An Open-Label Study to Evaluate Retreatment With LIPO-202

Phase 2

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

• Registration Number: NCT02397525
• Lead Sponsor: Neothetics, Inc

Brief Summary

Evaluate the safety of three 8-week courses of treatment with LIPO-202 in non-obese patients who have central abdominal bulging. Efficacy measurements will also be collected.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-19
• Study First Submitted QC: 2015-03-19
• Study First Posted: 2015-03-25
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-11
• Last Update Posted: 2015-08-13
• Primary Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Provided consent
• Healthy male or non-pregnant female subjects
• BMI < 30 kg/m2
• Stable diet and exercise routine
• Central abdominal bulging that is at least "Slight Bulge, Not Flat"

Exclusion Criteria

• 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.
• Be a woman who is pregnant, breast feeding, have had a baby within 6 months and/or not using appropriate birth control.
• Known hypersensitivity to study drugs
• Prior or current enrollment in any Neothetics (formerly Lithera) study involving LIPO-102 or LIPO-202

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LIPO-202	LIPO-202	-

Primary Outcome Measures

Name	Time	Method
Safety: vital signs, physical exams, laboratory tests	12 months

Trial Locations

Locations (8)

AboutSkin Dermatology; 🇺🇸 Englewood, Colorado, United States

DermResearch Center of New York; 🇺🇸 Stony Brook, New York, United States

Dermatology Clinical Research Center of San Antonio; 🇺🇸 San Antonio, Texas, United States

Bass Plastic Surgery PLLC; 🇺🇸 New York, New York, United States

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

Dermatology Research Institute, LLC; 🇺🇸 Coral Gables, Florida, United States

Gwinnett Clinical Research Center, Inc; 🇺🇸 Snellville, Georgia, United States

Lupo Center for Aesthetic and General Dermatology; 🇺🇸 New Orleans, Louisiana, United States