Deoxycholic Acid Injection Submental Fat (SMF) Magnetic Resonance Imaging (MRI) and Subject-reported Outcome Measures Study

Study Overview
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Brief Summary
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Evaluation of the safety, tolerability and efficacy of deoxycholic acid injection in the reduction of submental fat (fat below the chin).

Official Title
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Multicenter, Randomized, Double-blind, Placebo-controlled Study of ATX-101 (Sodium Deoxycholate Injection) Versus Placebo for the Reduction of Localized Subcutaneous Fat in the Submental Area (SMF) Using Magnetic Resonance Imaging (MRI) and a Battery of Clinician- and Subject-reported Measurements.

Conditions
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Moderate or Severe Submental Fullness

Intervention / Treatment
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* Drug: Deoxycholic acid injection
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Moderate or severe submental fat Dissatisfaction with submental area History of stable body weight Signed informed consent Exclusion Criteria: Any medical or other condition that would affect subject safety or evaluation of efficacy Previous intervention in the submental area

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments. | Drug: Placebo<br>* Phosphate buffered saline placebo for injection<br>|
| Experimental: Deoxycholic acid Injection 1 mg/cm²<br>Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments. | Drug: Deoxycholic acid injection<br> <br> * Other names: Kybella;|
| Experimental: Deoxycholic acid Injection 2 mg/cm²<br>Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments. | Drug: Deoxycholic acid injection<br> <br> * Other names: Kybella;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Clinician-Reported Submental Fat Rating Scale Scores | The CR-SMFRS score is based on the investigator's clinical evaluation of the participant, where submental fullness is scored on a 5-point ordinal scale (0-4) with 0 = absent, 1 = mild, 2 = moderate, 3 = severe, and 4 = extreme. A negative change from Baseline indicates improvement. | Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment) | 
| Change From Baseline in Patient-Reported Submental Fat Scale Rating Scale (PR-SMFRS) | The PR-SMFRS is based on the participant's response to the question How much fat do you have under your chin right now? answered on a 5-point ordinal scale (0-4) with 0 = no chin fat at all, 1 = a slight amount of chin fat, 2 = a moderate amount of chin fat, 3 = a large amount of chin fat, and 4 = a very large amount of chin fat. A negative change from Baseline indicates improvement. | Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment) | 
| Change From Baseline in Patient-Reported Submental Fat Impact Scale (PR-SMFIS) | The PR-SMFIS assesses the impact of submental fat on self-perception of 6 emotional and visual characteristics related to the appearance of submental fullness (unhappy, bothered, self-conscious, embarrassed, look older, and look overweight) as evaluated by the participant. Each item is rated on an 11-point numeric scale from 0 to 10. Scores for the 6 items were averaged to generate a PR-SMFIS total scale score ranging from 0 to 10 where 0 is a positive outcome and 10 is a negative outcome. A negative change from Baseline indicates improvement. | Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Submental Fat Volume | Submental fat volume was measured by magnetic resonance imaging (MRI). | Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment) | 
| Change From Baseline in Submental Fat Thickness | Submental fat thickness was measured by magnetic resonance imaging (MRI). | Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment) |