Clinical Trial: Efficacy and Safety Study of ALS-L1023 in Patients With Abdominal Obesity of Metabolic Syndrome
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: A Randomized, Double-Blind, Placebo Controlled, Multicenter, 12-week Phase 3 Study to Evaluate Efficacy and Safety of ALS-L1023 Tablet in Patients With Abdominal Obesity of Metabolic Syndrome
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 Summary:
Sponsor: Hanmi Pharmaceutical Company Limited
Current Primary Outcome: Percent change from baseline to 12 week in visceral fat area measured by CT [ Time Frame: baseline and 12 week ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- improvement of metabolic profile [ Time Frame: baseline and 12 week ]
- change of insulin resistance [ Time Frame: baseline and 12 week ]
- change of BMI [ Time Frame: baseline and 12 week ]
Original Secondary Outcome: Same as current
Information By: Hanmi Pharmaceutical Company Limited
Dates:
Date Received: May 30, 2013
Date Started: May 2013
Date Completion:
Last Updated: October 10, 2016
Last Verified: October 2016
