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

October 10, 2016 updated by: Hanmi Pharmaceutical Company Limited

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

The main objective of this study is to evaluate efficacy and safety of ALS-L1023 tablet in patients with abdominal obesity of metabolic syndrome.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percent change from baseline to 12 week in visceral fat area measured by CT
Time Frame: baseline and 12 week
baseline and 12 week

Secondary Outcome Measures

Outcome Measure
Time Frame
improvement of metabolic profile
Time Frame: baseline and 12 week
baseline and 12 week
change of insulin resistance
Time Frame: baseline and 12 week
baseline and 12 week
change of BMI
Time Frame: baseline and 12 week
baseline and 12 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hanmi Pharmaceutical Company Limited

Investigators

  • Principal Investigator: Hye Soon Park, M.D., Ph.D., M.P.H., Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

May 30, 2013

First Submitted That Met QC Criteria

June 3, 2013

First Posted (Estimate)

June 7, 2013

Study Record Updates

Last Update Posted (Estimate)

October 11, 2016

Last Update Submitted That Met QC Criteria

October 10, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HM-MELS-301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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