At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 224 enrolled
Drug / intervention
ATX-101 +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.
A Multicenter, Double-blind, Nontreatment, Long-term Follow up Study of Subjects Who Completed ATX-101 (Deoxycholic Acid Injection) Clinical Trials ATX-101-11-22 or ATX-101-11-23 for the Reduction of Localized Subcutaneous Fat in the Submental Area
In Brief
A Phase 3 clinical trial evaluating ATX-101 and Placebo for Submental Fat and Healthy. Completed, enrolled 224 participants across 15 sites in 2 countries.
Detailed Summary
The investigation of the long-term safety and maintenance of efficacy of ATX-101 in reduction of submental fat.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSubmental Fat, Healthy
CountriesCanada, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartDec 2013
First PostedJun 2014
Primary CompletionJan 2016
Study CompletionAug 2016
TodayJul 2026
First PostedJun 16, 2014
Enrollment StartDec 1, 2013
Primary CompletionJan 1, 2016
Study CompletionAug 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 12.0 years ago
Interventions
ATX-101drug
Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements, recording of adverse events
Placebodrug
Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements, recording of adverse events