An Evaluation of the Safety and Efficacy of LIPO-102 for the Reduction of Subcutaneous Abdominal Adiposity

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lithera, Inc
ClinicalTrials.gov Identifier:
NCT01096979
First received: October 16, 2009
Last updated: May 13, 2013
Last verified: May 2013
  Purpose

This is a double-masked evaluation of the safety and efficacy of LIPO-102 for the reduction of subcutaneous abdominal adiposity.


Condition Intervention Phase
Subcutaneous Abdominal Adiposity
Drug: LIPO-102
Drug: 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 Double-Masked, Evaluation of the Safety and Efficacy of LIPO-102 for the Reduction of Subcutaneous Abdominal Adiposity

Resource links provided by NLM:


Further study details as provided by Lithera, Inc:

Primary Outcome Measures:
  • Safety [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Waist circumference [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Photographic assessments [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Abdominal volume reductions

  • Skin-fold caliper measurements [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Patient and clinician Global Impression of severity survey [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Patient and clinician global impression of change questions [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Abdominal appearance questionnaire [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: October 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LIPO-102, High
LIPO-102, High
Drug: LIPO-102
subcutaneous injection
Other Name: LIPO-102
Experimental: LIPO-102, Low
LIPO-102, Low
Drug: LIPO-102
subcutaneous injection
Other Name: LIPO-102
Experimental: Placebo
Pbo
Drug: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01096979

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

Additional Information:
No publications provided

Responsible Party: Lithera, Inc
ClinicalTrials.gov Identifier: NCT01096979     History of Changes
Other Study ID Numbers: LIPO-102-CL-04
Study First Received: October 16, 2009
Last Updated: May 13, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Lithera, Inc:
Subcutaneous Adipose Tissue Reduction

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014