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Dose Ranging and Dose Frequency of LIPO-102

This study has been completed.
Information provided by (Responsible Party):
Neothetics, Inc Identifier:
First received: June 10, 2009
Last updated: February 17, 2015
Last verified: February 2015
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 Neothetics, 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
Drug: LIPO-102
Subcutaneous Injection
Experimental: Placebo
Drug: Placebo


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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 identifier: NCT00918814

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

Additional Information:
Responsible Party: Neothetics, Inc Identifier: NCT00918814     History of Changes
Other Study ID Numbers: LIPO-102-CL-03 
Study First Received: June 10, 2009
Last Updated: February 17, 2015
Health Authority: United States: Food and Drug Administration processed this record on December 09, 2016