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

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.