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

Eisai Inc.16 sites in 1 country278 target enrollmentSeptember 28, 2017

ConditionsObesity

Interventionslorcaserin hydrochloride XR Placebo

Drugslorcaserin hydrochloride XR Placebo

Overview

Phase: Phase 4
Intervention: lorcaserin hydrochloride XR
Conditions: Obesity
Sponsor: Eisai Inc.
Enrollment: 278
Locations: 16
Primary Endpoint: Change in Body Mass Index (BMI) From Baseline up to Week 52
Status: Terminated
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 28, 2017

End Date

April 3, 2020

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Eisai Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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:

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

Arms & Interventions

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.

Intervention: lorcaserin hydrochloride XR

Placebo

Participants will receive placebo QD for up to 52 weeks.

Intervention: Placebo

Outcomes

Primary Outcomes

Change in Body Mass Index (BMI) From Baseline up to Week 52

Time Frame: Baseline up to Week 52

BMI is a participant's weight in kilograms divided by the square of height in meters. Change from baseline was calculated as the post-baseline value minus the baseline value.

Secondary Outcomes

Change in BMI From Baseline up to Week 52 in Participants Who Also Had the Outcome of Achieving at Least a 5% BMI Reduction at Week 12(Baseline up to Week 52)
Percent Change in BMI From Baseline up to Week 52 in Participants Who Also Had the Outcome of Achieving at Least a 5% BMI Reduction at Week 12(Baseline up to Week 52)
Number of Participants Who Achieved at Least a 5% or 10% BMI Reduction up to Week 52 Who Also Achieved at Least a 5% BMI Reduction at Week 12(Baseline up to Week 52)
Change in Total Body Lean Mass From Baseline up to Week 52 Using DEXA(Baseline up to Week 52)
Percent Change in Hemoglobin A1c (HbA1c) From Baseline up to Week 52 in Participants With Type 2 Diabetes Mellitus at Baseline(Baseline up to Week 52)
Change in Fasting Insulin From Baseline up to Week 52 in Participants Without Type 2 Diabetes Mellitus at Baseline(Baseline up to Week 52)
Percentage of Participants Who Achieved at Least a 10% BMI Reduction at Week 52(Baseline up to Week 52)
Change in Waist Circumference From Baseline up to Week 52(Baseline up to Week 52)
Change in Total Body Fat Mass From Baseline up to Week 52 Using Dual-energy X-ray Absorptiometry (DEXA)(Baseline up to Week 52)
Change in Fasting Plasma Glucose From Baseline up to Week 52 for Participants With Type 2 Diabetes Mellitus at Baseline(Baseline up to Week 52)
Change in Blood Pressure (Systolic and Diastolic) From Baseline up to Week 52(Baseline up to Week 52)
Change in Heart Rate From Baseline up to Week 52(Baseline up to Week 52)
Percentage of Participants by Study Drug Compliance Category During 52 Weeks of Treatment(Up to Week 52)
Percentage of Participants Who Achieved at Least a 5 Percent (%) BMI Reduction at Week 52(Baseline up to Week 52)
Percent Change in BMI From Baseline up to Week 52(Baseline up to Week 52)
Percentage of Participants With Dyslipidemia at Week 52(Week 52)
Percentage of Participants Who Achieved at Least a 5% BMI Reduction at Week 12(Baseline up to Week 12)
Change in Fasting Insulin From Baseline up to Week 52 for Participants With Type 2 Diabetes Mellitus at Baseline(Baseline up to Week 52)
Change in Homeostatic Model Assessment-insulin Resistance (HOMA-IR) From Baseline up to Week 52 for Participants With Type 2 Diabetes Mellitus at Baseline(Baseline up to Week 52)
Change in Fasting Plasma Glucose From Baseline up to Week 52 in Participants Without Type 2 Diabetes Mellitus at Baseline(Baseline up to Week 52)
Change in HOMA-IR From Baseline up to Week 52 in Participants Without Type 2 Diabetes Mellitus at Baseline(Baseline up to Week 52)
Change in Fasting Lipid Profile (Total Cholesterol, Low-density Lipoprotein [LDL] Cholesterol, High-density Lipoprotein [HDL] Cholesterol, Triglycerides) From Baseline up to Week 52(Baseline up to Week 52)
Percentage of Participants With Prehypertension or Primary Hypertension at Week 52(Week 52)