Submental FatPhase 3NCT02163902
Long-term Follow-up Study on Safety and Maintenance of Efficacy of ATX-101
A Phase 3 study testing ATX-101 in people with Submental Fat and Healthy, run by Kythera Biopharmaceuticals at 15 sites in 2 countries.
Trial summary
The investigation of the long-term safety and maintenance of efficacy of ATX-101 in reduction of submental fat. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Submental Fat, Healthy
- What is being tested?
- ATX-101
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 224 participants
- Where
- 15 sitesin 2 countries
- Study dates
- Dec 2013to Aug 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
United States13 sites
Altman Dermatology Associates
Arlington Hts, Illinois, 60005
DeNova Research
Chicago, Illinois, 60611
Dermatology Research Institute
Coral Gables, Florida, 33146
Stephan Baker MD PA
Coral Gables, Florida, 33146
AboutSkin Dermatology and DermSurgery, PC
Englewood, Colorado, 80113
Callender Center for Clinical Research
Glendale, Maryland, 20769
Baumann Cosmetic and Research Center
Miami, Florida, 33137
DuPage Medical Group, Dermatology Institute
Naperville, Illinois, 60563
Tennessee Clinical Research Center
Nashville, Tennessee, 37215
Research Across America
Plano, Texas, 75093
Aesthetics, Skin Care, Dermatologic Surgery
Rockville, Maryland, 20850
Dermatology Cosmetic Laser Medical Associates of La Jolla
San Diego, California, 92121
Kenneth R. Beer, MD, PA
West Palm Beach, Florida, 33401
Canada2 sites
Shannon Humphrey, MD
Vancouver, V5Z 4E1
Carruthers Dermatology Centre Inc.
Vancouver, V5Z4E1
About this study
Official 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
The investigation of the long-term safety and maintenance of efficacy of ATX-101 in reduction of submental fat.
Read the detailed description
No study medication is administered in this study.
- Conditions
- Submental Fat, Healthy
- Being tested
- ATX-101, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATX-101Drug
Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements, recording of adverse events
PlaceboDrug
Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements, recording of adverse events
| Study group | Role | What they receive |
|---|---|---|
| ATX-101 | Experimental | Participants treated with ATX-101 in previous studies ATX-101-11-22 and ATX-101-11-23. Receives: Drug: ATX-101 |
| Placebo | Placebo comparator | Participants treated with placebo in previous studies ATX-101-11-22 and ATX-101-11-23. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment
Secondary outcomes (5)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From 12 weeks after last treatment (in the predecessor study) to up to 36 months after last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2014 (estimated)
- Study startDec 2013
- Primary completionJan 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Submental FatStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kythera Biopharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frederick Beddingfield, III, MD, PhD, Study director, Sponsor GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02163902
- Sponsor's protocol ID
- ATX-101-13-35
- Status last verified
- Jan 2020
- First submitted
- 12 Jun 2014
- Last updated
- 17 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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.
PubMed 33617632
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02163902
- Acronym / sponsor ID
- ATX-101-13-35
- Conditions
- Submental Fat, Healthy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Kythera BiopharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Jan 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 16 Jun 2014 (estimated)
- Results
- Posted 17 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigation of the long-term safety and maintenance of efficacy of ATX-101 in reduction of submental fat.
Detailed description
No study medication is administered in this study.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ATX-101 | Experimental | Drug: ATX-101Participants treated with ATX-101 in previous studies ATX-101-11-22 and ATX-101-11-23. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants treated with placebo in previous studies ATX-101-11-22 and ATX-101-11-23. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ATX-101Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements, recording of adverse events | Drug | ATX-101 |
| PlaceboClinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements, recording of adverse events | Drug | Placebo |
Primary outcome
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.
5 secondary outcomes
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.
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
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
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33617632Humphrey 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederick Beddingfield, III, MD, PhD study director
Sponsor GmbH
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ATX-101 in people with Submental Fat and Healthy, run by Kythera Biopharmaceuticals at 15 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02163902, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2020.