Assess the Additional Weight Loss Effect of Orlistat Used in Combination With Sibutramine
Obesity
About this trial
This is an interventional treatment trial for Obesity focused on measuring obesity
Eligibility Criteria
MAOInclusion Criteria:
- A patient who gave one's voluntary written consent to participate in this clinical study
- Aged ≥ 18 and < 50 years old
- An obese patient with a body mass index (BMI) ≥ 27 kg/m2
- In case of a women, premenopausal woman
Exclusion Criteria:
- A patient with the weight change ≥ 5% over the past 3 months
- A patient who was receiving a MAO(monoamine oxldase) inhibitor within 1 months of screening
- A patient with an active acute or chronic disease at the participation of the study
- A patient with the malignancy history within the past 5 years
- A patient diagnosed with secondary obesity (Cushing's syndrome, thyroid disease, etc.)
- A patient with a significant cardiovascular disease (coronary vascular disease, congestive heart failure, peripheral arterial obstructive disease, arrhythmia, cerebrovascular disease, etc.), poorly controlled hypertension defined by JNC(Joint National Committee) 7 guidelines, diabetes, severe hepatic/renal disease and CNS(Central Nervous System) disease, drug abuse, psychiatric disorder, positive prostatic hyperplasia concurrent with urinary retention and glaucoma within the past 1 year according to medical records
- A patient falling under the followings from screening test results Hemoglobin < 10g/L or platelets < 100* 103/μL Total bilirubin > 2.0mg/dL Serum GOT(Glutamate oxaloacetate transaminase) or GPT(glutamic pyruvate transaminase) > 120 IU/L Serum creatinine > 1.4mg/dL Serum uric acid > 10mg/dL Thyroid stimulating hormone < 0.1μIU/mL or > 6.5 μIU/mL
- A patient with clear unexplained abnormal findings in chest X-ray, urinalysis, electrocardiogram
- A pregnant women or breastfeeding mother
- A patient participating in another clinical study other than this study
- Other patient who is legally and mentally not appropriate to participate in a clinical study, at the judgment of the investigator
- A person who participated in other clinical study within the past 3 months
Sites / Locations
- GachonGill Medical Center
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Sibutramine + Orlistat
Sibutramine + Orlistat(Placebo)
A lipase inhibitor used for weight loss. Lipase is an enzyme found in the bowel that assists in lipid absorption by the body. Orlistat blocks this enzyme, reducing the amount of fat the body absorbs by about 30%. It is known as a "fat blocker". Because more oily fat is left in the bowel to be excreted, Orlistat can cause an oily anal leakage and fecal incontinence
Sibutramine : one of components included into Diet Pills. This reduces appetite, normalizes amount of cholesterol in blood, and reduces abdominal fat. Orlistat : A lipase inhibitor used for weight loss. Lipase is an enzyme found in the bowel that assists in lipid absorption by the body. Orlistat blocks this enzyme, reducing the amount of fat the body absorbs by about 30%. It is known as a "fat blocker". Because more oily fat is left in the bowel to be excreted, Orlistat can cause an oily anal leakage and fecal incontinence.