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

This study is currently recruiting participants.
Verified March 2014 by Hanmi Pharmaceutical Company Limited
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier:
NCT01872182
First received: May 30, 2013
Last updated: March 7, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Abdominal Obesity Metabolic Syndrome
Drug: ALS-L1023
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Hanmi Pharmaceutical Company Limited:

Primary Outcome Measures:
  • Percent change from baseline to 12 week in visceral fat area measured by CT [ Time Frame: baseline and 12 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • improvement of metabolic profile [ Time Frame: baseline and 12 week ] [ Designated as safety issue: No ]
  • change of insulin resistance [ Time Frame: baseline and 12 week ] [ Designated as safety issue: No ]
  • change of BMI [ Time Frame: baseline and 12 week ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: May 2013
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01872182

Contacts
Contact: Inseung Shin inseungshin@hanmi.co.kr

Locations
Korea, Republic of
5 Institutions Recruiting
Seoul, Korea, Republic of
Contact: Hye Soon Park, M.D., Ph.D., M.P.H.       hyesoon@amc.seoul.kr   
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
Investigators
Principal Investigator: Hye Soon Park, M.D., Ph.D., M.P.H. Asan Medical Center
  More Information

No publications provided

Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT01872182     History of Changes
Other Study ID Numbers: HM-MELS-301
Study First Received: May 30, 2013
Last Updated: March 7, 2014
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Metabolic Syndrome X
Obesity
Obesity, Abdominal
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 15, 2014