A phase 3 confrimatory study of ATL-962
- Conditions
- Obesity
- Registration Number
- JPRN-jRCT2080220634
- Lead Sponsor
- Takeda Pharmaceutical Company Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 210
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/d
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Body weight change at the completion of treatment from baseline
- Secondary Outcome Measures
Name Time Method