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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01180465
First Posted: August 12, 2010
Last Update Posted: March 26, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Neothetics, Inc
  Purpose
LIPO-102 is under evaluation for treatment of abdominal adiposity

Condition Intervention Phase
Weight Drug: LIPO-102 Drug: LIPO-102 Low Drug: LIPO-102, Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]
    physical exam, ECG, vital signs, clinical assessment is injection site, clinical laboratory tests, and adverse events

  • Change in abdominal circumference [ Time Frame: 8 weeks ]
    abdominal circumference


Secondary Outcome Measures:
  • photographic assessment [ Time Frame: 8 weeks ]
    abdominal circumference and volume reduction assessment

  • Abdominal subcutaneous adiposity questionnaire [ Time Frame: 8 weeks ]
    Patient reported outcome

  • Patient and clinician photo numeric scale [ Time Frame: 8 weeks ]
    patient and physician reports of change

  • Patient global assessment of severity scale [ Time Frame: 8 weeks ]
    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
Placebo

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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): NCT01180465


Locations
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
First Submitted: August 10, 2010
First Posted: August 12, 2010
Last Update Posted: March 26, 2015
Last Verified: March 2015

Keywords provided by Neothetics, Inc:
Treatment of abdominal adiposity

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