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
  Purpose

LIPO-102 is under evaluation for treatment of abdominal adiposity


Condition Intervention Phase
Weight
Drug: LIPO-102
Drug: LIPO-102 Low
Drug: LIPO-102, Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Lithera, Inc:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 160
Study Start Date: April 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LIPO-102 High Drug: LIPO-102
LIPO-102 High dose
Experimental: LIPO-102, Low Drug: LIPO-102 Low
LIPO-102 Low dose
Placebo Comparator: LIPO-102; Placebo Drug: LIPO-102, Placebo
Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01180465

Locations
United States, California
San Diego, California, United States
United States, New York
New York, New York, United States
Sponsors and Collaborators
Lithera, Inc
  More Information

No publications provided

Responsible Party: Lithera, Inc
ClinicalTrials.gov Identifier: NCT01180465     History of Changes
Other Study ID Numbers: LIPO-102-CL-09, LIPO-102-CL-09
Study First Received: August 10, 2010
Last Updated: September 2, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Lithera, Inc:
Treatment of abdominal adiposity

ClinicalTrials.gov processed this record on October 22, 2014