Long-term Follow-up Study on Safety and Maintenance of Efficacy of ATX-101

February 4, 2020 updated by: Kythera Biopharmaceuticals

A Multicenter, Double-blind, Nontreatment, Long-term Follow up Study of Subjects Who Completed ATX-101 (Deoxycholic Acid Injection) Clinical Trials ATX-101-11-22 or ATX-101-11-23 for the Reduction of Localized Subcutaneous Fat in the Submental Area

The investigation of the long-term safety and maintenance of efficacy of ATX-101 in reduction of submental fat.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

No study medication is administered in this study.

Study Type

Interventional

Enrollment (Actual)

224

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

  • Canada
      • Vancouver, Canada, V5Z 4E1
        • Shannon Humphrey, MD
      • Vancouver, Canada, V5Z4E1
        • Carruthers Dermatology Centre Inc.
  • United States
    • California
      • San Diego, California, United States, 92121
        • Dermatology Cosmetic Laser Medical Associates of La Jolla
    • Colorado
      • Englewood, Colorado, United States, 80113
        • AboutSkin Dermatology and DermSurgery, PC
    • Florida
      • Coral Gables, Florida, United States, 33146
        • Dermatology Research Institute
      • Coral Gables, Florida, United States, 33146
        • Stephan Baker MD PA
      • Miami, Florida, United States, 33137
        • Baumann Cosmetic and Research Center
      • West Palm Beach, Florida, United States, 33401
        • Kenneth R. Beer, MD, PA
    • Illinois
      • Arlington Hts, Illinois, United States, 60005
        • Altman Dermatology Associates
      • Chicago, Illinois, United States, 60611
        • DeNova Research
      • Naperville, Illinois, United States, 60563
        • DuPage Medical Group, Dermatology Institute
    • Maryland
      • Glendale, Maryland, United States, 20769
        • Callender Center for Clinical Research
      • Rockville, Maryland, United States, 20850
        • Aesthetics, Skin Care, Dermatologic Surgery
    • Tennessee
      • Nashville, Tennessee, United States, 37215
        • Tennessee Clinical Research Center
    • Texas
      • Plano, Texas, United States, 75093
        • Research Across America

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:

  1. Any participant who completed follow-up visits at 12 and 24 weeks after the last dose in one of the two predecessor studies
  2. Willingness to comply with the schedule and procedures of this study.
  3. Signed informed consent form (ICF).

Exclusion Criteria:

1. Participants who have had any treatment or condition (e.g., pregnancy or metabolic disease, which may lead to unstable weight) that may affect assessment of safety or efficacy since enrollment in the predecessor study.

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: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ATX-101
Participants treated with ATX-101 in previous studies ATX-101-11-22 and ATX-101-11-23.
Drug: ATX-101
Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements, recording of adverse events
Placebo Comparator: Placebo
Participants treated with placebo in previous studies ATX-101-11-22 and ATX-101-11-23.
Drug: Placebo
Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements, recording of adverse events

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Maintaining CR-SMFRS 1-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits
Time Frame: From 12 weeks after last treatment (in the predecessor study) to up to 36 months 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).

Non-responders at LTFU baseline in each treatment group (including placebo) were not included in the analysis.
From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Maintaining CR-SMFRS 2-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS 2-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits
Time Frame: From 12 weeks after last treatment (in the predecessor study) to up to 36 months 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).

Non-responders at LTFU baseline in each treatment group (including placebo) were not included in the analysis
From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment.
Percentage of Participants Maintaining PR-SMFRS 1-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were PR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits
Time Frame: From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment

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).

Non-responders at LTFU baseline in each treatment group (including placebo) were not included in the analysis.
From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment
Percentage of Participants Maintaining PR-SMFRS 2-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were PR-SMFRS 2-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits
Time Frame: From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment

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).

Non-responders at LTFU baseline in each treatment group (including placebo) were not included in the analysis.
From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment
Percentage of Participants Maintaining Composite SMFRS 1-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS and PR-SMFRS 1-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits
Time Frame: From 12 weeks after last treatment (in the predecessor study) to up to 36 months 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).

Non-responders at LTFU baseline in each treatment group (including placebo) were not included in the analysis.
From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment
Percentage of Participants Maintaining Composite SMFRS 2-Grade Response During 3 Years of Follow up, i.e. % of Participants Who Were CR-SMFRS and PR-SMFRS 2-Grade Responders at Both Long-term LTFU Baseline and at Subsequent LTFU Visits
Time Frame: From 12 weeks after last treatment (in the predecessor study) to up to 36 months 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).

Non-responders at LTFU baseline in each treatment group (including placebo) were not included in the analysis.
From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment

Collaborators and Investigators

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

Sponsor

Kythera Biopharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

December 1, 2013

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

June 12, 2014

First Submitted That Met QC Criteria

June 13, 2014

First Posted (Estimate)

June 16, 2014

Study Record Updates

Last Update Posted (Actual)

February 17, 2020

Last Update Submitted That Met QC Criteria

February 4, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • ATX-101-13-35

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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