NCT02397525

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for phase_2

Geographic Reach
1 country

8 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 25, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Last Updated

August 13, 2015

Status Verified

August 1, 2015

Enrollment Period

1.3 years

First QC Date

March 19, 2015

Last Update Submit

August 11, 2015

Conditions

Central Abdominal Bulging

Outcome Measures

Primary Outcomes (1)

  • Safety: vital signs, physical exams, laboratory tests

    12 months

Study Arms (1)

LIPO-202

EXPERIMENTAL
Drug: LIPO-202

Interventions

LIPO-202DRUG
LIPO-202

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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"

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

AboutSkin Dermatology

Englewood, Colorado, 80113, United States

Location

Dermatology Research Institute, LLC

Coral Gables, Florida, 33146, United States

Location

Gwinnett Clinical Research Center, Inc

Snellville, Georgia, 30078, United States

Location

Lupo Center for Aesthetic and General Dermatology

New Orleans, Louisiana, 70124, United States

Location

Bass Plastic Surgery PLLC

New York, New York, 10065, United States

Location

DermResearch Center of New York

Stony Brook, New York, 11790, United States

Location

Dermatology Clinical Research Center of San Antonio

San Antonio, Texas, 78229, United States

Location

Charlottesville Medical Research

Charlottesville, Virginia, 22911, United States

Location

Study Officials

  • Maria Feldman

    Neothetics, Inc

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2015

First Posted

March 25, 2015

Study Start

March 1, 2015

Primary Completion

June 1, 2016

Last Updated

August 13, 2015

Record last verified: 2015-08

Locations

US(8)