Phase 1-2 Study of Deoxycholic Acid Injection (ATX-101) for the Reduction of Submental Fat — ATX-101  

Moderate or Severe Submental Fullness Clinical Trial

Official title: Phase 1-2, Multicenter, Randomized, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of ATX-101 (Sodium Deoxycholate for Injection) for the Reduction of Subcutaneous Fat in the Submental Area

Status Completed

Clinical Trial Summary

To evaluate the safety and potential efficacy of deoxycholic acid injection compared to placebo for the reduction of submental fat (fat below the chin).

Clinical Trial Description

The trial included an initial cohort (3 participants in each arm) to evaluate safety followed by expansion to a second, larger cohort if adequate safety was determined in the initial cohort. Data from both cohorts was pooled for analysis. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Moderate or Severe Submental Fullness

• NCT number: NCT00618722
• Study type: Interventional
• Source: Kythera Biopharmaceuticals
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: August 2007
• Completion date: October 2008