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

Neothetics

Status and phase: Completed; Phase 2

Conditions: Subcutaneous Abdominal Adiposity

Treatments: Drug: Placebo; Drug: LIPO-102

Study type: Interventional

Funder types: Industry

Identifiers

NCT01096979

LIPO-102-CL-04

Details and patient eligibility

About

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

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 3 patient groups

LIPO-102, High

Experimental group

Description:

LIPO-102, High

Treatment:

Drug: LIPO-102

LIPO-102, Low

Experimental group

Description:

LIPO-102, Low

Treatment:

Drug: LIPO-102

Placebo

Experimental group

Description:

Pbo

Treatment:

Drug: Placebo