At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 360 enrolled
Drug / intervention
Deoxycholic acid injection +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of ATX-101 (Sodium Deoxycholate Injection) Versus Placebo for the Reduction of Localized Subcutaneous Fat in the Submental Area
In Brief
A Phase 3 clinical trial evaluating Deoxycholic acid injection and Placebo for Moderate or Severe Submental Fullness. Completed, enrolled 360 participants across 29 sites in 6 countries.
Detailed Summary
To evaluate the safety and efficacy of deoxycholic acid injection in the reduction of submental fat (fat below the chin).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsModerate or Severe Submental Fullness
CountriesBelgium, France, Germany, Italy, Spain, United Kingdom
CollaboratorsBayer
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJan 2011
First PostedFeb 2011
Primary CompletionFeb 2012
TodayJul 2026
First PostedFeb 11, 2011
Enrollment StartJan 1, 2011
Primary CompletionFeb 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 15.4 years ago
Interventions
Deoxycholic acid injectiondrug
Placebodrug
Phosphate buffered saline placebo for injection