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

Study Overview
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Brief Summary
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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.

Official Title
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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
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Moderate to Severe Convexity of Submental Fat, Safety, Efficacy

Intervention / Treatment
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* Drug: Deoxycholic Acid
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

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 - Grade 1<br>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). | Drug: Placebo<br>* Phosphate buffered saline placebo for injection.<br>|
| Experimental: ATX-101 deoxycholic acid injection - Grade 1<br>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). | Drug: Deoxycholic Acid<br>* Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL.<br>* Other names: ATX-101 deoxycholic acid injection;|
| Placebo Comparator: Placebo - Grade 4<br>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). | Drug: Placebo<br>* Phosphate buffered saline placebo for injection.<br>|
| Experimental: ATX-101 deoxycholic acid injection - Grade 4<br>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). | Drug: Deoxycholic Acid<br>* Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL.<br>* Other names: ATX-101 deoxycholic acid injection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | 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). | 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). | 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). | 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). | 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. | Baseline and up to Week 32 (12 weeks after last treatment) |