ObesityPhase 4NCT03338296
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
A Phase 4 study testing lorcaserin hydrochloride XR in people with Obesity, run by Eisai Inc. at 16 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- lorcaserin hydrochloride XR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 278 participants
- Where
- 16 sitesUnited States
- Study dates
- 28 Sep 2017to 3 Apr 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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]).
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Alliance Research Institute
Bell Gardens, California, 90201
Gwinnett Research Institute
Buford, Georgia, 30519
Columbus Regional Research Institute
Columbus, Georgia, 31904
Celia Reyes-Acuna, MD
Corpus Christi, Texas, 78413
International Research Partners LLC
Doral, Florida, 33122
Wake Research-Clinical Research Center of Nevada, LLC
Henderson, Nevada, 89014
The Center for Pharmaceutical Research, LLC
Kansas City, Missouri, 64114
Long Beach Clinical Trial Services, Inc
Long Beach, California, 90806
DCT-McAllen Primary Care, LLC dba Discovery Clinical Trials
McAllen, Texas, 78503
Diabetes & Endocrinology Consultants, PC
Morehead City, North Carolina, 28557
Neuro-Behavioral Clinical Research, Inc
North Canton, Ohio, 44720
Oviedo Medical Research, LLC
Oviedo, Florida, 32765
Phoenix Clinical LLC
Phoenix, Arizona, 85014
National Clinical Research-Richmond, Inc
Richmond, Virginia, 23294
Buynak Clinical Research, PC
Valparaiso, Indiana, 46383
Heartland Research Associates, LLC
Wichita, Kansas, 67207
About this study
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
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
- Being tested
- lorcaserin hydrochloride XR, Placebo
- Keywords
- body mass index, weight loss, adolescents, lifestyle modification
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lorcaserin hydrochloride XRDrug
Also called Belviq XR®
oral tablet
PlaceboDrug
oral tablet
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: lorcaserin hydrochloride XR |
| Placebo | Placebo comparator | Participants will receive placebo QD for up to 52 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline up to Week 52
Secondary outcomes (23)
Percentage of Participants Who Achieved at Least a 5 Percent (%) BMI Reduction at Week 52
Measured: Baseline up to Week 52
Percentage of Participants Who Achieved at Least a 5% BMI Reduction at Week 12
Measured: Baseline up to Week 12
Percentage of Participants Who Achieved at Least a 10% BMI Reduction at Week 52
Measured: Baseline up to Week 52
Percent Change in BMI From Baseline up to Week 52
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline up to Week 52
Change in Waist Circumference From Baseline up to Week 52
Measured: Baseline up to Week 52
Change in Total Body Fat Mass From Baseline up to Week 52 Using Dual-energy X-ray Absorptiometry (DEXA)
DEXA is used to assess changes in body composition, including total fat and lean body mass and appendicular skeletal fat and muscle mass. DEXA instruments has a source that generates x-rays split into two energies which measures bone mineral mass and soft tissue from which fat and fat-free mass (or lean body mass) are estimated.
Measured: Baseline up to Week 52
Change in Total Body Lean Mass From Baseline up to Week 52 Using DEXA
DEXA is used to assess changes in body composition, including total fat and lean body mass and appendicular skeletal fat and muscle mass. DEXA instruments has a source that generates x-rays split into two energies which measures bone mineral mass and soft tissue from which fat and fat-free mass (or lean body mass) are estimated.
Measured: 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
Percent change in HbA1c was analyzed for participants with Type 2 diabetes mellitus at baseline. Percent change from baseline was calculated as: [post-baseline value minus the baseline value]/baseline value)*100.
Measured: 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
Change in fasting glucose was analyzed for participants with Type 2 diabetes mellitus at baseline. Change from baseline was calculated as the post-baseline value minus the baseline value.
Measured: Baseline up to Week 52
Change in Fasting Insulin From Baseline up to Week 52 for Participants With Type 2 Diabetes Mellitus at Baseline
Change in fasting insulin was analyzed for participants with Type 2 diabetes mellitus at baseline. Change from baseline was calculated as the post-baseline value minus the baseline value.
Measured: 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
HOMA-IR measures insulin resistance based on fasting glucose and insulin measurements: HOMA IR=fasting plasma insulin (micro international units per milliliter [µIU/mL]*fasting plasma glucose (mmol/L)/22.5. A higher number indicates a greater insulin resistance.
Measured: 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
Measured: Baseline up to Week 52
Change in Fasting Insulin From Baseline up to Week 52 in Participants Without Type 2 Diabetes Mellitus at Baseline
Measured: Baseline up to Week 52
Change in HOMA-IR From Baseline up to Week 52 in Participants Without Type 2 Diabetes Mellitus at Baseline
HOMA-IR measures insulin resistance based on fasting glucose and insulin measurements: HOMA IR=fasting plasma insulin (µIU/mL*fasting plasma glucose (mmol/L)/22.5. A higher number indicates a greater insulin resistance.
Measured: Baseline up to Week 52
Change in Blood Pressure (Systolic and Diastolic) From Baseline up to Week 52
Systolic blood pressure is the maximum arterial pressure during contraction of the ventricles of the heart. Diastolic blood pressure is the minimum arterial pressure during relaxation and dilatation of the ventricles of the heart when the ventricles fill with blood.
Measured: Baseline up to Week 52
Change in Heart Rate From Baseline up to Week 52
Heart rate is the number of heart beats per unit of time, usually per minute.
Measured: 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
Total Cholesterol is a measure of the total amount of cholesterol in blood. It includes both LDL cholesterol and HDL cholesterol. LDL cholesterol is often called the "bad" cholesterol because it collects in the walls of blood vessels, raising chances of health problems like a heart attack or stroke. HDL cholesterol is known as the "good" cholesterol because it helps remove other forms of cholesterol from bloodstream. Triglycerides are the most common type of fat in the body.
Measured: Baseline up to Week 52
Percentage of Participants With Prehypertension or Primary Hypertension at Week 52
Hypertension is defined as abnormally high blood pressure.
Measured: Week 52
Percentage of Participants With Dyslipidemia at Week 52
Dyslipidemia is defined as abnormally high cholesterol.
Measured: Week 52
Percentage of Participants by Study Drug Compliance Category During 52 Weeks of Treatment
Treatment compliance is defined as: (Total number of tablets dispensed minus total number of tablets lost or returned)/total number of tablets participant should have taken during the actual treatment. Compliance to study drug was categorized as less than (<) 80%, 80% to 100%, greater than (>) 100% to less than equal to (<=) 120%, and >120%.
Measured: Up to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2017
- Study start28 Sep 2017
- Primary completion3 Apr 2020
- Study completion3 Apr 2020
Why it stopped: Study was terminated as Eisai agreed to voluntarily withdraw Belviq XR from US market.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Eisai Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03338296
- Sponsor's protocol ID
- APD356-A001-403
- Status last verified
- May 2021
- First submitted
- 7 Nov 2017
- Last updated
- 19 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03338296
- Acronym / sponsor ID
- APD356-A001-403
- Conditions
- Obesity
- Keywords
- body mass index, weight loss, adolescents, lifestyle modification
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was terminated as Eisai agreed to voluntarily withdraw Belviq XR from US market.
- Enrolment
- 278 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Sep 2017 (actual)
- Primary completion
- 3 Apr 2020 (actual)
- Study completion
- 3 Apr 2020 (actual)
- First posted
- 9 Nov 2017 (actual)
- Results
- Posted 19 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lorcaserin hydrochloride XR 20 mg QD | Experimental | Drug: lorcaserin hydrochloride XRParticipants will receive lorcaserin hydrochloride extended release (XR) 20 milligrams (mg) once daily (QD) for up to 52 weeks. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo QD for up to 52 weeks. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- 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)
Key exclusion criteria (59 listed)
- 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:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lorcaserin hydrochloride XRAlso: Belviq XR®oral tablet | Drug | Lorcaserin hydrochloride XR 20 mg QD |
| Placebooral tablet | Drug | Placebo |
Primary outcome
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.
23 secondary outcomes
Percentage of Participants Who Achieved at Least a 5 Percent (%) BMI Reduction at Week 52
Time frame: Baseline up to Week 52
Percentage of Participants Who Achieved at Least a 5% BMI Reduction at Week 12
Time frame: Baseline up to Week 12
Percentage of Participants Who Achieved at Least a 10% BMI Reduction at Week 52
Time frame: Baseline up to Week 52
Percent Change in BMI From Baseline up to Week 52
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline up to Week 52
Change in Waist Circumference From Baseline up to Week 52
Time frame: Baseline up to Week 52
Change in Total Body Fat Mass From Baseline up to Week 52 Using Dual-energy X-ray Absorptiometry (DEXA)
Time frame: Baseline up to Week 52
Change in Total Body Lean Mass From Baseline up to Week 52 Using DEXA
Time frame: 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
Time frame: 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
Time frame: Baseline up to Week 52
Change in Fasting Insulin From Baseline up to Week 52 for Participants With Type 2 Diabetes Mellitus at Baseline
Time frame: 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
Time frame: 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
Time frame: Baseline up to Week 52
Change in Fasting Insulin From Baseline up to Week 52 in Participants Without Type 2 Diabetes Mellitus at Baseline
Time frame: Baseline up to Week 52
Change in HOMA-IR From Baseline up to Week 52 in Participants Without Type 2 Diabetes Mellitus at Baseline
Time frame: Baseline up to Week 52
Change in Blood Pressure (Systolic and Diastolic) From Baseline up to Week 52
Time frame: Baseline up to Week 52
Change in Heart Rate From Baseline up to Week 52
Time frame: 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
Time frame: Baseline up to Week 52
Percentage of Participants With Prehypertension or Primary Hypertension at Week 52
Time frame: Week 52
Percentage of Participants With Dyslipidemia at Week 52
Time frame: Week 52
Percentage of Participants by Study Drug Compliance Category During 52 Weeks of Treatment
Time frame: Up to Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing lorcaserin hydrochloride XR in people with Obesity, run by Eisai Inc. at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 59 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Mass Index (BMI) From Baseline up to Week 52 (time frame: Baseline up to Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2021.