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Efficacy and Safety Study of ALS-L1023 in Patients With Abdominal Obesity of Metabolic Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01872182
Recruitment Status : Terminated
First Posted : June 7, 2013
Last Update Posted : October 11, 2016
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Abdominal Obesity Metabolic Syndrome Drug: ALS-L1023 Drug: placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : May 2013
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Test arm
ALS-L1023 300mg in two tablets
Drug: ALS-L1023
daily twice for 12 weeks

Placebo Comparator: Comparator arm
placebo in two tablets
Drug: placebo
daily twice for 12 weeks

Primary Outcome Measures :
  1. Percent change from baseline to 12 week in visceral fat area measured by CT [ Time Frame: baseline and 12 week ]

Secondary Outcome Measures :
  1. improvement of metabolic profile [ Time Frame: baseline and 12 week ]
  2. change of insulin resistance [ Time Frame: baseline and 12 week ]
  3. change of BMI [ Time Frame: baseline and 12 week ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   20 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01872182

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Korea, Republic of
5 Institutions
Seoul, Korea, Republic of
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
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Principal Investigator: Hye Soon Park, M.D., Ph.D., M.P.H. Asan Medical Center
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Responsible Party: Hanmi Pharmaceutical Company Limited Identifier: NCT01872182    
Other Study ID Numbers: HM-MELS-301
First Posted: June 7, 2013    Key Record Dates
Last Update Posted: October 11, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
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Metabolic Syndrome
Obesity, Abdominal
Pathologic Processes
Nutrition Disorders
Body Weight
Signs and Symptoms
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases