A Dose-ranging, Study of the Safety and Efficacy of Subcutaneous Injections of LIPO-102 Compared With Placebo for the Reduction of Abdominal Subcutaneous Adiposity
Phase 2
Completed
- Conditions
- Weight
- Interventions
- Registration Number
- NCT01180465
- Lead Sponsor
- Neothetics, Inc
- Brief Summary
LIPO-102 is under evaluation for treatment of abdominal adiposity
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 160
Inclusion Criteria
- 18 - 50 years old inclusive
- Localized area of abdominal subcutaneous adiposity of Grade 3 or above on the P-PNS or C-PNS
- BMI < 25kg/m sq
- Stable diet and exercise and body weight
Exclusion Criteria
- Prior treatment of abdominal subcutaneous adipose tissue
- Females within 12 months postpardum
- Known hypersensitivity to the drugs or components
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LIPO-102 High LIPO-102 - LIPO-102, Low LIPO-102 Low - LIPO-102; Placebo LIPO-102, Placebo -
- Primary Outcome Measures
Name Time Method Safety 8 weeks treatment and 1 week follow up physical exam, ECG, vital signs, clinical assessment is injection site, clinical laboratory tests, and adverse events
Change in abdominal circumference 8 weeks abdominal circumference
- Secondary Outcome Measures
Name Time Method Patient and clinician photo numeric scale 8 weeks patient and physician reports of change
Patient global assessment of severity scale 8 weeks patient reports of change in severity
Abdominal subcutaneous adiposity questionnaire 8 weeks Patient reported outcome
photographic assessment 8 weeks abdominal circumference and volume reduction assessment