NCT02123134

Safety Study of Deoxycholic Acid for the Reduction of Localized Subcutaneous Fat in the Submental Area in Subjects 65 to 75 Years of Age

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Kythera Biopharmaceuticals · Industry
• Sex: All
• Age: 65 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Moderate to Severe Convexity of Submental Fat
• Safety
• Efficacy

Interventions

Type	Name	Description
DRUG	ATX-101	Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL.
DRUG	Placebo	Phosphate buffered saline placebo for injection

Timeline

• Start date: 2014-04-01
• Primary completion: 2015-08-01
• Completion: 2015-09-01
• First posted: 2014-04-25
• Last updated: 2020-02-17
• Results posted: 2020-02-17

Locations

6 sites across 1 country: United States