NCT01546142

Phase 3 Study of Deoxycholic Acid Injection (ATX-101) Versus Placebo for the Reduction of Localized Subcutaneous Fat in the Submental Area

Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 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: 516 (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	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: 2012-03-01
• Primary completion: 2013-05-01
• Completion: 2013-08-01
• First posted: 2012-03-07
• Last updated: 2015-06-15
• Results posted: 2015-06-15

Locations

35 sites across 2 countries: United States, Canada