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

Primary Purpose

Abdominal Obesity Metabolic Syndrome

Status
Terminated
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
ALS-L1023
placebo
Sponsored by
Hanmi Pharmaceutical Company Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abdominal Obesity Metabolic Syndrome

Eligibility Criteria

20 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 5 Institutions

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Test arm

Comparator arm

Arm Description

ALS-L1023 300mg in two tablets

placebo in two tablets

Outcomes

Primary Outcome Measures

Percent change from baseline to 12 week in visceral fat area measured by CT

Secondary Outcome Measures

improvement of metabolic profile
change of insulin resistance
change of BMI

Full Information

First Posted
May 30, 2013
Last Updated
October 10, 2016
Sponsor
Hanmi Pharmaceutical Company Limited
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1. Study Identification

Unique Protocol Identification Number
NCT01872182
Brief Title
Efficacy and Safety Study of ALS-L1023 in Patients With Abdominal Obesity of Metabolic Syndrome
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 Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Terminated
Study Start Date
May 2013 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hanmi Pharmaceutical Company Limited

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Obesity Metabolic Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test arm
Arm Type
Experimental
Arm Description
ALS-L1023 300mg in two tablets
Arm Title
Comparator arm
Arm Type
Placebo Comparator
Arm Description
placebo in two tablets
Intervention Type
Drug
Intervention Name(s)
ALS-L1023
Intervention Description
daily twice for 12 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
daily twice for 12 weeks
Primary Outcome Measure Information:
Title
Percent change from baseline to 12 week in visceral fat area measured by CT
Time Frame
baseline and 12 week
Secondary Outcome Measure Information:
Title
improvement of metabolic profile
Time Frame
baseline and 12 week
Title
change of insulin resistance
Time Frame
baseline and 12 week
Title
change of BMI
Time Frame
baseline and 12 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hye Soon Park, M.D., Ph.D., M.P.H.
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
5 Institutions
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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

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