Health Condition 1: E663- Overweight
Conditions
Sponsors
Leads Clinical Research and Bio Services Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Overweight subjects with BMI between 25-30 kg/m² 2. Subject willing to adhere with their routine diet and exercise regimen throughout the study 3. Females of childbearing age, who agree to use approved birth control methods during the study, and have negative urine pregnancy test (UPT) at screening 4. Subject willing and able to give informed consent and comply with the study procedures
Exclusion criteria
Exclusion criteria: 1. Hypertension patients with systolic blood pressure = 140 mmHg or diastolic blood pressure = 90 mmHg, or those taking diuretics 2. Diabetes patients with fasting blood glucose = 126 mg/dL or random blood glucose = 200 mg/dL, or those taking oral hypoglycemic agents or insulin 3.Subjects with heart, kidney, liver, thyroid, or cerebrovascular diseases 4. Subjects with gallbladder disease, gastrointestinal diseases, gout, or porphyria 5. Subjects with psychiatric disorders such as depression, schizophrenia, alcoholism, or drug addiction 6. Subjects taking obesity treatments (lipase inhibitors, antidepressants, appetite suppressants, contraceptives, steroids, or female hormones) 7. Pregnant or breastfeeding women 8. Subjects who have taken obesity programs or diet supplements within 30 days prior to the study 9. Subjects who are deemed unable to exercise due to severe musculoskeletal disorders 10. Subjects diagnosed with or treated for cancer within the past 5 years 11. Subjects with asthma or other allergic diseases 12. Subjects with a history of surgery within the past 6 months 13. Subjects with a history of drug or alcohol addiction 14. Subjects who participated in another clinical trial within 3 months prior to the study start date 15. Subjects who cannot read or have limited reading ability 16. Subjects deemed unsuitable by the investigator for any other reason start date
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the efficacy of HT099 in comparison with placebo on the reduction in body fat mass using Dual Energy X-ray Absorptiometry (DEXA) in overweight subjectsTimepoint: Baseline and Day 84 | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean Change in anthropometric parameters and body compositionTimepoint: Baseline, Day 28, Day 56, Day 84;Mean Change abdominal fatTimepoint: Baseline and Day 84;Mean Change in BiomarkersTimepoint: Baseline, Day 28, Day 56, Day 84;Overall SafetyTimepoint: Baseline, Day 28, Day 56, Day 84 | — |
Countries
India
Contacts
Public ContactJestin V Thomas
Leads Clinical Research and Bio Services Pvt. Ltd
Outcome results
None listed