Overview

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

Status:
Completed
Trial end date:
2016-08-01
Target enrollment:
0
Participant gender:
All
Summary
The investigation of the long-term safety and maintenance of efficacy of ATX-101 in reduction of submental fat.
Phase:
Phase 3
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Kythera Biopharmaceuticals
Criteria
Inclusion Criteria:

1. Any participant 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. Participants 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.