Moderate to Severe Convexity of Submental FatPhase 3NCT02035267

Safety Study of ATX-101 (Deoxycholic Acid) in Subjects With Mild or Extreme Fullness of Submental Fat

A Phase 3 study testing Deoxycholic Acid in people with Moderate to Severe Convexity of Submental Fat and Safety, run by Kythera Biopharmaceuticals at 8 sites in United States.

Completed

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

Official record

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Trial summary

The objectives of this study are to explore the safety and efficacy of subcutaneous injections of Deoxycholic Acid relative to placebo, in the submental area in patients with mild or extreme fullness of the submental fat and ratings of 1 or 4. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Moderate to Severe Convexity of Submental Fat, Safety, Efficacy
What is being tested?: Deoxycholic Acid
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 93 participants
Where: 8 sitesUnited States
Study dates: Jan 2014to Jun 2015
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

Male and female subjects, 18 to 65 years old
Stable Body weight
Body Mass Index (BMI) of ≤40.0 kg/m^2
Acceptable volume of submental fat graded by clinician
Dissatisfaction with the submental area expressed by the subject
Signed informed consent form (ICF)
SMF ratings of 1 or 4

Who cannot join

No prior intervention for submental fat (SMF) (eg, liposuction, surgery, or lipolytic agents)
Presence of clinically significant health problems
History of trauma associated with the chin or neck areas that in the judgment of the investigator may affect evaluation of safety or efficacy of treatment
Body mass index ≤40 kg/m^2

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

Study site
Boca Raton, Florida
Study site
Chestnut Hill, Massachusetts, 02467
Study site
Coral Gables, Florida, 33146
Study site
Glenn Dale, Maryland, 20769
Study site
Newport Beach, California
Study site
San Francisco, California
Study site
St Louis, Missouri
Study site
West Hollywood, California, 90069

Other trials in United States

About this study

Official title: A Multicenter, Double-blind, Placebo-controlled Safety Study of ATX-101 (Deoxycholic Acid) Injection for the Reduction of Localized Subcutaneous Fat in the Submental Area in Subjects With Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) Grade 1 or CR-SMFRS Grade 4

Conditions: Moderate to Severe Convexity of Submental Fat, Safety, Efficacy
Being tested: Deoxycholic Acid, Placebo

What participants receive

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

Deoxycholic AcidDrug
Also called ATX-101 deoxycholic acid injection
Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL.
PlaceboDrug
Phosphate buffered saline placebo for injection.

Study groups in NCT02035267
Study group	Role	What they receive
Placebo - Grade 1	Placebo comparator	Participants received placebo administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments. Participants With CR SMFRS Grade 1 (mild). Receives: Drug: Placebo
ATX-101 deoxycholic acid injection - Grade 1	Experimental	Participants received deoxycholic acid 2 mg/cm^2 administered in 0.2 mL SC injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments. Participants With Clinician-Reported Submental Fat Rating Scale (CR SMFRS) Grade 1 (mild). Receives: Drug: Deoxycholic Acid
Placebo - Grade 4	Placebo comparator	Participants received placebo administered in 0.2 mL SC injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments. Participants With CR SMFRS Grade 4 (extreme). Receives: Drug: Placebo
ATX-101 deoxycholic acid injection - Grade 4	Experimental	Participants received deoxycholic acid 2 mg/cm^2 administered in 0.2 mL SC injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments. Participants with CR SMFRS Grade 4 (extreme). Receives: Drug: Deoxycholic Acid

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With at Least a 1-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on Both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) Assessments
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).
Measured: Baseline and up to Week 32 (12 weeks after last treatment)
Percentage of Participants With at Least a 2-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on Both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) Assessments
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).
Measured: Baseline and up to Week 32 (12 weeks after last treatment)
Percentage of Participants With at Least a 1-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)
The investigator evaluated the participant's chin and neck area using the CR-SMFRS 5-point scale where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst).
Measured: Baseline and up to Week 32 (12 weeks after last treatment)
Percentage of Participants With at Least a 2-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)
The investigator evaluated the participant's chin and neck area using the CR-SMFRS 5-point scale where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst).
Measured: Baseline and up to Week 32 (12 weeks after last treatment)
Percentage of Participants With at Least a 1-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on Patient-Reported Submental Fat Rating Scale (PR-SMFRS)
The participant evaluated their chin and neck area using the PR-SMFRS 5-point scale where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst).
Measured: Baseline and up to Week 32 (12 weeks after last treatment)
Percentage of Participants With at Least a 2-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on Patient-Reported Submental Fat Rating Scale (PR-SMFRS)
The participant evaluated their chin and neck area using the PR-SMFRS 5-point scale where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst).
Measured: Baseline and up to Week 32 (12 weeks after last treatment)
Change From Baseline in Submental Skin Laxity Grade Scale (SMSLG)
The SMSLG is an integration of three features: skin wrinkling, adherence to underlying neck structures (bone and muscle) and redundancy (horizontal and vertical folds). Each grade (1=none, 2=mild, 3=moderate and 4=severe) defines the maximal allowed limit for skin wrinkling, adherence to underlying structures and redundancy.
Measured: Baseline and up to Week 32 (12 weeks after last treatment)

Timeline

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

Jan 2014Jun 2015

First posted14 Jan 2014 (estimated)
Study startJan 2014
Primary completionJun 2015
Study completionJun 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 Moderate to Severe Convexity of 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 93 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02035267
Sponsor's protocol ID: ATX-101-13-27
Status last verified: Jan 2020
First submitted: 12 Jan 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: A Multicenter, Double-blind, Placebo-controlled Safety Study of ATX-101 (Deoxycholic Acid) Injection for the Reduction of Localized Subcutaneous Fat in the Submental Area in Subjects With Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) Grade 1 or CR-SMFRS Grade 4
ClinicalTrials.gov ID: NCT02035267
Acronym / sponsor ID: ATX-101-13-27
Conditions: Moderate to Severe Convexity of Submental Fat, Safety, Efficacy
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 93 participants (actual)
Lead sponsor: Kythera BiopharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Jan 2014
Primary completion: Jun 2015 (actual)
Study completion: Jun 2015 (actual)
First posted: 14 Jan 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Placebo - Grade 1	Placebo comparator	Drug: PlaceboParticipants received placebo administered in 0.2 mL subcutaneous (SC) injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments. Participants With CR SMFRS Grade 1 (mild).
ATX-101 deoxycholic acid injection - Grade 1	Experimental	Drug: Deoxycholic AcidParticipants received deoxycholic acid 2 mg/cm^2 administered in 0.2 mL SC injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments. Participants With Clinician-Reported Submental Fat Rating Scale (CR SMFRS) Grade 1 (mild).
Placebo - Grade 4	Placebo comparator	Drug: PlaceboParticipants received placebo administered in 0.2 mL SC injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments. Participants With CR SMFRS Grade 4 (extreme).
ATX-101 deoxycholic acid injection - Grade 4	Experimental	Drug: Deoxycholic AcidParticipants received deoxycholic acid 2 mg/cm^2 administered in 0.2 mL SC injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments. Participants with CR SMFRS Grade 4 (extreme).

Who may qualify

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

Key inclusion criteria (7 listed)

Male and female subjects, 18 to 65 years old
Stable Body weight
Body Mass Index (BMI) of ≤40.0 kg/m^2
Acceptable volume of submental fat graded by clinician
Dissatisfaction with the submental area expressed by the subject

Key exclusion criteria (4 listed)

No prior intervention for submental fat (SMF) (eg, liposuction, surgery, or lipolytic agents)
Presence of clinically significant health problems
History of trauma associated with the chin or neck areas that in the judgment of the investigator may affect evaluation of safety or efficacy of treatment
Body mass index ≤40 kg/m^2

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
Deoxycholic AcidAlso: ATX-101 deoxycholic acid injectionFormulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL.	Drug	ATX-101 deoxycholic acid injection - Grade 1, ATX-101 deoxycholic acid injection - Grade 4
PlaceboPhosphate buffered saline placebo for injection.	Drug	Placebo - Grade 1, Placebo - Grade 4

Primary outcome

Percentage of Participants With at Least a 1-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on Both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) Assessments
Time frame: Baseline and up to Week 32 (12 weeks 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).
Percentage of Participants With at Least a 2-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on Both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) Assessments
Time frame: Baseline and up to Week 32 (12 weeks 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).
Percentage of Participants With at Least a 1-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)
Time frame: Baseline and up to Week 32 (12 weeks after last treatment)
The investigator evaluated the participant's chin and neck area using the CR-SMFRS 5-point scale where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst).
Percentage of Participants With at Least a 2-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)
Time frame: Baseline and up to Week 32 (12 weeks after last treatment)
The investigator evaluated the participant's chin and neck area using the CR-SMFRS 5-point scale where: 0=absent submental convexity (best) to 4= extreme submental convexity (worst).
Percentage of Participants With at Least a 1-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on Patient-Reported Submental Fat Rating Scale (PR-SMFRS)
Time frame: Baseline and up to Week 32 (12 weeks after last treatment)
The participant evaluated their chin and neck area using the PR-SMFRS 5-point scale where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst).
Percentage of Participants With at Least a 2-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on Patient-Reported Submental Fat Rating Scale (PR-SMFRS)
Time frame: Baseline and up to Week 32 (12 weeks after last treatment)
The participant evaluated their chin and neck area using the PR-SMFRS 5-point scale where: 0=no chin fat at all (best) to 4= a very large amount of chin fat (worst).
Change From Baseline in Submental Skin Laxity Grade Scale (SMSLG)
Time frame: Baseline and up to Week 32 (12 weeks after last treatment)
The SMSLG is an integration of three features: skin wrinkling, adherence to underlying neck structures (bone and muscle) and redundancy (horizontal and vertical folds). Each grade (1=none, 2=mild, 3=moderate and 4=severe) defines the maximal allowed limit for skin wrinkling, adherence to underlying structures and redundancy.

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 - Grade 1	31	31
Placebo Injection - Grade 1	16	15
ATX-101 (Deoxycholic Acid) Injection - Grade 4	30	28
Placebo Injection - Grade 4	16	15

Primary outcome: Percentage of Participants With at Least a 1-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on Both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) Assessments

Time frame: Baseline and up to Week 32 (12 weeks after last treatment). Number. Unit: percentage of participants

Measure	ATX-101 (Deoxycholic Acid) Injection - Grade 1 n = 31	Placebo Injection - Grade 1 n = 15	ATX-101 (Deoxycholic Acid) Injection - Grade 4 n = 28	Placebo Injection - Grade 4 n = 15
Value	61.3	6.7	89.3	13.3

Population analysed: Intent to treat (ITT) population included all randomized participants, whether or not they received the assigned study drug.

Primary outcome: Percentage of Participants With at Least a 2-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on Both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) Assessments

Time frame: Baseline and up to Week 32 (12 weeks after last treatment). Number. Unit: percentage of participants

Measure	ATX-101 (Deoxycholic Acid) Injection - Grade 4 n = 28	Placebo Injection - Grade 4 n = 15
Value	42.9	0

Population analysed: Intent to treat (ITT) population included all randomized participants, whether or not they received the assigned study drug. Only subjects with baseline CR-SMFRS grade 4 were included, since a 2-grade improvement was not possible for subjects with baseline CR-SMFRS grade 1.

Primary outcome: Percentage of Participants With at Least a 1-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)

Time frame: Baseline and up to Week 32 (12 weeks after last treatment). Number. Unit: percentage of participants

Measure	ATX-101 (Deoxycholic Acid) Injection - Grade 1 n = 31	Placebo Injection - Grade 1 n = 15	ATX-101 (Deoxycholic Acid) Injection - Grade 4 n = 28	Placebo Injection - Grade 4 n = 15
Value	74.2	20.0	96.4	26.7

Population analysed: Intent to treat (ITT) population included all randomized participants, whether or not they received the assigned study drug.

Primary outcome: Percentage of Participants With at Least a 2-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS)

Time frame: Baseline and up to Week 32 (12 weeks after last treatment). Number. Unit: percentage of participants

Measure	ATX-101 (Deoxycholic Acid) Injection - Grade 4 n = 28	Placebo Injection - Grade 4 n = 15
Value	71.4	13.3

Adverse events

Time frame: Up to 32 Weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ATX-101 (Deoxycholic Acid) Injection - Grade 1	1 of 31 (3.2%)	30 of 31 (96.8%)	0 of 31
Placebo Injection - Grade 1	0 of 16 (0%)	15 of 16 (93.8%)	0 of 16
ATX-101 (Deoxycholic Acid) Injection - Grade 4	1 of 30 (3.3%)	29 of 30 (96.7%)	0 of 30
Placebo Injection - Grade 4	0 of 16 (0%)	13 of 16 (81.3%)	0 of 16

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

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Deoxycholic Acid in people with Moderate to Severe Convexity of Submental Fat and Safety, run by Kythera Biopharmaceuticals at 8 sites in United States.

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 7 inclusion and 4 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 8 sites in United States. 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 With at Least a 1-Grade Reduction (Improvement) at 12 Weeks From Last Treatment Based on Both the Clinician-Reported Submental Fat Rating Scale (CR-SMFRS) and Patient-Reported Submental Fat Rating Scale (PR-SMFRS) Assessments (time frame: Baseline and up to Week 32 (12 weeks after last treatment)). The study lists 7 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 NCT02035267.

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 7 Nov 2026.