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

• Sponsor: Hanmi Pharmaceutical Company Limited (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01872182
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2
• Duration (Months): 20
• Patients Per Site Per Month: 10

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Abdominal Obesity Metabolic Syndrome	Drug: ALS-L1023; Drug: placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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 Start Date: May 1, 2013
• Actual Primary Completion Date: Jan 1, 2015
• Actual Study Completion Date: Jan 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Percent change from baseline to 12 week in visceral fat area measured by CT [baseline and 12 week]

Secondary Outcome Measures

1. improvement of metabolic profile [baseline and 12 week]

2. change of insulin resistance [baseline and 12 week]

3. change of BMI [baseline and 12 week]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	5 Institutions	Seoul		Korea, Republic of

Sponsors and Collaborators

• Hanmi Pharmaceutical Company Limited

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hanmi Pharmaceutical Company Limited
• ClinicalTrials.gov Identifier: NCT01872182
• Other Study ID Numbers: HM-MELS-301
• First Posted: Jun 7, 2013
• Last Update Posted: Oct 11, 2016
• Last Verified: Oct 1, 2016

• Additional relevant MeSH terms: Obesity; Metabolic Syndrome; Obesity, Abdominal; Syndrome

Study Results

No Results Posted as of Oct 11, 2016