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

Neothetics

Status and phase: Completed; Phase 2

Conditions: Weight

Treatments: Drug: LIPO-102; Drug: LIPO-102, Placebo; Drug: LIPO-102 Low

Study type: Interventional

Funder types: Industry

Identifiers

NCT01180465

LIPO-102-CL-09

Details and patient eligibility

About

LIPO-102 is under evaluation for treatment of abdominal adiposity

Enrollment: 160 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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160 participants in 3 patient groups, including a placebo group

LIPO-102 High

Experimental group

Treatment:

Drug: LIPO-102

LIPO-102, Low

Experimental group

Treatment:

Drug: LIPO-102 Low

LIPO-102; Placebo

Placebo Comparator group

Treatment:

Drug: LIPO-102, Placebo