Completed PHASE3 INTERVENTIONAL 2-arm NCT01542034

Phase 3 Study of Deoxycholic Acid Injection (ATX-101) Versus Placebo for the Reduction of Localized Subcutaneous Fat in the Submental Area (REFINE-1)

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: Feb 29, 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.

A PHASE3 clinical study on Moderate or Severe Submental Fullness, this trial is completed. The trial is conducted by Kythera Biopharmaceuticals and has accumulated 7 data snapshots since 2012. Psychiatric clinical trials are essential for establishing evidence-based treatment standards.

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

Feb 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

Arlington, United States , Atlanta, United States , Beverly Hills, United States , Birmingham, United States , Charlotte, United States , Charlottesville, United States , Chicago, United States , Evansville, United States , Fridley, United States , Glenn Dale, United States and 21 more locations