- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01096979
An Evaluation of the Safety and Efficacy of LIPO-102 for the Reduction of Subcutaneous Abdominal Adiposity
March 5, 2015 updated by: Neothetics, Inc
A Double-Masked, Evaluation of the Safety and Efficacy of LIPO-102 for the Reduction of Subcutaneous Abdominal Adiposity
This is a double-masked evaluation of the safety and efficacy of LIPO-102 for the reduction of subcutaneous abdominal adiposity.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Anaheim, California, United States
-
San Diego, California, United States
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: LIPO-102, High
|
subcutaneous injection
|
Experimental: LIPO-102, Low
|
subcutaneous injection
|
Experimental: Placebo
Pbo
|
Placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety
Time Frame: 8 weeks
|
Vital signs, injection site assessment, clinical laboratory tests (hematology, serum chemistry, lipid panel including FFA, and urine dipstick analysis) and adverse events.
|
8 weeks
|
Reduction in abdominal adiposity
Time Frame: 8 weeks
|
8 weeks
|
|
Waist circumference
Time Frame: 8 weeks
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Photographic assessments
Time Frame: 8 weeks
|
Abdominal volume reductions
|
8 weeks
|
Skin-fold caliper measurements
Time Frame: 8 weeks
|
8 weeks
|
|
Patient and clinician Global Impression of severity survey
Time Frame: 8 weeks
|
8 weeks
|
|
Patient and clinician global impression of change questions
Time Frame: 8 weeks
|
8 weeks
|
|
Abdominal appearance questionnaire
Time Frame: 8 weeks
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2009
Primary Completion (Actual)
March 1, 2010
Study Completion (Actual)
March 1, 2010
Study Registration Dates
First Submitted
October 16, 2009
First Submitted That Met QC Criteria
March 30, 2010
First Posted (Estimate)
March 31, 2010
Study Record Updates
Last Update Posted (Estimate)
March 26, 2015
Last Update Submitted That Met QC Criteria
March 5, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LIPO-102-CL-04
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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