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

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: Healthy; Submental Fat
• Intervention / Treatment: Drug: ATX-101; Drug: Placebo

Detailed Description

No study medication is administered in this study.

• Study Type: Interventional
• Enrollment (Actual): 224
• Phase: Phase 3

Contacts and Locations

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

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	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	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	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	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	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

• Sponsor: Kythera Biopharmaceuticals

Publications and helpful links

General Publications

• Humphrey S, Cohen JL, Bhatia AC, Green LJ, Green JB, Bowen B. Improvements in Submental Contour up to 3 Years After ATX-101: Efficacy and Safety Follow-Up of the Phase 3 REFINE Trials. Aesthet Surg J. 2021 Oct 15;41(11):NP1532-NP1539. doi: 10.1093/asj/sjab100.

Study record dates

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