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

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ClinicalTrials.gov Identifier: NCT01096979
Recruitment Status : Completed
First Posted : March 31, 2010
Last Update Posted : March 26, 2015
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Subcutaneous Abdominal Adiposity Drug: LIPO-102 Drug: Placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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
Study Start Date : October 2009
Primary Completion Date : March 2010
Study Completion Date : March 2010
Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. 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.

  2. Reduction in abdominal adiposity [ Time Frame: 8 weeks ]
  3. Waist circumference [ Time Frame: 8 weeks ]

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

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

Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
ClinicalTrials.gov Identifier: NCT01096979     History of Changes
Other Study ID Numbers: LIPO-102-CL-04
First Posted: March 31, 2010    Key Record Dates
Last Update Posted: March 26, 2015
Last Verified: March 2015

Keywords provided by Neothetics, Inc:
Subcutaneous Adipose Tissue Reduction

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