NCT01872182

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2013

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

May 30, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 7, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

October 11, 2016

Status Verified

October 1, 2016

Enrollment Period

1.7 years

First QC Date

May 30, 2013

Last Update Submit

October 10, 2016

Conditions

Abdominal Obesity Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

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

    baseline and 12 week

Secondary Outcomes (3)

  • improvement of metabolic profile

    baseline and 12 week

  • change of insulin resistance

    baseline and 12 week

  • change of BMI

    baseline and 12 week

Study Arms (2)

Test arm

EXPERIMENTAL

ALS-L1023 300mg in two tablets

Drug: ALS-L1023

Comparator arm

PLACEBO COMPARATOR

placebo in two tablets

Drug: placebo

Interventions

ALS-L1023DRUG

daily twice for 12 weeks

Test arm
placeboDRUG

daily twice for 12 weeks

Comparator arm

Eligibility Criteria

Age20 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Alcohol or any drug abuse
  • Any investigational medication during the preceding 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

5 Institutions

Seoul, South Korea

Location

MeSH Terms

Conditions

Abdominal obesity metabolic syndrome

Interventions

ALS-L1023

Study Officials

  • Hye Soon Park, M.D., Ph.D., M.P.H.

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2013

First Posted

June 7, 2013

Study Start

May 1, 2013

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

October 11, 2016

Record last verified: 2016-10

Locations

KR(1)