Safety and Efficacy Study of LIPO-202 for the Reduction of Central Abdominal Bulging in Obese Subjects

Neothetics

Status and phase: Completed; Phase 2

Conditions: Central Abdominal Bulging

Treatments: Drug: LIPO-202; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02568319

LIPO-202-CL-21

Details and patient eligibility

About

This is a multi-center, randomized, placebo-controlled, double-blind study evaluating the safety and efficacy of LIPO-202 for the reduction of central abdominal bulging in obese subjects.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Healthy male or non-pregnant female subjects
• Capable of providing written consent
• BMI > 30 kg/m2 but < 40 kg/m2
• Stable diet and exercise routine
• At least "Slightly Dissatisfied" with their abdominal bulging on the Abdominal Contour Questionnaire (ACQ)

Exclusion criteria

• BMI > 40 kg/m2
• Have had any treatment of the fat around your abdomen, including surgical procedures (tummy tuck, liposuction), injections for fat loss or treatments with devices to reduce fat in your abdomen.
• Plan on starting a weight loss or exercise program during the study
• Known hypersensitivity to study drugs
• Have any medical condition that might complicate study procedures

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups, including a placebo group

LIPO-202

Experimental group

Description:

Experimental arm

Treatment:

Drug: LIPO-202

Placebo

Placebo Comparator group

Description:

Placebo comparator

Treatment:

Drug: Placebo