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

NCT02568319 — Phase 2, Completed, 120 participants, Neothetics, Inc

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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)

Registry	NCT02568319
Status	Completed
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	120 (Estimated)
Sponsor	Neothetics, Inc (Industry)
Conditions	Central Abdominal Bulging
Interventions	LIPO-202, Placebo (Drug)
Dates	start 2015-09-01, primary completion 2015-12-01, first posted 2015-10-05, last updated 2015-12-24
Locations	6 sites in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
LIPO-202	Experimental	Drug: LIPO-202	Experimental arm
Placebo	Placebo comparator	Drug: Placebo	Placebo comparator

LIPO-202 (Drug), also known as Salmeterol
Placebo (Drug), also known as Placebo for LIPO-202

+Outcome measures

Primary outcomes

Safety as measured by physical examination, adverse events, vital signs, and laboratory tests. [9 weeks]: Physical examination, adverse events, vital signs, and laboratory tests.

Secondary outcomes

Change in waist circumference. [9 weeks]

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (6)

Facility	City	Country
Diagnamics, Inc.	Encinitas, California	United States
Ablon Skin Institute and Research Center	Manhattan Beach, California	United States
The Center for Clinical & Cosmetic Research	Aventura, Florida	United States
Skin Research Institute	Coral Gables, Florida	United States
Tennessee Clinical Research Center	Nashville, Tennessee	United States
Charlottesville Medical Research Center	Charlottesville, Virginia	United States

+Investigators

Maria Feldman, Study director, Neothetics, Inc