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

Phase 2

Completed

• Conditions: Central Abdominal Bulging
• Interventions: Drug: Placebo; Drug: LIPO-202

• Registration Number: NCT02568319
• Lead Sponsor: Neothetics, Inc

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Status Verified: 2015-10
• Study First Submitted: 2015-10-02
• Study First Submitted QC: 2015-10-02
• Study First Posted: 2015-10-05
• Primary Completion: 2015-12
• Last Update Submitted: 2015-12-23
• Last Update Posted: 2015-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo comparator
LIPO-202	LIPO-202	Experimental arm

Primary Outcome Measures

Name	Time	Method
Safety as measured by physical examination, adverse events, vital signs, and laboratory tests.	9 weeks	Physical examination, adverse events, vital signs, and laboratory tests.

Secondary Outcome Measures

Name	Time	Method
Change in waist circumference.	9 weeks

Trial Locations

Locations (6)

Diagnamics, Inc.; 🇺🇸 Encinitas, California, United States

Ablon Skin Institute and Research Center; 🇺🇸 Manhattan Beach, California, United States

Tennessee Clinical Research Center; 🇺🇸 Nashville, Tennessee, United States

The Center for Clinical & Cosmetic Research; 🇺🇸 Aventura, Florida, United States

Skin Research Institute; 🇺🇸 Coral Gables, Florida, United States

Charlottesville Medical Research Center; 🇺🇸 Charlottesville, Virginia, United States