Long-term Follow-up Study on Safety and Maintenance of Efficacy of ATX-101

Status:	Active, not recruiting
Conditions:	Healthy Studies
Therapuetic Areas:	Other
Healthy:	No
Age Range:	18 - 65
Updated:	4/21/2016
Start Date:	December 2013
End Date:	May 2016

A Multicenter, Double-blind, Nontreatment, Long Term Follow up Study of Subjects Who Completed ATX-101 (Deoxycholic Acid Injection) Clinical Trials ATX-101-11-22 or ATX-101-11-23 for the Reduction of Localized Subcutaneous Fat in the Submental Area

To investigate the long-term safety and maintenance of efficacy of ATX-101 in reduction of
submental fat.

No study medication is administered in this study.

Inclusion Criteria:

1. Any subject who completed follow-up visits at 12 and 24 weeks after the last dose in
one of the two predecessor studies

2. Willingness to comply with the schedule and procedures of this study.

3. Signed informed consent form (ICF).

Exclusion Criteria:

1. Subjects who have had any treatment or condition (e.g., pregnancy or metabolic disease,
which may lead to unstable weight) that may affect assessment of safety or efficacy since
enrollment in the predecessor study.

We found this trial at

sites

Kenneth R. Beer, MD, PA

West Palm Beach, Florida 33401

from

West Palm Beach, FL