Safety Study of ATX-101 (Deoxycholic Acid) in Subjects With Mild or Extreme Fullness of Submental Fat

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The objectives of this study are to explore the safety and efficacy of subcutaneous injections of Deoxycholic Acid relative to placebo, in the submental area in patients with mild or extreme fullness of the submental fat and ratings of 1 or 4.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Kythera Biopharmaceuticals
• Treatments: Deoxycholic Acid

Criteria

Inclusion Criteria:

• Male and female subjects, 18 to 65 years old

• Stable Body weight

• Body Mass Index (BMI) of ≤40.0 kg/m^2

• Acceptable volume of submental fat graded by clinician

• Dissatisfaction with the submental area expressed by the subject

• Signed informed consent form (ICF)

• SMF ratings of 1 or 4

Exclusion Criteria:

• No prior intervention for submental fat (SMF) (eg, liposuction, surgery, or lipolytic agents)

• Presence of clinically significant health problems

• History of trauma associated with the chin or neck areas that in the judgment of the investigator may affect evaluation of safety or efficacy of treatment

• Body mass index ≤40 kg/m^2