Submental FatPhase 2NCT02159729

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

A Phase 2 study testing ATX-101 (1 mg/cm^2), ATX-101 (2 mg/cm^2) and ATX-101 (4 mg/cm^2) in people with Submental Fat and Healthy, run by Kythera Biopharmaceuticals at 20 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This was a long-term follow-up study of participants who completed Kythera-sponsored trials of ATX-101 (06-03, 07-07, 09-15) 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 (1 mg/cm^2), ATX-101 (2 mg/cm^2) and ATX-101 (4 mg/cm^2)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 205 participants
Where: 20 sitesin 4 countries
Study dates: Feb 2009to Dec 2015
Phase: Phase 2
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 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

Who cannot join

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

Trial locations and contacts

20 sites in 4 countries.

Country

City, postcode or hospital

20 sites in 4 countries

United States10 sites

Clinical Testing Center Beverly Hills
Beverly Hills, California, 90210
Mokusiga, Inc
Beverly Hills, California, 90212
Total Skin & Beauty Dermatology Center
Birmingham, Alabama, 35205
Skin Care Physicians
Chestnut Hill, Massachusetts, 02467
Minnesota Clinical Study Center
Fridley, Minnesota, 55432
Dermatology Institute of DuPage Medical Group in Naperville
Naperville, Illinois, 60563
Skin Specialists, PC
Omaha, Nebraska, 68144
Research Across America
Plano, Texas, 75093
Plastic & Reconstructive Surgery
San Francisco, California, 94115
Body Aesthetic Research Center
St Louis, Missouri, 63141

Other trials in United States

Australia4 sites

Skin Centre, AHC House
Benowa, Queensland, 4217
Southeast Dermatology Belmont Specialist Centre
Carina Heights, Queensland, 4152
T/AS Dermatology Institute of Victoria
South Yarra, Victoria, 3141
Mei-Heng Tan
Sydney, New South Wales, 2000

Other trials in Australia

Canada4 sites

Niagara Falls Dermatology & Skin Care
Niagara Falls, Ontario, L2E 7H1
Institute of Cosmetic & Laser Surgery
Oakville, Ontario, L6J 7W5
Toronto Cosmetic Skin Surgery Centre
Toronto, Ontario, M4V 1R1
Cosmetic Dermatology on Bloor
Toronto, Ontario, M5S 3B4

Other trials in Canada

United Kingdom2 sites

Cranley Clinic, Harcout House
London, W1G OPN
The Dermatology Centre
Salford, Manchester, M6 8HD

Other trials in United Kingdom

About this study

Official 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

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

Read the detailed description

No study medication was administered in this study.

Conditions: Submental Fat, Healthy
Being tested: Placebo, ATX-101 (1 mg/cm^2), ATX-101 (2 mg/cm^2), ATX-101 (4 mg/cm^2)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboDrug
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

Study groups in NCT02159729
Study group	Role	What they receive
Placebo	Placebo comparator	Participants treated with placebo in previous ATX-101 studies Receives: Drug: Placebo
ATX-101 (1 mg/cm^2)	Experimental	Participants treated with ATX-101 (1 mg/cm^2) in previous phase 2 studies Receives: Drug: ATX-101 (1 mg/cm^2)
ATX-101 (2 mg/cm^2)	Experimental	Participants treated with ATX-101 (2 mg/cm^2) in previous phase 2 studies Receives: Drug: ATX-101 (2 mg/cm^2)
ATX-101 (4 mg/cm^2)	Experimental	Participants treated with ATX-101 (4 mg/cm^2) in previous phase 2 studies Receives: Drug: ATX-101 (4 mg/cm^2)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2009Dec 2015

First posted10 Jun 2014 (estimated)
Study startFeb 2009
Primary completionDec 2015
Study completionDec 2015

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.
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 2
Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 205 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02159729
Sponsor's protocol ID: ATX-101-08-12
Status last verified: Jan 2020
First submitted: 6 Jun 2014
Last updated: 17 Feb 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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: 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
ClinicalTrials.gov ID: NCT02159729
Acronym / sponsor ID: ATX-101-08-12
Conditions: Submental Fat, Healthy
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 205 participants (actual)
Lead sponsor: Kythera BiopharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Feb 2009
Primary completion: Dec 2015 (actual)
Study completion: Dec 2015 (actual)
First posted: 10 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.

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

Detailed description

No study medication was administered in this study.

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboParticipants treated with placebo in previous ATX-101 studies
ATX-101 (1 mg/cm^2)	Experimental	Drug: ATX-101 (1 mg/cm^2)Participants treated with ATX-101 (1 mg/cm^2) in previous phase 2 studies
ATX-101 (2 mg/cm^2)	Experimental	Drug: ATX-101 (2 mg/cm^2)Participants treated with ATX-101 (2 mg/cm^2) in previous phase 2 studies
ATX-101 (4 mg/cm^2)	Experimental	Drug: ATX-101 (4 mg/cm^2)Participants treated with ATX-101 (4 mg/cm^2) in previous phase 2 studies

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (1 listed)

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

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
PlaceboClinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements and recording adverse events	Drug	Placebo
ATX-101 (1 mg/cm^2)Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements and recording adverse events	Drug	ATX-101 (1 mg/cm^2)
ATX-101 (2 mg/cm^2)Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements and recording adverse events	Drug	ATX-101 (2 mg/cm^2)
ATX-101 (4 mg/cm^2)Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements and recording adverse events	Drug	ATX-101 (4 mg/cm^2)

Primary outcome

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.
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.
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.
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.

Results and safety

Results posted to the registry on 17 Feb 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ATX-101 (Deoxycholic Acid) Injection	140	98
Placebo	65	44

Primary outcome: 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). Number. Unit: percentage of participants

Measure	ATX-101 (Deoxycholic Acid) Injection n = 104	Placebo n = 20
Baseline	100.0	100.0
Visit 1 (Month 3)	93.1	83.3
Visit 2 (Month 6)	94.0	68.8
Visit 3 (Month 9)	94.9	81.3
Visit 4 (Month 12)	94.0	82.4
Visit 5 (Month 18)	95.1	83.3
Visit 6 (Month 24)	89.6	75.0
Visit 7 (Month 36)	80.8	76.5

Population analysed: Analysis population included all who received study treatment from a previous study, and who were CR-SMFRS 1-Grade Responders at LTFU Baseline

Primary outcome: 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). Number. Unit: percentage of participants

Measure	ATX-101 (Deoxycholic Acid) Injection n = 41	Placebo n = 21
Baseline	100.0	100.0
Visit 1 (Month 3)	94.7	73.3
Visit 2 (Month 6)	94.1	80.0
Visit 3 (Month 9)	87.5	94.4
Visit 4 (Month 12)	85.0	94.4
Visit 5 (Month 18)	80.6	83.3
Visit 6 (Month 24)	85.7	82.4
Visit 7 (Month 36)	81.8	94.1

Population analysed: Analysis population included all who received study treatment from a previous study, and who were PR-SMFRS 1-Grade Responders at LTFU Baseline

Primary outcome: 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). Number. Unit: percentage of participants

Measure	ATX-101 (Deoxycholic Acid) Injection n = 30	Placebo n = 7
Baseline	100.0	100.0
Visit 1 (Month 3)	84.6	75.0
Visit 2 (Month 6)	82.6	83.3
Visit 3 (Month 9)	82.8	100.0
Visit 4 (Month 12)	79.3	71.4
Visit 5 (Month 18)	73.1	71.4
Visit 6 (Month 24)	73.1	83.3
Visit 7 (Month 36)	65.2	85.7

Population analysed: Analysis population included all who received study treatment from a previous study, and who were composite SMFRS 1-Grade Responders at LTFU Baseline

Primary outcome: 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). Number. Unit: percentage of participants

Measure	ATX-101 (Deoxycholic Acid) Injection n = 3	Placebo n = 1
Baseline	100.0	100.0
Visit 1 (Month 3)	0.0	0.0
Visit 2 (Month 6)	66.7	100.0
Visit 3 (Month 9)	66.7	100.0
Visit 4 (Month 12)	100.0	100.0
Visit 5 (Month 18)	0.0	100.0
Visit 6 (Month 24)	100.0	100.0
Visit 7 (Month 36)	100.0	0.0

Population analysed: Analysis population included all who received study treatment from a previous study, and who were composite SMFRS 2-Grade Responders at LTFU Baseline

Adverse events

Time frame: Up to 60 months from the last visit in the previous study. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ATX-101 (Deoxycholic Acid) Injection	3 of 140 (2.1%)	0 of 140 (0%)	0 of 140
Placebo	3 of 65 (4.6%)	0 of 65 (0%)	1 of 65

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.

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

20 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ATX-101 (1 mg/cm^2), ATX-101 (2 mg/cm^2) and ATX-101 (4 mg/cm^2) in people with Submental Fat and Healthy, run by Kythera Biopharmaceuticals at 20 sites in 4 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 20 sites in United States, Australia, Canada, United Kingdom. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 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 study lists 4 primary outcomes in all. 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 NCT02159729.

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; AzTrials last refreshed its copy on 6 Nov 2026.