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

Abdominal Obesity Metabolic Syndrome Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01872182
• Other study ID #: HM-MELS-301
• Status: Terminated
• Phase: Phase 3
• First received: May 30, 2013
• Last updated: October 10, 2016
• Start date: May 2013
• Est. completion date: January 2015

Study information

• Verified date: October 2016
• Source: Hanmi Pharmaceutical Company Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 200
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 64 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abdominal Obesity Metabolic Syndrome
• Metabolic Syndrome X
• Obesity
• Obesity, Abdominal
• Syndrome

Intervention

Drug:
• ALS-L1023
daily twice for 12 weeks
• placebo
daily twice for 12 weeks

Locations

Country	Name	City	State
Korea, Republic of	5 Institutions	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hanmi Pharmaceutical Company Limited

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change from baseline to 12 week in visceral fat area measured by CT		baseline and 12 week	No
Secondary	improvement of metabolic profile		baseline and 12 week	No
Secondary	change of insulin resistance		baseline and 12 week	No
Secondary	change of BMI		baseline and 12 week	No