NCT02035267

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

A Multicenter, Double-blind, Placebo-controlled Safety Study of ATX-101 (Deoxycholic Acid) Injection for the Reduction of Localized Subcutaneous Fat in the Submental Area in Subjects With Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) Grade 1 or CR-SMFRS Grade 4

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: Kythera Biopharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Moderate to Severe Convexity of Submental Fat
• Safety
• Efficacy

Interventions

Type	Name	Description
DRUG	Deoxycholic Acid	Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL.
DRUG	Placebo	Phosphate buffered saline placebo for injection.

Timeline

• Start date: 2014-01-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2014-01-14
• Last updated: 2020-02-17
• Results posted: 2020-02-17

Locations

8 sites across 1 country: United States