Dose Ranging Study (RESET)

March 5, 2015 updated by: Neothetics, Inc

A Dose Ranging Study of the Safety and Efficacy of LIPO-202 Healthy Patients With Subcutaneous Fat in the Periumbilical Area

Dose Ranging Study

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

472

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
      • Beverly Hills, California, United States
        • United States, California
      • Encinitas, California, United States
        • United States, California
      • Los Angeles, California, United States
        • United States, California
      • San Diego, California, United States
        • United States, California
      • Santa Ana, California, United States
        • United States, California
    • Florida
      • Aventura, Florida, United States
        • United States, Florida
      • Clearwater, Florida, United States
        • United States, Florida
      • Lake Worth, Florida, United States
        • United States, Florida
      • Miami, Florida, United States
        • United States, Florida
      • Tampa, Florida, United States
        • United States, Florida
    • Illinois
      • Buffalo Grove, Illinois, United States
        • United States, Illinois
      • Chicago, Illinois, United States
        • United States, Illinois
    • New York
      • New York, New York, United States
        • United States, New York
      • Smithtown, New York, United States
        • United States, New York
    • North Carolina
      • Chapel Hill, North Carolina, United States
        • United States, North Carolina
      • Raleigh, North Carolina, United States
        • United States, North Carolina
    • Tennessee
      • Nashville, Tennessee, United States
        • United States, Tennessee
    • Texas
      • Austin, Texas, United States
        • United States, Texas
      • Dallas, Texas, United States
        • United States, Texas
      • Fort Worth, Texas, United States
        • United States, Texas
      • Houston, Texas, United States
        • United States, Texas
      • Plano, Texas, United States
        • United States, Texas

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

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

>18 years of age inclusive Subcutaneous fat in the periumbilical area BMI <30 kg/msq Stable diet and exercise and body weight

Exclusion Criteria:

Prior treatment of subcutaneous fat in the periumbilical area (liposuction, abdominoplasty, etc.) Known hypersensitivity to drugs

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
Experimental: LIPO-202, Low
Drug: salmeterol xinafoate
Drug: Drug: salmeterol xinafoate
Other Names:
  • Salmeterol
  • LIPO-202
Experimental: LIPO-202, Mid
Drug: salmeterol xinafoate
Drug: Drug: salmeterol xinafoate
Other Names:
  • Salmeterol
  • LIPO-202
Experimental: LIPO-202, High
Drug: salmeterol xinafoate
Drug: Drug: salmeterol xinafoate
Other Names:
  • Salmeterol
  • LIPO-202
Experimental: LIPO-202, Placebo
Drug: Placebo
Drug: Drug: Placebo
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: 8 weeks treatment
physical exam, vital signs, clinical assessment of injection, clinical laboratory tests, and adverse events
8 weeks treatment
Change in global clinician abdominal perception scale score (baseline and 9 weeks)
Time Frame: 9 weeks
9 weeks
Change in global patient abdominal perception scale score (baseline and 9 weeks)
Time Frame: 9 weeks
9 weeks
Change in abdominal circumference (baseline and 9 weeks)
Time Frame: 9 weeks
abdominal circumference
9 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Photonumeric abdominal perception scale score (baseline and 9 weeks)
Time Frame: 9 weeks
9 weeks
Change in Patient Reported Outcome for abdominal perception score (baseline and 9 weeks)
Time Frame: 9 weeks
9 weeks

Other Outcome Measures

Outcome Measure
Time Frame
Change in subcutaneous abdominal adipose tissue thickness (baseline and 9 weeks)
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

Investigators

  • Study Director: Murray C Maytom, MBChB, MBA, 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

February 1, 2013

Primary Completion (Actual)

June 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

February 26, 2013

First Submitted That Met QC Criteria

February 28, 2013

First Posted (Estimate)

March 1, 2013

Study Record Updates

Last Update Posted (Estimate)

March 26, 2015

Last Update Submitted That Met QC Criteria

March 5, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LIPO-202-CL-16

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.

Clinical Trials on Periumbilical Subcutaneous Adipose Tissue Reduction

Clinical Trials on Drug: Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritius

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe