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.
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
14
sites
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