A Study of the Efficacy of Subcutaneous Phosphatidylcholine and Deoxycholate Injections for Localized Fat Removal

Study Overview
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Brief Summary
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The primary objective of this study is to determine the efficacy of phosphatidylcholine and deoxycholate subcutaneous injections for localized fat removal. Subcutaneous injections of the study drug will be efficacious in decreasing localized fat deposits due to the known fat necrosis effects on fat tissue after study drug tissue incubation.

Detailed Description
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This study is a randomized, double-blind study of 21 subjects. Participants in this study will be healthy, non-obese (BMI <30) subjects over 25 with two localized, symmetrical, and contralateral areas of fat deposition on the abdomen or flanks and on the buttocks or thighs that have proven resistant to diet and exercise. Each participant will be randomized to one of three groups and will receive 4 series of injections two weeks apart. Multiple injections will be placed in the subdermal fat layer from 1-1.5 cm apart depending on the size of the treatment area. Group A will serve as a control and will receive only injections of saline as a placebo. Group B will receive saline injections on one side of the body and receive study drug injections on the contralateral side. Group C will receive only study drug injections. The study sites will include a symmetric, contralateral area of localized fat deposit on both the upper and lower torso. Clinical evaluations will be performed at each visit. Hematologic and ultrasonographic evaluations will be performed at baseline, at the 3rd treatment (Week 4), and at 6 month follow-up. Histologic evaluations will be performed on select individuals at baseline and at the 3rd treatment (Week 4) visit.

Official Title
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A Randomized, Double-Blinded, Study of the Efficacy of Subcutaneous Phosphatidylcholine and Deoxycholate Injections for Localized Fat Removal

Conditions
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Obesity

Intervention / Treatment
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* Drug: Phosphatidylcholine Deoxycholate
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 25 and over BMI of 18.5-29.99 Two localized areas of fat deposition on the upper and lower torso that have failed on self-reported diet and exercise The subject is in good health The subject has the willingness and the ability to understand and provide informed consent Exclusion Criteria: Under 25 years of age Pregnancy or Lactation BMI≥ 30 Subjects with known eating disorders or a history of weight loss/gain of 5 pounds or more within the past 6 months Subjects with hepatrophy, nephopathy, diabetes, hyperthyroidism, neoplasias, AIDS or other immuno-compromised illness, allergies to eggs or soy, poorly controlled hypertension, or autoimmune disease Subjects currently taking blood thinners or who have had chemotherapy or radiation within the last 6 months Subjects with an open, non-healing sore or infection near site of injection Subjects with active eczema or psoriasis Subjects who are unable to understand the protocol or to give informed consent Subjects with mental illness

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: C Phosphatidylcholine Deoxycholate<br>Phosphatidylcholine Deoxycholate Injections. Group C will receive only study drug injections | Drug: Phosphatidylcholine Deoxycholate<br>* Group A will serve as a control and will receive only injections of saline as a placebo. Group B will receive saline injections on one side of the body and receive study drug injections on the contralateral side. Group C will receive only study drug injections<br>* Other names: Lipolight;|
| Placebo Comparator: A Saline<br>Group A will serve as a control and will receive only injections of saline as a placebo. | Drug: Saline<br>* Group A will serve as a control and will receive only injections of saline as a placebo. Group B will receive saline injections on one side of the body and receive study drug injections on the contralateral side. Group C will receive only study drug injections<br>* Other names: salt solution;|
| Active Comparator: B PhosphatidylcholineDeoxycholate/Saline<br>Group B will receive saline injections on one side of the body and receive study drug injections on the contralateral side. | Drug: Phosphatidylcholine Deoxycholate<br>* Group A will serve as a control and will receive only injections of saline as a placebo. Group B will receive saline injections on one side of the body and receive study drug injections on the contralateral side. Group C will receive only study drug injections<br>* Other names: Lipolight;Drug: Saline<br>* Group A will serve as a control and will receive only injections of saline as a placebo. Group B will receive saline injections on one side of the body and receive study drug injections on the contralateral side. Group C will receive only study drug injections<br>* Other names: salt solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of Phosphatidylcholine and Deoxycholate Subcutaneous Injections for Localized Fat Removal. | The primary objective of this study is to determine the efficacy of phosphatidylcholine and deoxycholate subcutaneous injections for localized fat removal. Subcutaneous injections of the study drug will be efficacious in decreasing localized fat deposits | 1 year |