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Completed

NCT Number: NCT02163902

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

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

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Key information

Conditions

Submental Fat Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Carruthers Dermatology Centre Inc., Vancouver, Canada

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About this study

No study medication is administered in this study.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

ATX-101

Drug

Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements, recording of adverse events

Placebo

Drug

Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements, recording of adverse events

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Kythera Biopharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jun 16, 2014
Registry last updated
Feb 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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