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

This study is currently recruiting participants. (see Contacts and Locations)
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
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, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on July 31, 2014