Conditions: Obesity
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 18
Healthy volunteers: yes

Brief summary:
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:
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.

Arms:
arm 1: Phosphatidylcholine Deoxycholate Injections. Group C will receive only study drug injections arm 2: Group A will serve as a control and will receive only injections of saline as a placebo. arm 3: Group B will receive saline injections on one side of the body and receive study drug injections on the contralateral side.

Interventions: intervention 1: Phosphatidylcholine Deoxycholate intervention 2: Saline
Intervention descriptions: intervention 1: 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 intervention 2: 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

Protocol document: