) In cases where an actual SPAP value is not measurable due to lack of adequate TR jet, the pulmonary flow acceleration time measured at the right ventricular outflow tract (RVOTAT) will be used to assess eligibility. Participants with a RVOTAT ≤100 milliseconds (msec) will be excluded, suggesting an elevated mean SPAP; eligibility for the those participants with RVOTAT between 100 and 120 msec will be determined based on combined assessment of the TR jet, septal motion, and right ventricular size.
• Left ventricular ejection fraction <45%
• Intracardiac mass, tumor, or thrombus
• Evidence of congenital heart disease
• Clinically significant pericardial effusion (eg, moderate or larger or with hemodynamic compromise)
• Significant renal or hepatic disease as evidenced by a serum creatinine greater than 1.5× upper limit of normal (ULN), serum transaminases greater than 3× ULN, or total bilirubin greater than 1.5× ULN in absence of Gilbert's syndrome
• Any suicidal ideation with intent with or without a plan, at the time of or within 6 months of Screening, as indicated by answering "Yes" to questions 4 or 5 on the Suicidal Ideation section of the Columbia-Suicide Severity Rating Scale (C-SSRS)
• Any suicidal behavior in the past based on the C-SSRS
• Any history of anorexia or bulimia within 2 years before Screening, Attention Deficit Hyperactivity Disorder, any Diagnostic and Statistical Manual of Mental Disorders, 5th Edition depressive disorder, bipolar disorder, or schizophrenia
• Known secondary causes (genetic, endocrine, or metabolic) for obesity (eg, Prader-Willi syndrome, Bardet Biedl syndrome, Down's Syndrome, untreated hypothyroidism, Cushing's syndrome, daily systemic corticosteroid exposure for longer than 30 days, history of significant exposure to corticosteroids for chronic illness during the past year; inhaled steroids will be allowed)
• Use of other products intended for weight loss including prescription drugs, over-the-counter (OTC) drugs, and herbal preparations within 1 month before Screening
• Use of any of the following medications:
• Serotonergic drugs within 7 days (or 5 half-lives, whichever is longer) or monoamine oxidase inhibitors within 30 days before Randomization, including:
• selective serotonin reuptake inhibitors
• serotonin norepinephrine reuptake inhibitors
• tricyclic antidepressants
• bupropion
• triptans

Where it is running

• Phoenix Clinical LLC — Phoenix, Arizona, United States
• Alliance Research Institute — Bell Gardens, California, United States
• Long Beach Clinical Trial Services, Inc — Long Beach, California, United States
• International Research Partners LLC — Doral, Florida, United States
• Oviedo Medical Research, LLC — Oviedo, Florida, United States
• Gwinnett Research Institute — Buford, Georgia, United States
• Columbus Regional Research Institute — Columbus, Georgia, United States
• Buynak Clinical Research, PC — Valparaiso, Indiana, United States
• Heartland Research Associates, LLC — Wichita, Kansas, United States
• The Center for Pharmaceutical Research, LLC — Kansas City, Missouri, United States
• Wake Research-Clinical Research Center of Nevada, LLC — Henderson, Nevada, United States
• Diabetes & Endocrinology Consultants, PC — Morehead City, North Carolina, United States
• Neuro-Behavioral Clinical Research, Inc — North Canton, Ohio, United States
• Celia Reyes-Acuna, MD — Corpus Christi, Texas, United States
• DCT-McAllen Primary Care, LLC dba Discovery Clinical Trials — McAllen, Texas, United States
• National Clinical Research-Richmond, Inc — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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