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

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)

Sponsors

Lead Sponsor: Neothetics, Inc

Source Neothetics, Inc
Brief Summary

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.

Overall Status Completed
Start Date September 2015
Primary Completion Date December 2015
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Safety as measured by physical examination, adverse events, vital signs, and laboratory tests. 9 weeks
Secondary Outcome
Measure Time Frame
Change in waist circumference. 9 weeks
Enrollment 120
Condition
Intervention

Intervention Type: Drug

Intervention Name: LIPO-202

Arm Group Label: LIPO-202

Other Name: Salmeterol

Intervention Type: Drug

Intervention Name: Placebo

Arm Group Label: Placebo

Other Name: Placebo for LIPO-202

Eligibility

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Maria Feldman Study Director Neothetics, Inc
Location
Facility:
Diagnamics, Inc. | Encinitas, California, 92024, United States
Ablon Skin Institute and Research Center | Manhattan Beach, California, 90266, United States
The Center for Clinical & Cosmetic Research | Aventura, Florida, 33180, United States
Skin Research Institute | Coral Gables, Florida, 33146, United States
Tennessee Clinical Research Center | Nashville, Tennessee, 37215, United States
Charlottesville Medical Research Center | Charlottesville, Virginia, 22911, United States
Location Countries

United States

Verification Date

October 2015

Responsible Party

Type: Sponsor

Has Expanded Access No
Number Of Arms 2
Arm Group

Label: LIPO-202

Type: Experimental

Description: Experimental arm

Label: Placebo

Type: Placebo Comparator

Description: Placebo comparator

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov