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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.
Information provided by (Responsible Party):
Neothetics, Inc Identifier:
First received: October 16, 2009
Last updated: March 5, 2015
Last verified: March 2015
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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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

Further study details as provided by Neothetics, Inc:

Primary Outcome Measures:
  • Safety [ Time Frame: 8 weeks ]
    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 ]
  • Waist circumference [ Time Frame: 8 weeks ]

Secondary Outcome Measures:
  • Photographic assessments [ Time Frame: 8 weeks ]
    Abdominal volume reductions

  • Skin-fold caliper measurements [ Time Frame: 8 weeks ]
  • Patient and clinician Global Impression of severity survey [ Time Frame: 8 weeks ]
  • Patient and clinician global impression of change questions [ Time Frame: 8 weeks ]
  • Abdominal appearance questionnaire [ Time Frame: 8 weeks ]

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
Experimental: LIPO-102, Low
LIPO-102, Low
Drug: LIPO-102
subcutaneous injection
Experimental: Placebo
Drug: Placebo


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

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
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Please refer to this study by its identifier: NCT01096979

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

Additional Information:
Responsible Party: Neothetics, Inc Identifier: NCT01096979     History of Changes
Other Study ID Numbers: LIPO-102-CL-04
Study First Received: October 16, 2009
Last Updated: March 5, 2015

Keywords provided by Neothetics, Inc:
Subcutaneous Adipose Tissue Reduction

Additional relevant MeSH terms:
Nutrition Disorders
Body Weight
Signs and Symptoms processed this record on May 25, 2017