NCT01032889

Deoxycholic Acid Injection Submental Fat (SMF) Magnetic Resonance Imaging (MRI) and Subject-reported Outcome Measures Study

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 (SMF) Using Magnetic Resonance Imaging (MRI) and a Battery of Clinician- and Subject-reported Measurements.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: Kythera Biopharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Evaluation of the safety, tolerability 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: 2009-12-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2009-12-16
• Last updated: 2015-06-15
• Results posted: 2015-06-15

Locations

10 sites across 1 country: United States