Dose Ranging and Dose Frequency of LIPO-102

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lithera, Inc
ClinicalTrials.gov Identifier:
NCT00918814
First received: June 10, 2009
Last updated: May 13, 2013
Last verified: May 2013
  Purpose

Dose Ranging and Dose Frequency of LIPO-102


Condition Intervention Phase
Subcutaneous Adipose Tissue Reduction
Drug: LIPO-102
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Dose-Ranging and Dose Frequency Study Evaluating the Safety and Efficacy of LIPO-102 for the Reduction of Abdominal Subcutaneous Adipose Tissue

Further study details as provided by Lithera, Inc:

Primary Outcome Measures:
  • Safety: physical examinations, laboratory tests, AE assessment [ Time Frame: 4 weeks treatment and 4 weeks follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy: change in subcutaneous abdominal adipose tissue thickness [ Time Frame: 4 weeks treatment and 4 weeks follow up ] [ Designated as safety issue: No ]

Enrollment: 54
Study Start Date: June 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LIPO-102
LIPO-102
Drug: LIPO-102
Subcutaneous Injection
Experimental: Placebo
Placebo
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

Exclusion Criteria:

  • Known hypersensitivity to study drugs
  • Treatment with an investigational agent within 30 days of first dose
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00918814

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

Additional Information:
No publications provided

Responsible Party: Lithera, Inc
ClinicalTrials.gov Identifier: NCT00918814     History of Changes
Other Study ID Numbers: LIPO-102-CL-03
Study First Received: June 10, 2009
Last Updated: May 13, 2013
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on July 26, 2014