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

Completed · Phase 3 · Has a placebo group

Conditions studied: Moderate to Severe Convexity of Submental Fat, Safety, Efficacy

In brief

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.

Key facts

Study ID: NCT02035267
Run by: Kythera Biopharmaceuticals
People needed: 93
Starts: 2014-01-01
Expected to finish: 2015-06-01
Last updated by the study team: 2020-02-17

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Study site — Newport Beach, California, United States
Study site — San Francisco, California, United States
Study site — West Hollywood, California, United States
Study site — Boca Raton, Florida, United States
Study site — Coral Gables, Florida, United States
Study site — Glenn Dale, Maryland, United States
Study site — Chestnut Hill, Massachusetts, United States
Study site — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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