Completed PHASE3 INTERVENTIONAL 2-arm NCT01546142

Phase 3 Study of Deoxycholic Acid Injection (ATX-101) Versus Placebo for the Reduction of Localized Subcutaneous Fat in the Submental Area

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

Sponsor: Kythera Biopharmaceuticals

Conditions Moderate or Severe Submental Fullness

Interventions Deoxycholic acid injection Placebo

Updated 7 times since 2017 Last updated: May 28, 2015 Started: Mar 31, 2012 Primary completion: May 31, 2013 Completion: Aug 31, 2013

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT01546142, this PHASE3 trial focuses on Moderate or Severe Submental Fullness and remains completed. Sponsored by Kythera Biopharmaceuticals, it has been updated 7 times since 2012, reflecting limited change activity. Mental health research at this phase helps define safety and dosing parameters for future study.

Status Flow

Change History

7 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE3
Sep 2024 — Sep 2025 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jan 2021 — Jul 2024 [monthly]

Completed PHASE3
Jun 2018 — Jan 2021 [monthly]

Completed PHASE3

▶ Show 2 earlier versions

Feb 2017 — Jun 2018 [monthly]

Completed PHASE3
Jan 2017 — Feb 2017 [monthly]

Completed PHASE3

First recorded

Mar 2012

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Kythera Biopharmaceuticals

Data source: Kythera Biopharmaceuticals

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Austin, United States , Beverly Hills, United States , Calgary, Canada , Carmel, United States , Charlotte, United States , Charlottesville, United States , Chicago, United States , Cincinnatti, United States , Clinton Township, United States , Coral Gables, United States and 24 more locations