Lorcaserin and Behavioral Modification for Overweight and Obesity Management in Chinese Obese Patients

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety and weight loss effect of lorcaserin at the end of the first year of treatment (Week 48) in overweight and Chinese adult obese patients compared to placebo.

Official Title
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Efficacy and Safety of Lorcaserin and Behavioral Modification for Overweight and Obesity Management in Chinese Adult Obese Patients: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study

Conditions
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Obesity

Intervention / Treatment
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* Drug: Lorcaserin 10 mg BID
* Drug: Matching Placebo BID


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females aged from 18 to 65 years (inclusive). Able to walk and preform exercise program required by trial protocol. Body Mass Index (BMI) within the range of 30 to 45 kg/m2 (obese) with or without co-morbid conditions or greater than or equal to 27 and less than 30 kg/m2 (overweight) with at least one treated or untreated comorbid condition (hypertension, dyslipidemia, cardiovascular disease, untreated abnormal glucose metabolism, sleep apnea). For untreated co-morbid conditions, the condition must be considered by the Investigator as clinically stable. Prior to the study, patients should be able to voluntarily participate in this study and sign informed consent form approved by IRB/ICE Exclusion Criteria: Not suitable to participate in the study in the opinion of the Investigator, including an existing physical or mental condition that prevents compliance with the protocol. Patients who had a history of Type 1 diabetes mellitus or confirmed diagnosis of Type 2 diabetes mellitus for more than 6 months. Recent history (within 1 years before entering the study) of major depression, anxiety, or other psychiatric disease requiring treatment with prescription medication (e.g., SSRI's, SNRI's [including buproprion], tricyclics, antipsychotics, lithium). Use of SSRI's and SNRI's (including buproprion) for reasons other than active psychiatric indications (e.g., migraine, weight loss, smoking cessation) must meet a 3-month washout. Total score on the Beck Depression Inventory-II (BDI-II) > 20. Binge Eating Scale score >17. History of epilepsy or other seizure disorder. Has done or anticipate Surgical procedure for the treatment of obesity (i.e., gastric bypass, gastric banding). Anticipation of surgery during the study period that may interfere with completion or compliance with the protocol. Uncontrolled hypertension after certain treatments, defined as systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥ 100 mmHg. History of valve replacement surgery or CABG or other invasive cardiovascular surgical procedure. A diagnostic cardiac catheterization does not exclude. History of Myocardial infarction(MI), Cerebral Vascular Accident(CVA), or transient ischemic attack(TIA). Reversible ischemic neurological deficits (RIND), cardiac arrhythmia requiring medical or surgical treatment within 3 months of screening. Major surgical procedure (intrathoracic, intracranial, intraperitoneal, liposuction) within 6 months of screening History of unstable angina History of congestive heart failure caused by insufficiency or stenosis of any heart valve History of pulmonary artery hypertension Symptomatic untreated congestive heart failure of any etiology (stably treated NYHA class I or II CHF of ischemic or hypertensive etiology is acceptable) History of organ/bone marrow transplantation Abnormal TSH lab value > 1.5x ULN Hyperthyroidism, including abnormal screening lab values with FT4 > ULN and TSH < LLN. Fasting triglycerides > 499 mg/dL(5.64 mmol/L) ,if elevated at Screening, but not on a subsequent re-check, patient will be eligible. Otherwise, patients can't be enrolled. LDL-cholesterol ≥ 190 mg/dL(4.92 mmol/L). HbA1c greater than 9.0% Fasting glucose > 270 mg/dL(11.0 mmol/L) ,if elevated at Screening, but not on a subsequent re-check, patient will be eligible. Otherwise, patients can't be enrolled. Clinically significant abnormal hepatic (e.g., AST or ALT > 2.5x ULN, or total bilirubin > 1.5x ULN) or renal function lab tests (e.g., creatinine > 1.25x ULN) suggestive of hepatic or renal impairment. Positive result of HIV, hepatitis B or hepatitis C screens. Malignancy within 5 years of the screening visit (except basal cell or squamous cell carcinoma with clean surgical margins). Treatment with over-the counter weight loss products or appetite suppressants (including herbal weight loss agents) within 1 month of the screening visit, or with a prescription anti-obesity drug (phentermine, sibutramine, orlistat) or lipid dissolving injections within 3 months. Over 3 days of treatment with oral or parenteral corticosteroids within 2 weeks of the screening visit. Recent history (within 2 years prior to the screening visit) of alcohol or drug abuse. Significant change in smoking habits within 3 months prior to screening. Participated in any clinical study with an investigational drug, biologic, or device within 3 month prior to screening. Significant change in diet or level of physical activity or change in weight of > 5 kg within 3 month prior to screening. Use of liquid weight loss diet within 6 months prior to screening. Disagree to continue to use an accepted method of birth control during and for at least 3 months after last study medication administration.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lorcaserin 10 mg BID<br>Lorcaserin 10 mg tablet each morning and evening | Drug: Lorcaserin 10 mg BID<br>* Lorcaserin 10 mg tablet each morning and evening for a duration of 48 weeks<br>|
| Placebo Comparator: Matching Placebo BID<br>Matching Placebo tablet each morning and evening | Drug: Matching Placebo BID<br>* Matching Placebo tablet each morning and evening for a duration of 48 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5% responders | Proportion (%) of subjects who lose at least 5% of their baseline body weight at week 48 | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight change | Change from baseline in body weight (kilograms) at week 48 | 48 weeks | 
| 10% responders | Proportion (%) of subjects who lose at least 10% of their baseline body weight at week 48 | 48 weeks | 
| circumference and hip circumference change | Change from baseline in waist circumference and hip circumference (centimeters) at week 48 | 48 weeks | 
| Blood Pressure change | Change from baseline in waist systolic/ diastolic blood pressure (mmHg) at week 48 | 48 weeks | 
| Lipids change | Change from baseline in Lipids (total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides) (mmol/L) at week 48 | 48 weeks | 
| CV Risk Markers change | Change from baseline in CV Risk Markers (CRP in μg/L, fibrinogen in g/L) at week 48 | 48 weeks | 
| Glucose and HbA1c change | Change from baseline in fasting glucose (mmol/L) and HbA1c (%) at week 48 | 48 weeks | 
| IWQOL-LITE score change | Change from baseline in IWQOL-LITE score at week 48 | 48 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Overweight or Obesity Management, Behavioral Modification