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Completed

NCT Number: NCT01180465

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

LIPO-102 is under evaluation for treatment of abdominal adiposity

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Key information

Conditions

Weight Body Weight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

San Diego, 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

  • 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

Treatment and study plan

LIPO-102

Drug

LIPO-102 High dose

LIPO-102 Low

Drug

LIPO-102 Low dose

LIPO-102, Placebo

Drug

Placebo

Primary outcomes

  1. 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

  2. Change in abdominal circumference

    Time frame: 8 weeks

    abdominal circumference

Secondary outcomes

  1. photographic assessment

    Time frame: 8 weeks

    abdominal circumference and volume reduction assessment

  2. Abdominal subcutaneous adiposity questionnaire

    Time frame: 8 weeks

    Patient reported outcome

  3. Patient and clinician photo numeric scale

    Time frame: 8 weeks

    patient and physician reports of change

  4. Patient global assessment of severity scale

    Time frame: 8 weeks

    patient reports of change in severity

Sponsors and collaborators

Lead sponsor

Neothetics, Inc

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Aug 12, 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.

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