drugset / Trial / NCT01542034

Phase 3 Study of Deoxycholic Acid Injection (ATX-101) Versus Placebo for the Reduction of Localized Subcutaneous Fat in the Submental Area

NCT01542034 ↗

Phase 3 Completed 506 enrolled Kythera Biopharmaceuticals
RandomizedParallel-groupDouble-blindTreatment

Summary

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

Timeline

Start
2012-02
Primary completion
2013-05
Completion
2013-08

Outcome

Met primary endpoint

registry analysis (superiority or other test); Deoxycholic Acid Injection vs Placebo; p <0.001; Risk Ratio (RR) 3.702 (95% CI 2.808 to 4.880); Cochran-Mantel-Haenszel NCT01542034 ↗

registry analysis (superiority or other test); Deoxycholic Acid Injection vs Placebo; p <0.001; Cochran-Mantel-Haenszel NCT01542034 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Deoxycholic Acid Unknown — —

Indications

No indication recorded.