A 16-week, randomized, double-blinded, placebo-controlled study of HT077 and HT048 to evaluate efficacy and safety on health subjects with overweight
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0004271
- Lead Sponsor
- EUMED
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 120
1. Men and women aged =19 and <60 years
2. BMI of 25 to <30 kg/m2
3. Participants who voluntarily decide to participate and sign the informed consent after being provided an explanation of this trial.
1. Participants with a history of hypersensitivity to drugs or food ingredients
2. Participants who have had participated in a commercial weight loss program or clinical trial for obesity within the last three months
3. Participants taking drugs or diet foods that affect their weight within 3 months prior to screening
4. Participants with intentional weight loss of at least 5% within 3 months prior to screening
5. Participants who have undergone surgery, such as gastroplasty and intestinal resection, to lose weight within 6 months prior to screening
6. Endocrine diseases such as hypothyroidism and Cushing's syndrome
7. Participants with severe cerebrovascular disease (cerebral infarction, cerebral hemorrhage, etc.), heart disease (angina pectoris, myocardial infarction, heart failure, arrhythmia in need of treatment), lung disease (chronic obstructive pulmonary disease, etc.) within the last 6 months (However, those who are clinically stable may participate in the trial at the investigator's discretion)
8. Serious dysfunction of the liver (alanine and aspartate aminotransferase levels of 2.5 times the upper limit or normal) or kidney (creatinine > 2.0 mg/dL)
9. Uncontrolled hypertension (blood pressure = 160/100 mmHg)
10. Fasting blood glucose = 126 mg/dL or random blood glucose = 200 mg/dL, or diabetic patients taking oral hypoglycemic agents or insulin
11. Malignant tumor diagnosed within 3 years prior to screening
12. Participants who complain of severe gastrointestinal symptoms such as heartburn and indigestion
13. Participants with a psychologically significant medical history or current disease (schizophrenia, epilepsy, anorexia, bulimia, etc.), or a history of alcohol or the other drug abuse
14. Participants who are determined to be unable to exercise due to musculoskeletal disorders
15. Pregnant or lactating participants, or women of childbearing age who do not agree to use contraception during the trial
16. Participants who are deemed unable to comply with the test requirements or otherwise deemed unsuitable according to the investigator's opinion.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Body fat mass and percent body fat measured by Dual-energy X-ray absorptiometry
- Secondary Outcome Measures
Name Time Method Visceral fat area, subcutaneous fat area, total abdominal fat area, visceral fat/subcutaneous fat area ratio measured by abdominal computed tomography;Body fat mass and percent body fat measured by bioelectrical impedance analysis;Body weight;Body mass index;waist circumference, hip circumference, waist circumference/hip circumference ratio;blood lipid concentration (total cholesterol; triglyceride, high density lipoprotein cholesterol, and low-density lipoprotein cholesterol);Serum leptin and adiponectin concentrations