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

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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01872182

Enrollment

200

Registered

2013-06-07

Start date

2013-05-31

Completion date

2015-01-31

Last updated

2016-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Obesity Metabolic Syndrome

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.

Interventions

DRUGALS-L1023

daily twice for 12 weeks

DRUGplacebo

daily twice for 12 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

20 Years to 64 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
improvement of metabolic profile	baseline and 12 week
change of insulin resistance	baseline and 12 week
change of BMI	baseline and 12 week

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026