Evaluating the Safety and Efficacy of LIPO-202 for the Reduction of Central Abdominal Bulging Due to Subcutaneous Fat

Phase 3

Completed

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

• Registration Number: NCT02397499
• Lead Sponsor: Neothetics, Inc

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-19
• Study First Submitted QC: 2015-03-24
• Study First Posted: 2015-03-25
• Study Start: 2015-04
• Primary Completion: 2015-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-06
• Last Update Posted: 2016-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

• Healthy male or non-pregnant female subjects
• Capable of providing written consent.
• BMI < 30 kg/m2
• Stable diet and exercise routine
• Central abdominal bulging that is evaluated by the clinician 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.
• Known hypersensitivity to study drugs

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.	8 weeks	Physical examination, adverse events, vital signs, and laboratory tests.
Change in the clinician reported photonumeric score	8 weeks post the start of treatment
Change in the patient reported global abdominal perception score	8 weeks post the start of treatment

Secondary Outcome Measures

Name	Time	Method
Change in waist circumference	8 weeks post the start of treatment

Trial Locations

Locations (31)

WG Clinical Research; 🇺🇸 Tucson, Arizona, United States

Burke Pharmaceutical Research; 🇺🇸 Hot Springs, Arkansas, United States

Clinical Testing Center of Beverly Hills; 🇺🇸 Beverly Hills, California, United States

Center for Dermatology Cosmetic and Laser Surgery; 🇺🇸 Fremont, California, United States

Dermatology/Cosmetic Laser Associates of La Jolla, Inc; 🇺🇸 San Diego, California, United States

University Clinical Trials, Inc.; 🇺🇸 San Diego, California, United States

Clinical Science Institute; 🇺🇸 Santa Monica, California, United States

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

Skin Care Research, Inc.; 🇺🇸 Boca Raton, Florida, United States

Clinical Research of West Florida, Inc.; 🇺🇸 Clearwater, Florida, United States

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