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

NCT03338296 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: APD356-A001-403
• Study Type: interventional
• Target: 278
• Locations: 1 country
• Sites: 16

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.

Conditions

Obesity

Keywords

body mass index; weight loss; adolescents; lifestyle modification

Outcome Measures

Primary Outcomes (1)

• Change in Body Mass Index (BMI) From 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.

  Baseline up to Week 52

Secondary Outcomes (23)

• Percentage of Participants Who Achieved at Least a 5 Percent (%) BMI Reduction at Week 52

  Baseline up to Week 52

• Percentage of Participants Who Achieved at Least a 5% BMI Reduction at Week 12

  Baseline up to Week 12

• Percentage of Participants Who Achieved at Least a 10% 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

• 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

Study Arms (2)

Lorcaserin hydrochloride XR 20 mg QD

EXPERIMENTAL

Participants will receive lorcaserin hydrochloride extended release (XR) 20 milligrams (mg) once daily (QD) for up to 52 weeks.

Drug: lorcaserin hydrochloride XR

Placebo

PLACEBO COMPARATOR

Participants will receive placebo QD for up to 52 weeks.

Drug: Placebo

Interventions

lorcaserin hydrochloride XR DRUG

oral tablet

Also known as: Belviq XR®

Lorcaserin hydrochloride XR 20 mg QD

Placebo DRUG

oral tablet

Placebo

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

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)
• 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

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (16)

Phoenix Clinical LLC

Phoenix, Arizona, 85014, United States

Location

Alliance Research Institute

Bell Gardens, California, 90201, United States

Location

Long Beach Clinical Trial Services, Inc

Long Beach, California, 90806, United States

Location

International Research Partners LLC

Doral, Florida, 33122, United States

Location

Oviedo Medical Research, LLC

Oviedo, Florida, 32765, United States

Location

Gwinnett Research Institute

Buford, Georgia, 30519, United States

Location

Columbus Regional Research Institute

Columbus, Georgia, 31904, United States

Location

Buynak Clinical Research, PC

Valparaiso, Indiana, 46383, United States

Location

Heartland Research Associates, LLC

Wichita, Kansas, 67207, United States

Location

The Center for Pharmaceutical Research, LLC

Kansas City, Missouri, 64114, United States

Location

Wake Research-Clinical Research Center of Nevada, LLC

Henderson, Nevada, 89014, United States

Location

Diabetes & Endocrinology Consultants, PC

Morehead City, North Carolina, 28557, United States

Location

Neuro-Behavioral Clinical Research, Inc

North Canton, Ohio, 44720, United States

Location

Celia Reyes-Acuna, MD

Corpus Christi, Texas, 78413, United States

Location

DCT-McAllen Primary Care, LLC dba Discovery Clinical Trials

McAllen, Texas, 78503, United States

Location

National Clinical Research-Richmond, Inc

Richmond, Virginia, 23294, United States

Location

MeSH Terms

Conditions

Obesity; Weight Loss

Interventions

lorcaserin

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Limitations and Caveats

This study was terminated as Eisai agreed to voluntarily withdraw Belviq extended release (XR) from the United States market after a request from the Food and Drug Administration based on the Agency's analysis of data from the CAMELIA-TIMI 61 cardiovascular outcomes study (NCT02019264).

Results Point of Contact

• Title: Eisai Medical Information
• Organization: Eisai Inc.

esi_medinfo@eisai.com

1-888-274-2378

Publication Agreements

• PI is Sponsor Employee: No
• 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: November 7, 2017
• First Posted: November 9, 2017
• Study Start: September 28, 2017
• Primary Completion: April 3, 2020
• Study Completion: April 3, 2020
• Last Updated: July 19, 2021
• Results First Posted: July 19, 2021

Record last verified: 2021-05

Locations

US (16)