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

• Deoxycholic acid injection (Drug), also known as ATX-101, Kybella
• Placebo (Drug): Phosphate buffered saline placebo for injection

Primary outcomes

• Change From Baseline in Clinician-Reported Submental Fat Rating Scale Scores [Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)]: 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.
• Change From Baseline in Patient-Reported Submental Fat Scale Rating Scale (PR-SMFRS) [Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)]: 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.
• Change From Baseline in Patient-Reported Submental Fat Impact Scale (PR-SMFIS) [Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)]: 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.

Secondary outcomes

• Change From Baseline in Submental Fat Volume [Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)]: Submental fat volume was measured by magnetic resonance imaging (MRI).
• Change From Baseline in Submental Fat Thickness [Baseline and 12 weeks after last treatment (up to 32 weeks after first treatment)]: Submental fat thickness was measured by magnetic resonance imaging (MRI).

Sex: All, ages: 18 Years to 65 Years, accepts healthy volunteers

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

Participant flow

Outcome results

• Change From Baseline in Clinician-Reported Submental Fat Rating Scale Scores (Primary), Least squares mean, units on a scale: Deoxycholic Acid Injection 1 mg/cm² -0.7 (-0.90 to -0.45); Deoxycholic Acid Injection 2 mg/cm² -0.8 (-1.06 to -0.62); Placebo -0.4 (-0.58 to -0.16) (p 0.052)
• Change From Baseline in Patient-Reported Submental Fat Scale Rating Scale (PR-SMFRS) (Primary), Least squares mean, units on a scale: Deoxycholic Acid Injection 1 mg/cm² -0.9 (-1.17 to -0.72); Deoxycholic Acid Injection 2 mg/cm² -1.3 (-1.53 to -1.09); Placebo -0.7 (-0.91 to -0.49) (p 0.117)
• Change From Baseline in Patient-Reported Submental Fat Impact Scale (PR-SMFIS) (Primary), Least squares mean, units on a scale: Deoxycholic Acid Injection 1 mg/cm² -3.5 (-4.21 to -2.78); Deoxycholic Acid Injection 2 mg/cm² -4.5 (-5.25 to -3.81); Placebo -2.1 (-2.73 to -1.37) (p 0.005)
• Change From Baseline in Submental Fat Volume (Secondary), Least squares mean, mm³: Deoxycholic Acid Injection 1 mg/cm² -614 (-1093 to -136); Deoxycholic Acid Injection 2 mg/cm² -118 (-644 to 407); Placebo -8.1 (-742 to 725.7) (p 0.166)
• Change From Baseline in Submental Fat Thickness (Secondary), Least squares mean, mm: Deoxycholic Acid Injection 1 mg/cm² -1.8 (-2.37 to -1.19); Deoxycholic Acid Injection 2 mg/cm² -1.9 (-2.51 to -1.35); Placebo -0.3 (-0.83 to 0.29) (p <0.001)

Adverse events

Time frame: From the first dose of study drug until 12 weeks after the last dose (up to 32 weeks after first treatment).

Serious adverse events by term

Other adverse events by term

• Frederick Beddingfield, MD, PhD, Study director, Kythera Biopharmaceuticals, Inc.