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

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

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.

Inclusion Criteria:

• Submental fat (SMF) that was considered undesirable by the subject and graded by the investigator as 2 or 3 using the SMF rating scale
• Good general health
• Signed informed consent

Exclusion Criteria:

• History of any treatment in the neck or chin area
• Loose skin or prominent platysmal bands in the neck or chin area
• Recent treatment with anticoagulants
• Presence of clinically significant health problems