Safety and Efficacy Study of LIPO-202 for the Reduction of Central Abdominal Bulging in Obese Subjects

December 23, 2015 updated by: Neothetics, Inc

A Phase 2 Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety and Efficacy of LIPO-202 for the Reduction of Central Abdominal Bulging in a Defined Special Population - Obese Subjects (BMI > or Equal to 30 kg/m2)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Encinitas, California, United States, 92024
        • Diagnamics, Inc.
      • Manhattan Beach, California, United States, 90266
        • Ablon Skin Institute and Research Center
    • Florida
      • Aventura, Florida, United States, 33180
        • The Center for Clinical & Cosmetic Research
      • Coral Gables, Florida, United States, 33146
        • Skin Research Institute
    • Tennessee
      • Nashville, Tennessee, United States, 37215
        • Tennessee Clinical Research Center
    • Virginia
      • Charlottesville, Virginia, United States, 22911
        • Charlottesville Medical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy male or non-pregnant female subjects
  • Capable of providing written consent
  • BMI > 30 kg/m2 but < 40 kg/m2
  • Stable diet and exercise routine
  • At least "Slightly Dissatisfied" with their abdominal bulging on the Abdominal Contour Questionnaire (ACQ)

Exclusion Criteria:

  • BMI > 40 kg/m2
  • 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
  • Have any medical condition that might complicate study procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo comparator
Drug: Placebo
Other Names:
  • Placebo for LIPO-202
Experimental: LIPO-202
Experimental arm
Drug: LIPO-202
Other Names:
  • Salmeterol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety as measured by physical examination, adverse events, vital signs, and laboratory tests.
Time Frame: 9 weeks
Physical examination, adverse events, vital signs, and laboratory tests.
9 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in waist circumference.
Time Frame: 9 weeks
9 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neothetics, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

October 2, 2015

First Submitted That Met QC Criteria

October 2, 2015

First Posted (Estimate)

October 5, 2015

Study Record Updates

Last Update Posted (Estimate)

December 24, 2015

Last Update Submitted That Met QC Criteria

December 23, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LIPO-202-CL-21

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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