Overview

This trial is active, not recruiting.

Condition central abdominal bulging
Treatment lipo-202
Phase phase 2
Sponsor Neothetics, Inc
Start date March 2015
End date June 2016
Trial size 150 participants
Trial identifier NCT02397525, LIPO-202-CL-22

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
lipo-202

Primary Outcomes

Measure
Safety: vital signs, physical exams, laboratory tests
time frame: 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title An Open-Label Study to Evaluate Retreatment With LIPO-202
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Neothetics, Inc.