Multicenter, stratified, randomized, double-blind, parallel-group study
3
Key Criteria for inclusion:
The subject whose BMI is not less than 25 at the start and the end of the run-in period.
The subject whose visceral fat area is not less than 100 cm2 at 8 weeks after the start of the run-in period(-4 Week).
The subject who is diagnosed as type 2 diabetes mellitus and the HbA1C values are >= 6.5% and < 10.0% at the start of the run-in period.
The subject who diagnosed as dyslipidemia and meet one of the following criteria for the fasting plasma lipid profile at the start of the run-in period:
Hyper-LDL cholesterolemia:LDL cholesterol >= 140 mg/dL
Hypo-HDL cholesterolemia:HDL cholesterol < 40 mg/dL
Hypertriglyceridemia:Triglyceride >= 150 mg/dL
Key Criteria for exclusion:
The subject who have received any anti-obesity drugs (Mazindol and/or prescribed herb medicines which are indicated as an anti-obesity drug) within 4 weeks prior to the start of the run-in period
20age old over
No limit
Both
Obesity
investigational material(s)
Generic name etc : ATL-962
INN of investigational material :
Therapeutic category code : 399 Agents affecting metabolism, n.e.c.
Dosage and Administration for Investigational material : Two ATL-962 60mg tablets will be orally administered three times daily immediately after meal
control material(s)
Generic name etc : Placebo
INN of investigational material :
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : Two placebo tablets will be orally administered three times daily immediately after meal
Body weight change at the completion of treatment from baseline
