At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 55 enrolled
Drug / intervention
ATX-101 +1 moredrug
Likely dose
ATX-101 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.
A Multicenter, Double-blind, Placebo-controlled Safety Study of ATX-101 (Deoxycholic Acid) Injection for the Reduction of Localized Subcutaneous Fat in the Submental Area in Subjects 65 to 75 Years of Age
In Brief
A Phase 3 clinical trial evaluating ATX-101 and Placebo for Moderate to Severe Convexity of Submental Fat and 2 related conditions. Completed, enrolled 55 participants across 6 sites.
Detailed Summary
The objectives of this study are to explore the safety and efficacy of subcutaneous injections of Deoxycholic Acid relative to placebo, in the submental area of participants who are 65 to 75 years old.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartApr 2014
First PostedApr 2014
Primary CompletionAug 2015
Study CompletionSep 2015
TodayJul 2026
First PostedApr 25, 2014
Enrollment StartApr 1, 2014
Primary CompletionAug 1, 2015
Study CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 12.2 years ago
Interventions
ATX-101drug
Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL.
Placebodrug
Phosphate buffered saline placebo for injection