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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.
Sponsor:
Information provided by (Responsible Party):
Neothetics, Inc
ClinicalTrials.gov Identifier:
NCT01096979
First received: October 16, 2009
Last updated: March 5, 2015
Last verified: March 2015
  Purpose
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
Pbo
Drug: Placebo
Placebo

  Eligibility

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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01096979

Locations
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
Study First Received: October 16, 2009
Last Updated: March 5, 2015

Keywords provided by Neothetics, Inc:
Subcutaneous Adipose Tissue Reduction

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

ClinicalTrials.gov processed this record on July 24, 2017