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

Phase 3CompletedNCT02035267

Kythera Biopharmaceuticals93 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Moderate to Severe Convexity of Submental Fat Safety Efficacy

Interventions

Deoxycholic AcidDRUG

Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL.

PlaceboDRUG

Phosphate buffered saline placebo for injection.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (8)

Unnamed facility

Newport Beach, California, United States

Unnamed facility

San Francisco, California, United States

Unnamed facility

West Hollywood, California, United States

Unnamed facility

Boca Raton, Florida, United States

Outcomes

Primary Outcomes

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).

Time frame: 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

Time frame: 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).

Time frame: 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).

Data from ClinicalTrials.gov

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