None listed
Conditions
Interventions
Drug : 1. Drugs
- test drug: CMG-OLT-120 (major ingredient: orlistat 120 mg)
- control drug: Xenical capsule 120 mg (major ingredient: orlistat 120 mg)
- placebo: placebo of CMG-OLT-120, placebo
Sponsors
CMG Pharmaceutical
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults over 18 and under 70 2. Obese patients with a BMI of 30 kg/m2 or more or obese patients with 27 kg/m2 or more with other risk factors (e.g., hypertension, diabetes, dyslipidemia) at Screening 3. Those who agree to participate in the diet program during the clinical trial 4. Those who signed an informed consent form voluntarily agreeing to participate in this clinical trial by themselves or a legal representative
Exclusion criteria
Exclusion criteria: 1. Persons who have difficulty in evaluating anthropometric measurement due to anatomical changes such as ablation of a part of the body by surgery 2. Within 1 month prior to screening, those taking Appetite suppressant, Chinese medicine for weight control, Dietary supplement, Insulin, Oral hypoglycemic agent, Beta-blocker, Diuretic, Fish oil supplements, Statin, Oral retinoid, Oral steroid, Thyroid hormone, Cyproheptadine, Phenothiazine, Oral contraceptive, Fiber supplement such as Polyglycoplex, Cyclosporine, GLP-1 receptor agonist, etc. 3. Patients who have had surgery to lose weight: gastroplasty, intestinal resection 4. Persons unable to orally administer capsules or tablets due to disease or surgery 5. Patients with chronic malabsorption syndromes (e.g., chronic gastritis, chronic indigestion, irritable bowel syndrome, etc.) or patients with cholestasis 6. Those who are or need to administer antiretroviral drugs (e.g., atazanavir, ritonavir, tenofovir disoproxil fumarate, etc.) 7. Persons receiving or need to receive stable amiodarone therapy 8. Uncontrolled diabetic patients (HbA1c > 7.5 %) 9. Uncontrolled hypertension patients (SBP = 160 mmHg or DBP = 100 mmHg) 10. Persons whose AST or ALT at Screening is three times or more than the normal upper limit 11. Persons whose Creatinine at Screening is two times or more than the normal upper limit 12. Patients with a history of severe heart disease (NYHA Functional Class III or IV heart failure, myocardial infarction within 6 months, ventricular tachyarrhythmias or unstable angina requiring treatment, etc.) 13. Those who quit smoking within 6 months prior to Screening 14. Those who lose 4 kg or more within 3 months prior to Screening 15. Patients with a history of malignant tumor within 5 years prior to Screening (Registration is possible if the malignant tumor does not recur for more than 5 years. Registration is possible for basal cell carcinoma or for intracutaneous squamous cell carcinoma that does not recur after ablation.) 16. Persons with organic causes of obesity at Screening (e.g., hypothyroidism; TSH level 4.2 mIU/L or more) 17. Those who have a history of alcoholism or drug misuse 18. Pregnant or lactating women 19. Women and men of childbearing age who do not agree to medically accepted contraception during the clinical trial 20. Patients who are scheduled to participate in another clinical trial after enrollment in this study or who have participated in an interventional clinical trial (drug/medical device) within 30 days prior to enrollment in this study 21. Others who are deemed difficult to conduct clinical trials because they cannot understand the purpose, method, etc. of this clinical trial when investigator judges
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight change | — |
Secondary
| Measure | Time frame |
|---|---|
| Weight change;BMI change;Percentage of subjects who have reached weight loss 5 % or more;Waist circumference;Lipid profile change;Adverse event;Laboratory tests, vital signs, and physical examinations;Electrocardiogram (12-lead ECG) test | — |
Countries
Korea, Republic of
Contacts
Public ContactHeon Kang
Kangbuk Samsung Medical Center
Outcome results
None listed