At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 506 enrolled
Drug / intervention
Deoxycholic acid injection +1 moredrug
Likely dose
Deoxycholic acid injection 10 mgfrom 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.
Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 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 506 participants across 36 sites in 2 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
CountriesCanada, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2012
First PostedMar 2012
Primary CompletionMay 2013
Study CompletionAug 2013
TodayJul 2026
First PostedMar 1, 2012
Enrollment StartFeb 1, 2012
Primary CompletionMay 1, 2013
Study CompletionAug 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 14.3 years ago
Interventions
Deoxycholic acid injectiondrug
Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL.
Placebodrug
Phosphate buffered saline placebo for injection