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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

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ClinicalTrials.gov Identifier: NCT03338296
Recruitment Status : Terminated (Study was terminated as Eisai agreed to voluntarily withdraw Belviq XR from US market.)
First Posted : November 9, 2017
Last Update Posted : February 12, 2021
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obesity Drug: lorcaserin hydrochloride XR Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 278 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 52 Week Randomized, Double-Blind, Placebo-Controlled, Parallel Group 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
Actual Study Start Date : September 28, 2017
Actual Primary Completion Date : March 30, 2020
Actual Study Completion Date : April 14, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Lorcaserin hydrochloride XR 20 mg QD
Participants will receive lorcaserin hydrochloride extended release (XR) 20 milligrams (mg) once daily (QD) for up to 52 weeks.
Drug: lorcaserin hydrochloride XR
oral tablet
Other Name: Belviq XR®

Placebo Comparator: Placebo
Participants will receive placebo QD for up to 52 weeks.
Drug: Placebo
oral tablet




Primary Outcome Measures :
  1. Change in Body Mass Index (BMI) from Baseline to Week 52 [ Time Frame: Baseline; Week 52 ]
    Change from Baseline is calculated as the post-Baseline value minus the Baseline value.


Secondary Outcome Measures :
  1. Percentage of Participants Achieving at Least a 5% BMI Reduction at Week 52 [ Time Frame: Baseline; Week 52 ]
    To measure reduction, Week 52 values are compared to Baseline values.

  2. Percentage of Participants Achieving at Least a 5% BMI Reduction at Week 12 [ Time Frame: Baseline; Week 12 ]
    To measure reduction, Week 12 values are compared to Baseline values.

  3. Percentage of Participants Achieving at Least a 10% BMI Reduction at Week 52 [ Time Frame: Baseline; Week 52 ]
    To measure reduction, Week 52 values are compared to Baseline values.

  4. Percentage Change in BMI from Baseline to Week 52 [ Time Frame: Baseline; Week 52 ]
    Percent change from Baseline is calculated as: ([post-Baseline value minus the Baseline value] / Baseline value) × 100.

  5. Number of Participants With the Indicated Change in BMI from Baseline to Week 52 who also had the Outcome of Achieving at Least a 5% BMI Reduction at Week 12 [ Time Frame: Baseline; Week 52 ]
    Change from Baseline is calculated as the post-Baseline value minus the Baseline value.

  6. Number of Participants With the Indicated Percent Change in BMI from Baseline to Week 52 who also had the Outcome of Achieving at Least a 5% BMI Reduction at Week 12 [ Time Frame: Baseline; Week 52 ]
    Percent change from Baseline is calculated as: ([post-Baseline value minus the Baseline value] / Baseline value) × 100.

  7. Percentage of Participants Achieving at Least a 5% or 10% BMI Reduction at Week 52 who also Achieved at Least a 5% BMI Reduction at Week 12 [ Time Frame: Baseline; Week 52 ]
    To measure reduction, Week 52 values are compared to Baseline values.

  8. Change in Waist Circumference from Baseline to Week 52 [ Time Frame: Baseline; Week 52 ]
    Change from Baseline is calculated as the post-Baseline value minus the Baseline value.

  9. Change in Total Body Fat from Baseline to Week 52 Using Dual-energy X-ray Absorptiometry (DEXA) [ Time Frame: Baseline; Week 52 ]
    Change from Baseline is calculated as the post-Baseline value minus the Baseline value.

  10. Change in Total Lean Mass from Baseline to Week 52 Using DEXA [ Time Frame: Baseline; Week 52 ]
    Change from Baseline is calculated as the post-Baseline value minus the Baseline value.

  11. Change in Hemoglobin A1c (HbA1c) from Baseline to Week 52 for Participants With Type 2 Diabetes at Baseline [ Time Frame: Baseline; Week 52 ]
    Change in HbA1c is analyzed for participants with Type 2 diabetes at Baseline. Change from Baseline is calculated as the post-Baseline value minus the Baseline value.

  12. Change in Fasting Plasma Glucose from Baseline to Week 52 for Participants With Type 2 Diabetes at Baseline [ Time Frame: Baseline; Week 52 ]
    Change in fasting plasma glucose is analyzed for participants with Type 2 diabetes at Baseline. Change from Baseline is calculated as the post-Baseline value minus the Baseline value.

  13. Change in Fasting Insulin from Baseline to Week 52 for Participants With Type 2 Diabetes at Baseline [ Time Frame: Baseline; Week 52 ]
    Change in fasting insulin is analyzed for participants with Type 2 diabetes at Baseline. Change from Baseline is calculated as the post-Baseline value minus the Baseline value.

  14. Change in Homeostatic Model Assessment-insulin Resistance (HOMA-IR) from Baseline to Week 52 for Participants With Type 2 Diabetes at Baseline [ Time Frame: Baseline; Week 52 ]
    Change in HOMA-IR is analyzed for participants with Type 2 diabetes at Baseline. Change from Baseline is calculated as the post-Baseline value minus the Baseline value.

  15. Change in Fasting Plasma Glucose from Baseline to Week 52 for Participants Without Type 2 Diabetes at Baseline [ Time Frame: Baseline; Week 52 ]
    Change in fasting glucose is analyzed for participants without Type 2 diabetes at Baseline. Change from Baseline is calculated as the post-Baseline value minus the Baseline value.

  16. Change in Fasting Insulin from Baseline to Week 52 for Participants Without Type 2 Diabetes at Baseline [ Time Frame: Baseline; Week 52 ]
    Change in fasting insulin is analyzed for participants without Type 2 diabetes at Baseline. Change from Baseline is calculated as the post-Baseline value minus the Baseline value.

  17. Change in HOMA-IR from Baseline to Week 52 for Participants Without Type 2 Diabetes at Baseline [ Time Frame: Baseline; Week 52 ]
    Change in HOMA-IR is analyzed for participants without Type 2 diabetes at Baseline. Change from Baseline is calculated as the post-Baseline value minus the Baseline value.

  18. Change in Blood Pressure (Systolic and Diastolic) from Baseline to Week 52 [ Time Frame: Baseline; Week 52 ]
    Change from Baseline is calculated as the post-Baseline value minus the Baseline value.

  19. Change in Heart Rate from Baseline to Week 52 [ Time Frame: Baseline; Week 52 ]
    Change from Baseline is calculated as the post-Baseline value minus the Baseline value.

  20. Change in Fasting Lipid Profile (Total Cholesterol, low-density Lipoprotein [LDL] Cholesterol, High-density Lipoprotein [HDL] Cholesterol, Triglycerides) from Baseline to Week 52 [ Time Frame: Baseline; Week 52 ]
    Change from Baseline is calculated as the post-Baseline value minus the Baseline value.

  21. Percentage of Participants With Prehypertension or Primary Hypertension at Week 52 [ Time Frame: Week 52 ]
    Hypertension is defined as abnormally high blood pressure.

  22. Percentage of Participants With Dyslipidemia at Week 52 [ Time Frame: Week 52 ]
    Dyslipidemia is defined as abnormally high cholesterol.

  23. Participant Compliance Rate at Each Visit by Pill Count During 52 Weeks of Treatment [ Time Frame: up to Week 52 ]
    The participant compliance rate is analyzed during each visit by counting the number of pills participants take.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male or female adolescents, age 12 to 17 years (inclusive) at Screening, with a body mass index (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

Exclusion Criteria:

  • 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
      • St. John's Wort
      • tryptophan
      • linezolid
      • dextromethorphan in any form (eg, OTC cold medicines)
      • lithium
      • tramadol
      • antipsychotics or other dopamine antagonists
    • Others

      • antiseizure medications including valproic acid, zonisamide, topiramate, and lamotrigine
      • oral steroids (topical and inhaled steroids are acceptable)
      • stimulant medications (eg, Ritalin, Concerta, Biphetamine, and Dexedrine)
      • benzodiazepines
  • Use of drugs known to increase the risk for cardiac valvulopathy within 6 months before Screening, including but not limited to pergolide, ergotamine, methysergide, and cabergoline
  • History or evidence of clinically significant disease (eg, malignancy; cardiac, respiratory, gastrointestinal, renal, or psychiatric disease) other than prediabetes (impaired fasting glucose or impaired glucose tolerance), type 2 diabetes treated with oral anti-diabetic agents (excluding sulfonylurea) or non-insulin injectable antidiabetic agents, obstructive sleep apnea, dyslipidemia, and nonalcoholic fatty liver disease
  • Use of Belviq XR within 6 months before Screening or hypersensitivity to Belviq XR or any of the excipients
  • Significant change in diet or level of physical activity within 1 month before dosing or change in weight of more than 5 kg within 3 months before Screening
  • Any use of a very-low-calorie (<1000 calories/day) weight loss diet within 6 months before Screening
  • History of alcohol or drug dependence or abuse
  • Recreational drug use within 2 years before Screening
  • Known to be human immunodeficiency virus positive
  • Known to have active viral hepatitis (B or C)
  • Malignancy within 5 years before Screening
  • Unable to attend scheduled visits (eg, lack of transportation) or lack of a caregiver or guardian to supervise study participation
  • Special needs participants who are unable to comprehend study-related instructions (eg, mild to profound mental retardation [intelligence quotient <70], moderate to severe cognitive developmental delay, pervasive development disorders, autism)
  • Ongoing epilepsy or other seizure disorder, or use of medications for a seizure disorder within 6 months of screening or any time between screening and randomization
  • Participants with a blood pressure in the 95th percentile or greater for age, sex, and height on 2 separate readings recorded on 2 separate days. Those participants who had uncontrolled hypertension at Screening can be rescreened more than 1 month after initiation or adjustment of antihypertensive therapy 1 time.
  • Currently enrolled in another clinical study or has used any investigational drug or device within 30 days before providing informed consent
  • Planned bariatric surgery during the study or prior bariatric surgical procedures
  • Not suitable to participate in the study in the opinion of the investigator, including consideration of any existing physical, medical, or mental condition that prevents compliance with the protocol
  • Female participants who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive β-human chorionic gonadotropin test). A separate Baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug.
  • Female participants of childbearing potential who:

    • Had unprotected sexual intercourse within 30 days before study entry and who do not agree to use a highly effective method of contraception (eg, total abstinence, an intrauterine device, a double-barrier method [such as condom plus diaphragm with spermicide], a contraceptive implant, an oral contraceptive, or have a vasectomized partner with confirmed azoospermia) throughout the entire study period and for 28 days after study drug discontinuation
    • Are currently abstinent and do not agree to use a double-barrier method (as described above) or refrain from sexual activity during the study period and for 28 days after study drug discontinuation
    • Are using hormonal contraceptives, but are not on a stable dose of the same hormonal contraceptive product for at least 4 weeks before dosing and who do not agree to use the same contraceptive during the study and for 28 days after study drug discontinuation (Note: All female participants will be considered to be of childbearing potential unless they have been sterilized surgically [ie, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing]).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03338296


Locations
Show Show 17 study locations
Sponsors and Collaborators
Eisai Inc.
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Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT03338296    
Other Study ID Numbers: APD356-A001-403
First Posted: November 9, 2017    Key Record Dates
Last Update Posted: February 12, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eisai Inc.:
body mass index
weight loss
adolescents
lifestyle modification
Additional relevant MeSH terms:
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Weight Loss
Body Weight Changes
Body Weight