Dose Ranging and Dose Frequency of LIPO-102

February 17, 2015 updated by: Neothetics, Inc

A Dose-Ranging and Dose Frequency Study Evaluating the Safety and Efficacy of LIPO-102 for the Reduction of Abdominal Subcutaneous Adipose Tissue

Dose Ranging and Dose Frequency of LIPO-102

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

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
      • San Diego, California, United States
    • Maryland
      • Baltimore, Maryland, United States

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 to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or non pregnant female
  • Good general health
  • Sufficient abdominal fat for injections
  • Signed informed consent

Exclusion Criteria:

  • Known hypersensitivity to study drugs
  • Treatment with an investigational agent within 30 days of first dose

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Placebo
Drug: Placebo
Placebo
Experimental: LIPO-102
Drug: LIPO-102
Subcutaneous Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety: physical examinations, laboratory tests, AE assessment
Time Frame: 4 weeks treatment and 4 weeks follow up
4 weeks treatment and 4 weeks follow up

Secondary Outcome Measures

Outcome Measure
Time Frame
Efficacy: change in subcutaneous abdominal adipose tissue thickness
Time Frame: 4 weeks treatment and 4 weeks follow up
4 weeks treatment and 4 weeks follow up

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

June 1, 2009

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

June 10, 2009

First Submitted That Met QC Criteria

June 10, 2009

First Posted (Estimate)

June 11, 2009

Study Record Updates

Last Update Posted (Estimate)

March 6, 2015

Last Update Submitted That Met QC Criteria

February 17, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • LIPO-102-CL-03

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 Subcutaneous Adipose Tissue Reduction

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Benin

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe