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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lithera, Inc
ClinicalTrials.gov Identifier:
NCT01180465
First received: August 10, 2010
Last updated: September 2, 2011
Last verified: September 2011

August 10, 2010
September 2, 2011
April 2010
September 2010   (final data collection date for primary outcome measure)
  • Safety [ Time Frame: 8 weeks treatment and 1 week follow up ] [ Designated as safety issue: No ]
    physical exam, ECG, vital signs, clinical assessment is injection site, clinical laboratory tests, and adverse events
  • Change in abdominal circumference [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    abdominal circumference
Same as current
Complete list of historical versions of study NCT01180465 on ClinicalTrials.gov Archive Site
  • photographic assessment [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    abdominal circumference and volume reduction assessment
  • Abdominal subcutaneous adiposity questionnaire [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Patient reported outcome
  • Patient and clinician photo numeric scale [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    patient and physician reports of change
  • Patient global assessment of severity scale [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    patient reports of change in severity
Same as current
Not Provided
Not Provided
 
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
A Multi-center, Randomized, Double-masked, Placebo-controlled, Dose-ranging, Study of the Safety and Efficacy of Subcutaneous Injections of LIPO-102 Compared With Placebo for the Reduction of Abdominal Subcutaneous Adiposity

LIPO-102 is under evaluation for treatment of abdominal adiposity

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Weight
  • Drug: LIPO-102
    LIPO-102 High dose
  • Drug: LIPO-102 Low
    LIPO-102 Low dose
  • Drug: LIPO-102, Placebo
    Placebo
  • Experimental: LIPO-102 High
    Intervention: Drug: LIPO-102
  • Experimental: LIPO-102, Low
    Intervention: Drug: LIPO-102 Low
  • Placebo Comparator: LIPO-102; Placebo
    Intervention: Drug: LIPO-102, Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
160
September 2010
September 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01180465
LIPO-102-CL-09, LIPO-102-CL-09
No
Lithera, Inc
Lithera, Inc
Not Provided
Not Provided
Lithera, Inc
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP