Back to resultsAn Evaluation of the Safety and Efficacy of LIPO-102 for the Reduction of Subcutaneous Abdominal Adiposity
Primary Purpose
Subcutaneous Abdominal Adiposity
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
LIPO-102
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Subcutaneous Abdominal Adiposity focused on measuring Subcutaneous Adipose Tissue Reduction
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
LIPO-102, High
LIPO-102, Low
Placebo
Arm Description
LIPO-102, High
LIPO-102, Low
Pbo
Outcomes
Primary Outcome Measures
Safety
Vital signs, injection site assessment, clinical laboratory tests (hematology, serum chemistry, lipid panel including FFA, and urine dipstick analysis) and adverse events.
Reduction in abdominal adiposity
Waist circumference
Secondary Outcome Measures
Photographic assessments
Abdominal volume reductions
Skin-fold caliper measurements
Patient and clinician Global Impression of severity survey
Patient and clinician global impression of change questions
Abdominal appearance questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01096979
Brief Title
An Evaluation of the Safety and Efficacy of LIPO-102 for the Reduction of Subcutaneous Abdominal Adiposity
Official Title
A Double-Masked, Evaluation of the Safety and Efficacy of LIPO-102 for the Reduction of Subcutaneous Abdominal Adiposity
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neothetics, Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a double-masked evaluation of the safety and efficacy of LIPO-102 for the reduction of subcutaneous abdominal adiposity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subcutaneous Abdominal Adiposity
Keywords
Subcutaneous Adipose Tissue Reduction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LIPO-102, High
Arm Type
Experimental
Arm Description
LIPO-102, High
Arm Title
LIPO-102, Low
Arm Type
Experimental
Arm Description
LIPO-102, Low
Arm Title
Placebo
Arm Type
Experimental
Arm Description
Pbo
Intervention Type
Drug
Intervention Name(s)
LIPO-102
Intervention Description
subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Safety
Description
Vital signs, injection site assessment, clinical laboratory tests (hematology, serum chemistry, lipid panel including FFA, and urine dipstick analysis) and adverse events.
Time Frame
8 weeks
Title
Reduction in abdominal adiposity
Time Frame
8 weeks
Title
Waist circumference
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Photographic assessments
Description
Abdominal volume reductions
Time Frame
8 weeks
Title
Skin-fold caliper measurements
Time Frame
8 weeks
Title
Patient and clinician Global Impression of severity survey
Time Frame
8 weeks
Title
Patient and clinician global impression of change questions
Time Frame
8 weeks
Title
Abdominal appearance questionnaire
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
City
Anaheim
State/Province
California
Country
United States
City
San Diego
State/Province
California
Country
United States
12. IPD Sharing Statement
Learn more about this trial
An Evaluation of the Safety and Efficacy of LIPO-102 for the Reduction of Subcutaneous Abdominal Adiposity
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