None listed
Conditions
Interventions
Drug : Clinical trial subject will randomized to receive BELVIQ(Locaserin 10 mg) or placebo. Subjects will orally self-administer BELVIQ(Locaserin 10 mg) or placebo bid, 2 Tab per day for 48 weeks.
Sponsors
Inje University Seoul Paik Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) South Korean adults aged between 20 and 65 years. 2) Patients with BMI = 35.0 kg/m2 or BMI = 30.0 kg/m2 and suffering from one or more severe co-morbid disorders such as obesity-associated heart disease, hypertension, hyperlipidemia, type 2 diabetes, sleep apnea, and joint disease. 3) Patients who signed the agreement after detailed explanation of the present clinical trial.
Exclusion criteria
Exclusion criteria: 1) Patients using insulin, Glucagon-like peptide-1 agonists (exenatide, liraglutide), or insulin secretagogues (e.g., sulfonylurea). 2) Patients using thyroid hormone drugs or suffering from endocrine disorders such as thyroid dysfunctions, exhibiting thyroid-stimulating hormone (TSH) levels beyond the normal range of 0.1-10.0 uU/ml. 3) Patients with serum liver enzyme levels (ALT, AST) = 3 times the normal upper limit. 4) Patients with serum bilirubin levels = 1.5 times the normal limit. 5) Patients with renal diseases, renal failure, or serum creatinine levels = 1.5 mg/dL for males and = 1.4 mg/dL for females. 6) Patients on drugs that affect weight, such as anti-obesity drugs (absorption inhibitors and appetite suppressants); psychiatric drugs including antidepressants, anticonvulsants, and antiepileptic drugs; contraceptives; steroid preparations; and female hormone drugs, 3 months prior to screening. 7) Patients suffering from cardiovascular disorders (heart failure, angina, myocardial infarction, pulmonary hypertension, severe lung disease, valvular disease, stroke, and congestive heart failure) or those who have received coronary artery bypass graft surgery and angioplasty, 6 months prior to screening. 8) Patients diagnosed with and treated for malignant tumors in the past 5 years. 9) Patients diagnosed with blood diseases such as multiple myeloma, leukemia, and sickle cell anemia. 10) Patients with medical history of neurological or psychiatric disorders such as depression, eating disorder, schizophrenia, alcohol addiction, drug addiction, and epilepsy. 11) Patients using clinical trial drugs or drugs related to heart valve disease (serotonergic drugs and dopaminergic drugs, such as cabergoline) 3 months prior to screening. 12) Patients with bradycardia of less than 50 beats/minute or atrioventricular block (first degree or above, based on electrocardiogram). 13) Patients with anatomical deformation of the penis or priapism, or with anamnesis. 14) Patients on drugs for erectile dysfunction, such as phosphodiesterase5 enzyme inhibitor. 15) Female patients of childbearing age using effective contraceptive methods, specifically, oral contraceptives, during the trial period. 16) Pregnant or lactating women. 17) Patients participating in other clinical trials in the last 3 months. 18) Patients with history of surgical treatment for obesity (e.g., gastric bypass surgery, ileal bypass surgery, and gastric banding), planning to receive surgery, which may interrupt the completion of the present proposal or compliance during the present clinical trial period, or planning to be hospitalized. 19) Patients with severe musculoskeletal disease. 20) Patients with gastrointestinal disorders such as dehydration, diarrhea, and vomiting or suffering from severe gastrointestinal disease. 21) Patients deemed inappropriate to participate in the clinical trial based on the opinion of the clinical trial investigator. 22) Patients who have quit smoking 3 months prior to screening. 23) Patients with uncontrollable hypertension, i.e., systolic blood pressure =160 mmHg or diastolic blood pressure =100 mmHg.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in weight and waist circumference;Change in body mass index(kg/m2) | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood Lipid | — |
Countries
Korea, Republic of
Contacts
Public ContactSeon Oh
Inje University Seoul Paik Hospital
Outcome results
None listed