Evaluation of Safety and Efficacy of Deoxycholic Acid Injection (ATX-101) in the Reduction of Submental Fat

Summary

To evaluate the safety and efficacy of deoxycholic acid injection in the reduction of submental fat (fat below the chin).

Timeline

Start

2010-12

Primary completion

2012-01

Completion

2012-01

Outcome

Met primary endpoint

registry Deoxycholic Acid Injection 1 mg/cm² vs Placebo; p <0.001; Odds Ratio (OR) 4.73 (95% CI 2.70 to 8.28) NCT01305577 ↗

registry Deoxycholic Acid Injection 2 mg/cm² vs Placebo; p <0.001; Odds Ratio (OR) 6.21 (95% CI 3.52 to 10.94) NCT01305577 ↗

registry Deoxycholic Acid Injection 1 mg/cm² vs Placebo; p <0.001; Odds Ratio (OR) 2.99 (95% CI 1.74 to 5.14) NCT01305577 ↗

registry Deoxycholic Acid Injection 2 mg/cm² vs Placebo; p <0.001; Odds Ratio (OR) 5.22 (95% CI 2.99 to 9.11) NCT01305577 ↗

Publications

• McDiarmid J, Ruiz JB, Lee D, Lippert S, Hartisch C, Havlickova B. Results from a pooled analysis of two European, randomized, placebo-controlled, phase 3 studies of ATX-101 for the pharmacologic reduction of excess submental fat. Aesthetic Plast Surg. 2014 Oct;38(5):849-60. doi: 10.1007/s00266-014-0364-9. Epub 2014 Jul 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Deoxycholic Acid	Unknown	1 mg/m2	Other
Subject	Deoxycholic Acid	Unknown	2 mg/m2	Other

Indications

No indication recorded.