| Eligibility |
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.
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