An Evaluation of the Safety and Efficacy of LIPO-102 for the Reduction of Subcutaneous Abdominal Adiposity
- Registration Number
- NCT01096979
- Lead Sponsor
- Neothetics, Inc
- Brief Summary
This is a double-masked evaluation of the safety and efficacy of LIPO-102 for the reduction of subcutaneous abdominal adiposity.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
- Male or non pregnant female
- Good general health
- Sufficient abdominal fat for injections
- Signed informed consent
- BMI greater than or equal to 18 and less than 28 kg/m2
- History of stable weight in past 3 months
Exclusion Criteria
- Known hypersensitivity to study drugs
- Treatment with an investigational agent within 30 days of first dose
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LIPO-102, High LIPO-102 LIPO-102, High LIPO-102, Low LIPO-102 LIPO-102, Low Placebo Placebo Pbo
- Primary Outcome Measures
Name Time Method Reduction in abdominal adiposity 8 weeks Safety 8 weeks Vital signs, injection site assessment, clinical laboratory tests (hematology, serum chemistry, lipid panel including FFA, and urine dipstick analysis) and adverse events.
Waist circumference 8 weeks
- Secondary Outcome Measures
Name Time Method Skin-fold caliper measurements 8 weeks Patient and clinician global impression of change questions 8 weeks Photographic assessments 8 weeks Abdominal volume reductions
Patient and clinician Global Impression of severity survey 8 weeks Abdominal appearance questionnaire 8 weeks