A Dose-ranging, Study of the Safety and Efficacy of Subcutaneous Injections of LIPO-102 Compared With Placebo for the Reduction of Abdominal Subcutaneous Adiposity

This study has been completed.
Information provided by (Responsible Party):
Neothetics, Inc
ClinicalTrials.gov Identifier:
First received: August 10, 2010
Last updated: March 5, 2015
Last verified: March 2015
LIPO-102 is under evaluation for treatment of abdominal adiposity

Condition Intervention Phase
Drug: LIPO-102
Drug: LIPO-102 Low
Drug: LIPO-102, 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 Multi-center, Randomized, Double-masked, Placebo-controlled, Dose-ranging, Study of the Safety and Efficacy of Subcutaneous Injections of LIPO-102 Compared With Placebo for the Reduction of Abdominal Subcutaneous Adiposity

Further study details as provided by Neothetics, Inc:

Primary Outcome Measures:
  • Safety [ Time Frame: 8 weeks treatment and 1 week follow up ] [ Designated as safety issue: No ]
    physical exam, ECG, vital signs, clinical assessment is injection site, clinical laboratory tests, and adverse events

  • Change in abdominal circumference [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    abdominal circumference

Secondary Outcome Measures:
  • photographic assessment [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    abdominal circumference and volume reduction assessment

  • Abdominal subcutaneous adiposity questionnaire [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Patient reported outcome

  • Patient and clinician photo numeric scale [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    patient and physician reports of change

  • Patient global assessment of severity scale [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    patient reports of change in severity

Enrollment: 160
Study Start Date: April 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LIPO-102 High Drug: LIPO-102
LIPO-102 High dose
Experimental: LIPO-102, Low Drug: LIPO-102 Low
LIPO-102 Low dose
Placebo Comparator: LIPO-102; Placebo Drug: LIPO-102, Placebo


Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 18 - 50 years old inclusive
  • Localized area of abdominal subcutaneous adiposity of Grade 3 or above on the P-PNS or C-PNS
  • BMI < 25kg/m sq
  • Stable diet and exercise and body weight

Exclusion Criteria:

  • Prior treatment of abdominal subcutaneous adipose tissue
  • Females within 12 months postpardum
  • Known hypersensitivity to the drugs or components
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01180465

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

Responsible Party: Neothetics, Inc
ClinicalTrials.gov Identifier: NCT01180465     History of Changes
Other Study ID Numbers: LIPO-102-CL-09 
Study First Received: August 10, 2010
Last Updated: March 5, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Neothetics, Inc:
Treatment of abdominal adiposity

ClinicalTrials.gov processed this record on May 02, 2016