A Phase III Study to Evaluate the Efficacy and Safety of CMG-OLT-120 in Obese Patients
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0004540
- Lead Sponsor
- CMG Pharmaceutical
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 180
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
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Weight change
- Secondary Outcome Measures
Name Time Method 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