CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 205 enrolled
Drug / intervention
Placebo +3 moredrug
Likely dose
ATX-101 (1 mg/cm^2)from 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.

Search/NCT02159729
NCT02159729Phase 2Completed

Long-term Follow-up Study of Subjects Who Completed Kythera-sponsored Trials of ATX-101 (Sodium Deoxycholate Injection) for the Reduction of Localized Subcutaneous Fat in the Submental Area

Kythera Biopharmaceuticals·interventional·Posted Jun 10, 2014·Updated Feb 17, 2020

In Brief

A Phase 2 clinical trial evaluating Placebo, ATX-101 (1 mg/cm^2), and 2 other interventions for Submental Fat and Healthy. Completed, enrolled 205 participants across 20 sites in 4 countries.

Detailed Summary

This was a long-term follow-up study of participants who completed Kythera-sponsored trials of ATX-101 (06-03, 07-07, 09-15)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Canada, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 10, 2014
Enrollment StartFeb 1, 2009
Primary CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 6.8 yearsPosted 12.1 years ago

Interventions

Placebodrug

Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements and recording adverse events

ATX-101 (1 mg/cm^2)drug

Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements and recording adverse events

ATX-101 (2 mg/cm^2)drug

Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements and recording adverse events

ATX-101 (4 mg/cm^2)drug

Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements and recording adverse events