NCT00618722

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

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
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: Kythera Biopharmaceuticals · Industry
• Sex: All
• Age: 25 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Moderate or Severe Submental Fullness

Interventions

Type	Name	Description
DRUG	Deoxycholic Acid Injection
DRUG	Placebo

Timeline

• Start date: 2007-08-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2008-02-20
• Last updated: 2015-07-14
• Results posted: 2015-06-15

Locations

6 sites across 3 countries: Australia, Canada, United Kingdom