NCT01305577

Evaluation of Safety and Efficacy of Deoxycholic Acid Injection (ATX-101) in the Reduction of Submental Fat

Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of ATX-101 (Sodium Deoxycholate Injection) Versus Placebo for the Reduction of Localized Subcutaneous Fat in the Submental Area

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 363 (actual)
• Sponsor: Kythera Biopharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

To evaluate the safety and efficacy of deoxycholic acid injection in the reduction of submental fat (fat below the chin).

Conditions

• Moderate or Severe Submental Fullness

Interventions

Type	Name	Description
DRUG	Deoxycholic acid injection
DRUG	Placebo	Phosphate buffered saline placebo for injection

Timeline

• Start date: 2010-12-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2011-02-28
• Last updated: 2015-07-14
• Results posted: 2015-06-15

Locations

30 sites across 5 countries: Belgium, France, Germany, Spain, United Kingdom