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

NCT ID: NCT02568319

Last Updated: 2015-12-24

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Central Abdominal Bulging

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

LIPO-202

Experimental arm

Group Type EXPERIMENTAL

LIPO-202

Intervention Type DRUG

Placebo

Placebo comparator

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

LIPO-202

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Salmeterol Placebo for LIPO-202

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Neothetics, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Maria Feldman

Role: STUDY_DIRECTOR

Neothetics, Inc

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Diagnamics, Inc.

Encinitas, California, United States

Site Status

Ablon Skin Institute and Research Center

Manhattan Beach, California, United States

Site Status

The Center for Clinical & Cosmetic Research

Aventura, Florida, United States

Site Status

Skin Research Institute

Coral Gables, Florida, United States

Site Status

Tennessee Clinical Research Center

Nashville, Tennessee, United States

Site Status

Charlottesville Medical Research Center

Charlottesville, Virginia, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

LIPO-202-CL-21

Identifier Type: -

Identifier Source: org_study_id