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

Hanmi Pharmaceutical

Status and phase: Terminated; Phase 3

Conditions: Abdominal Obesity Metabolic Syndrome

Treatments: Drug: ALS-L1023; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01872182

HM-MELS-301

Details and patient eligibility

About

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

Enrollment: 200 patients

Sex: All

Ages: 20 to 64 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups, including a placebo group

Test arm

Experimental group

Description:

ALS-L1023 300mg in two tablets

Treatment:

Drug: ALS-L1023

Comparator arm

Placebo Comparator group

Description:

placebo in two tablets

Treatment:

Drug: placebo