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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
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: 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
Body Weight
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms

ClinicalTrials.gov processed this record on November 24, 2014