Safety Study of ATX-101 (Deoxycholic Acid) in Subjects With Mild or Extreme Fullness of Submental Fat

February 3, 2020 updated by: Kythera Biopharmaceuticals

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 With Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) Grade 1 or CR-SMFRS Grade 4

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 in patients with mild or extreme fullness of the submental fat and ratings of 1 or 4.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

93

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Newport Beach, California, United States
      • San Francisco, California, United States
      • West Hollywood, California, United States, 90069
    • Florida
      • Boca Raton, Florida, United States
      • Coral Gables, Florida, United States, 33146
    • Maryland
      • Glenn Dale, Maryland, United States, 20769
    • Massachusetts
      • Chestnut Hill, Massachusetts, United States, 02467
    • Missouri
      • Saint Louis, Missouri, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female subjects, 18 to 65 years old
  • Stable Body weight
  • Body Mass Index (BMI) of ≤40.0 kg/m^2
  • Acceptable volume of submental fat graded by clinician
  • Dissatisfaction with the submental area expressed by the subject
  • Signed informed consent form (ICF)
  • SMF ratings of 1 or 4

Exclusion Criteria:

  • No prior intervention for submental fat (SMF) (eg, liposuction, surgery, or lipolytic agents)
  • Presence of clinically significant health problems
  • History of trauma associated with the chin or neck areas that in the judgment of the investigator may affect evaluation of safety or efficacy of treatment
  • Body mass index ≤40 kg/m^2

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo - Grade 1
Participants received placebo administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments. Participants With CR SMFRS Grade 1 (mild).
Drug: Placebo
Phosphate buffered saline placebo for injection.
EXPERIMENTAL: ATX-101 deoxycholic acid injection - Grade 1
Participants received deoxycholic acid 2 mg/cm^2 administered in 0.2 mL SC injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments. Participants With Clinician-Reported Submental Fat Rating Scale (CR SMFRS) Grade 1 (mild).
Drug: Deoxycholic Acid
Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL.
Other Names:
  • ATX-101 deoxycholic acid injection
PLACEBO_COMPARATOR: Placebo - Grade 4
Participants received placebo administered in 0.2 mL SC injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments. Participants With CR SMFRS Grade 4 (extreme).
Drug: Placebo
Phosphate buffered saline placebo for injection.
EXPERIMENTAL: ATX-101 deoxycholic acid injection - Grade 4
Participants received deoxycholic acid 2 mg/cm^2 administered in 0.2 mL SC injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments. Participants with CR SMFRS Grade 4 (extreme).
Drug: Deoxycholic Acid
Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL.
Other Names:
  • ATX-101 deoxycholic acid injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With at Least a 1-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on Both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) Assessments
Time Frame: Baseline and up to Week 32 (12 weeks after last treatment)

The investigator evaluated the participant's chin and neck area using the Clinician-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst).

The participant evaluated their chin and neck area using the Patient-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst).
Baseline and up to Week 32 (12 weeks after last treatment)
Percentage of Participants With at Least a 2-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on Both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) Assessments
Time Frame: Baseline and up to Week 32 (12 weeks after last treatment)

The investigator evaluated the participant's chin and neck area using the Clinician-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst).

The participant evaluated their chin and neck area using the Patient-Reported Submental Fat Rating Scale (a 5-point scale) where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst).
Baseline and up to Week 32 (12 weeks after last treatment)
Percentage of Participants With at Least a 1-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)
Time Frame: Baseline and up to Week 32 (12 weeks after last treatment)
The investigator evaluated the participant's chin and neck area using the CR-SMFRS 5-point scale where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst).
Baseline and up to Week 32 (12 weeks after last treatment)
Percentage of Participants With at Least a 2-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)
Time Frame: Baseline and up to Week 32 (12 weeks after last treatment)
The investigator evaluated the participant's chin and neck area using the CR-SMFRS 5-point scale where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst).
Baseline and up to Week 32 (12 weeks after last treatment)
Change From Baseline in Submental Skin Laxity Grade Scale (SMSLG)
Time Frame: Baseline and up to Week 32 (12 weeks after last treatment)
The SMSLG is an integration of three features: skin wrinkling, adherence to underlying neck structures (bone and muscle) and redundancy (horizontal and vertical folds). Each grade (1=none, 2=mild, 3=moderate and 4=severe) defines the maximal allowed limit for skin wrinkling, adherence to underlying structures and redundancy.
Baseline and up to Week 32 (12 weeks after last treatment)
Percentage of Participants With at Least a 1-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on Patient-Reported Submental Fat Rating Scale (PR-SMFRS)
Time Frame: Baseline and up to Week 32 (12 weeks after last treatment)
The participant evaluated their chin and neck area using the PR-SMFRS 5-point scale where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst).
Baseline and up to Week 32 (12 weeks after last treatment)
Percentage of Participants With at Least a 2-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on Patient-Reported Submental Fat Rating Scale (PR-SMFRS)
Time Frame: Baseline and up to Week 32 (12 weeks after last treatment)
The participant evaluated their chin and neck area using the PR-SMFRS 5-point scale where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst).
Baseline and up to Week 32 (12 weeks after last treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kythera Biopharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (ACTUAL)

June 1, 2015

Study Completion (ACTUAL)

June 1, 2015

Study Registration Dates

First Submitted

January 12, 2014

First Submitted That Met QC Criteria

January 12, 2014

First Posted (ESTIMATE)

January 14, 2014

Study Record Updates

Last Update Posted (ACTUAL)

February 17, 2020

Last Update Submitted That Met QC Criteria

February 3, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATX-101-13-27

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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