Efficacy and Safety Study of ALS-L1023 in Patients With Abdominal Obesity of Metabolic Syndrome
Phase 3
Terminated
- Conditions
- Abdominal Obesity Metabolic Syndrome
- Interventions
- Drug: placebo
- Registration Number
- NCT01872182
- Lead Sponsor
- Hanmi Pharmaceutical Company Limited
- Brief Summary
The main objective of this study is to evaluate efficacy and safety of ALS-L1023 tablet in patients with abdominal obesity of metabolic syndrome.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
-
Aged between 20 and 64 years(Both genders)
-
more than 2 among components of the metabolic syndrome
- Triglyceride >= 150mg/dL
- HDL-D: Women < 50mg/dL or Men < 40mg/dL
- Hypertension: Systolic blood pressure >= 130mmHg or Diastolic blood pressure >= 85mmHg
- Hyperglycemia: fasting plasma glucose >= 100 mg/dL
-
Informed consent awarding
Exclusion Criteria
- Alcohol or any drug abuse
- Any investigational medication during the preceding 3 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Comparator arm placebo placebo in two tablets Test arm ALS-L1023 ALS-L1023 300mg in two tablets
- Primary Outcome Measures
Name Time Method Percent change from baseline to 12 week in visceral fat area measured by CT baseline and 12 week
- Secondary Outcome Measures
Name Time Method change of BMI baseline and 12 week improvement of metabolic profile baseline and 12 week change of insulin resistance baseline and 12 week
Trial Locations
- Locations (1)
5 Institutions
🇰🇷Seoul, Korea, Republic of