NCT02163902

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 224 (actual)
• Sponsor: Kythera Biopharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

No study medication is administered in this study.

Conditions

• Submental Fat
• Healthy

Interventions

Type	Name	Description
DRUG	ATX-101	Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements, recording of adverse events
DRUG	Placebo	Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements, recording of adverse events

Timeline

• Start date: 2013-12-01
• Primary completion: 2016-01-01
• Completion: 2016-08-01
• First posted: 2014-06-16
• Last updated: 2020-02-17
• Results posted: 2020-02-17

Locations

15 sites across 2 countries: United States, Canada