Obese Adult Male Clinical Trial
Official title:
Phase I Study of RTA 402 in Obese Adults
| Verified date | June 2020 |
| Source | Kyowa Kirin Co., Ltd. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
To investigate changes in body weight and body composition in obese adults after repeated oral administration of RTA 402 once daily for 16 weeks, using placebo as a control.
| Status | Completed |
| Enrollment | 22 |
| Est. completion date | June 18, 2020 |
| Est. primary completion date | May 28, 2020 |
| Accepts healthy volunteers | No |
| Gender | Male |
| Age group | 20 Years to 49 Years |
| Eligibility |
Inclusion Criteria: - Written voluntary informed consent to participate in the study - Male aged = 20 and < 50 years at the time of consent - BMI = 25.0 kg/m2 measured at screening - Waist circumference (umbilical position) = 85 cm measured at screening. - MRI-measured visceral fat area = 100 cm2 measured at screening Exclusion Criteria: - Subjects who have undergone weight control procedures (weight loss medicine, surgical therapy, exercise therapy, bariatric diet, etc.) at a medical institution within 3 months before the screening - Subjects with conditions requiring treatment other than obesity - History of cardiac failure (e.g., a prior diagnosis of congestive cardiac failure defined as NYHA class III or IV or a history of hospitalization for cardiac failure) |
| Country | Name | City | State |
|---|---|---|---|
| Japan | Applied Bio-Pharmatech Kurume Clinical Pharmacology Clinic | Kurume | Fukuoka |
| Lead Sponsor | Collaborator |
|---|---|
| Kyowa Kirin Co., Ltd. |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Changes from baseline in weight measured by Bioelectrical Impedance Analysis | Through study completion, approximately 6 months | ||
| Primary | Changes from baseline in fat mass measured by Dual Energy X-ray Absorption | Through study completion, approximately 6 months | ||
| Primary | Changes from baseline in lean body mass measured by Dual Energy X-ray Absorption | Through study completion, approximately 6 months | ||
| Primary | Changes from baseline in skeletal muscle mass index measured by Dual Energy X-ray Absorption | Through study completion, approximately 6 months | ||
| Primary | Changes from baseline in waist | Through study completion, approximately 6 months | ||
| Primary | Changes from baseline in grip | Through study completion, approximately 6 months | ||
| Primary | Changes from baseline in visceral adipose tissue measured by Magnetic Resonance Imaging | Through study completion, approximately 6 months | ||
| Primary | Changes from baseline in abdominal subcutaneous adipose tissue measured by Magnetic Resonance Imaging | Through study completion, approximately 6 months | ||
| Primary | Changes from baseline in muscle mass measured by Magnetic Resonance Imaging | Through study completion, approximately 6 months | ||
| Primary | Changes from baseline in body fat mass measured by Bioelectrical Impedance Analysis | Through study completion, approximately 6 months | ||
| Primary | Changes from baseline in segmental muscle mass measured by Bioelectrical Impedance Analysis | Through study completion, approximately 6 months | ||
| Primary | Changes from baseline in total body water measured by Bioelectrical Impedance Analysis | Through study completion, approximately 6 months | ||
| Primary | Changes from baseline in extracellular water measured by Bioelectrical Impedance Analysis | Through study completion, approximately 6 months | ||
| Primary | Changes from baseline in basal metabolic rate measured by Bioelectrical Impedance Analysis | Through study completion, approximately 6 months |