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Completed

NCT Number: NCT02159729

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

This was a long-term follow-up study of participants who completed Kythera-sponsored trials of ATX-101 (06-03, 07-07, 09-15)

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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 2

Primary location

Mei-Heng Tan, Sydney, New South Wales, Australia

Loading trial locations.

About this study

No study medication was 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 subject who successfully completed a Kythera-sponsored clinical trial of ATX-101 (06-03, 07-07, 09-15)
  • Signed informed consent
  • Willingness to comply with schedule and procedures of the study

Exclusion criteria

  • Subjects who have had or are undergoing treatment that may affect the evaluation of the submental area will be excluded

Treatment and study plan

Placebo

Drug

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

ATX-101 (1 mg/cm^2)

Drug

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

ATX-101 (2 mg/cm^2)

Drug

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

ATX-101 (4 mg/cm^2)

Drug

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

Primary outcomes

  1. Percentage of Participants Maintaining CR-SMFRS 1-Grade Response During 5 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: Up to 60 months from long-term follow-up (LTFU) baseline (the last visit in the previous study)

    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 5 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: Up to 60 months from long-term follow-up (LTFU) baseline (the last visit in the previous study)

    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 Composite SMFRS 1-Grade Response During 5 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: Up to 60 months from long-term follow-up (LTFU) baseline (the last visit in the previous study)

    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.

  4. Percentage of Participants Maintaining Composite SMFRS 2-Grade Response During 5 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: Up to 60 months from long-term follow-up (LTFU) baseline (the last visit in the previous study)

    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

Long-term Follow-up Study of Subjects Who Completed Kythera-sponsored Trials of ATX-101 (Sodium Deoxycholate Injection) for the Reduction of Localized Subcutaneous Fat in the Submental Area

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Jun 10, 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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