Deoxycholic Acid Injection Submental Fat (SMF) Magnetic Resonance Imaging (MRI) and Subject-reported Outcome Measures Study

Multicenter, Randomized, Double-blind, Placebo-controlled Study of ATX-101 (Sodium Deoxycholate Injection) Versus Placebo for the Reduction of Localized Subcutaneous Fat in the Submental Area (SMF) Using Magnetic Resonance Imaging (MRI) and a Battery of Clinician- and Subject-reported Measurements.

Evaluation of the safety, tolerability and efficacy of deoxycholic acid injection in the reduction of submental fat (fat below the chin).

Study Overview

• Status: Completed
• Conditions: Moderate or Severe Submental Fullness
• Intervention / Treatment: Drug: Placebo; Drug: Deoxycholic acid injection

• Study Type: Interventional
• Enrollment (Actual): 129
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Investigational Site
  • California
    • Beverly Hills, California, United States, 90210
      • Investigational Site
    • Beverly Hills, California, United States, 90212
      • Investigational Site
    • San Francisco, California, United States, 94115
      • Investigational Site
  • Illinois
    • Naperville, Illinois, United States, 60563
      • Investigational Site
  • Massachusetts
    • Chestnut Hill, Massachusetts, United States, 02467
      • Investigational Site
  • Minnesota
    • Fridley, Minnesota, United States, 55432
      • Investigational Site
  • Missouri
    • St. Louis, Missouri, United States, 63141
      • Investigational Site
  • Nebraska
    • Omaha, Nebraska, United States, 68144
      • Investigational Site
  • Texas
    • Plano, Texas, United States, 75093
      • Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Moderate or severe submental fat
• Dissatisfaction with submental area
• History of stable body weight
• Signed informed consent

Exclusion Criteria:

• Any medical or other condition that would affect subject safety or evaluation of efficacy
• Previous intervention in the submental area

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.	Drug: Placebo; Phosphate buffered saline placebo for injection
Experimental: Deoxycholic acid Injection 1 mg/cm²; Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.	Drug: Deoxycholic acid injection; Other Names: Kybella; ATX-101
Experimental: Deoxycholic acid Injection 2 mg/cm²; Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.	Drug: Deoxycholic acid injection; Other Names: Kybella; ATX-101

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Clinician-Reported Submental Fat Rating Scale Scores	The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme. A negative change from Baseline indicates improvement.	Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)
Change From Baseline in Patient-Reported Submental Fat Scale Rating Scale (PR-SMFRS)	The PR-SMFRS is based on the participant's response to the question "How much fat do you have under your chin right now?" answered on a 5-point ordinal scale (0-4) with 0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat. A negative change from Baseline indicates improvement.	Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)
Change From Baseline in Patient-Reported Submental Fat Impact Scale (PR-SMFIS)	The PR-SMFIS assesses the impact of submental fat on self-perception of 6 emotional and visual characteristics related to the appearance of submental fullness (unhappy, bothered, self-conscious, embarrassed, look older, and look overweight) as evaluated by the participant. Each item is rated on an 11-point numeric scale from 0 to 10. Scores for the 6 items were averaged to generate a PR-SMFIS total scale score ranging from 0 to 10 where 0 is a positive outcome and 10 is a negative outcome. A negative change from Baseline indicates improvement.	Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Submental Fat Volume	Submental fat volume was measured by magnetic resonance imaging (MRI).	Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)
Change From Baseline in Submental Fat Thickness	Submental fat thickness was measured by magnetic resonance imaging (MRI).	Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)

Collaborators and Investigators

• Sponsor: Kythera Biopharmaceuticals
• Investigators: Study Director: Frederick Beddingfield, MD, PhD, Kythera Biopharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: December 10, 2009
• First Submitted That Met QC Criteria: December 14, 2009
• First Posted (Estimate): December 16, 2009

Study Record Updates

• Last Update Posted (Estimate): June 15, 2015
• Last Update Submitted That Met QC Criteria: May 28, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Gastrointestinal Agents; Cholagogues and Choleretics; Deoxycholic Acid
• Other Study ID Numbers: ATX-101-09-15