At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 73 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.
Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of the Safety and Efficacy of ATX-101 (Sodium Deoxycholate for Injection) Given by Three Dosing Paradigms for the Reduction of Localized Subcutaneous Fat in the Submental Area
In Brief
A Phase 2 clinical trial evaluating Deoxycholic Acid Injection and Placebo for Moderate or Severe Submental Fullness. Completed, enrolled 73 participants across 7 sites in 3 countries.
Detailed Summary
Phase 2 trial to evaluate the safety and potential efficacy of one concentration of deoxycholic acid injection, given in three dosing paradigms, compared to placebo for the reduction of submental fat (fat beneath the chin).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsModerate or Severe Submental Fullness
CountriesAustralia, Canada, United Kingdom
Collaborators--
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 2008
Enrollment StartApr 2008
Primary CompletionDec 2008
TodayJul 2026
First PostedFeb 20, 2008
Enrollment StartApr 1, 2008
Primary CompletionDec 1, 2008
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 18.4 years ago
Interventions
Deoxycholic Acid Injectiondrug
Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL.
Placebodrug