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OpenTrials
Completed

NCT Number: NCT01096979

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

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

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Key information

Conditions

Subcutaneous Abdominal Adiposity

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Anaheim, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LIPO-102

Drug

subcutaneous injection

Placebo

Drug

Placebo

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Neothetics, Inc

Industry

Registry information

Official study title

A Double-Masked, Evaluation of the Safety and Efficacy of LIPO-102 for the Reduction of Subcutaneous Abdominal Adiposity

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Mar 31, 2010
Registry last updated
Mar 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.