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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Central Abdominal Bulging

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LIPO-202

Group Type EXPERIMENTAL

LIPO-202

Intervention Type DRUG

Interventions

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LIPO-202

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes