Evaluation of Safety and Efficacy of Deoxycholic Acid Injection (ATX-101) in the Reduction of Submental Fat
Condition: Moderate or Severe Submental Fullness
Intervention: Deoxycholic acid injection; Placebo
Intervention description: Phosphate buffered saline placebo for injection
Intervention MeSH terms: Deoxycholic Acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 363.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To evaluate the safety and efficacy of deoxycholic acid injection in the reduction of
      submental fat (fat below the chin).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Submental fat graded by the investigator as 2 or 3 using the Clinician-Reported
             Submental Fat Rating Scale (CR-SMFRS) as determined on Visit 2.

          2. Dissatisfaction with the submental area rated by the subject as 0, 1, 2, or 3 using
             the Subject Self Rating Scale (SSRS).

          3. Males and nonpregnant, nonlactating females between 18 and 65 years of age, inclusive
             on the day of randomization. Females of childbearing potential must have a negative
             human chorionic gonadotropin (hCG) test result within 28 days before randomization and
             agree to practice medically acceptable birth control during the course of the study.
             Medically acceptable birth control includes: surgical sterilization, hormonal
             contraceptives, barrier methods or an intrauterine device (IUD).

          4. History of stable body weight, in the judgment of the investigator, for at least 6
             months before randomization. No significant change, in the judgment of the
             investigator, in diet or exercise practices for at least 6 months before randomization
             and agreement to not change diet or exercise practices during the course of the study.

          5. Expected to comply with and understand the visit schedule and all protocol-specified
             tests and procedures.

          6. Medically able to undergo the administration of study material determined by clinical
             evaluations made within 56 days before and laboratory tests obtained within 28 days
             before randomization for which the investigator identified no clinically significant
             abnormality.

          7. Signed informed consent obtained before any study-specific procedure is performed.

        Exclusion Criteria:

          1. History of any intervention to treat submental fat (e.g., liposuction, surgery, or
             lipolytic agents) or trauma associated with the chin or neck areas, which in the
             judgment of the investigator may affect evaluation of safety or efficacy of treatment.

          2. Loose skin in the neck or chin area for which reduction in submental fat may, in the
             judgment of the investigator, result in an aesthetically unacceptable outcome or a
             score of 4 on the Skin Laxity Rating Scale (SLRS).

          3. Prominent platysmal bands at rest or other anatomical features that, in the judgment
             of the investigator, may interfere with the evaluation of submental fat or result in
             an aesthetically unacceptable outcome.

          4. Evidence of any cause of enlargement in the submental area (e.g., thyroid enlargement
             or cervical adenopathy) other than localized submental fat.

          5. Body mass index (BMI) greater than 30.

          6. Currently on or considering starting a weight reduction regimen.

          7. Any medical condition (e.g., respiratory, cardiovascular, hepatic, neurological
             disease, uncontrolled hypertension, or thyroid dysfunction) that would interfere with
             assessment of safety or efficacy or compromise the subject's ability to undergo study
             procedures or provide informed consent.

          8. Treatment with radio frequency, laser procedures, chemical peels, or dermal fillers in
             the neck or chin area within 12 months before randomization, or botulinum toxin
             injections in the neck or chin area within 6 months before randomization.

          9. History of sensitivity to any components of the study material or to topical or local
             anesthetics (e.g., lidocaine, benzocaine, or novocaine).

         10. Previous randomization into this study or previous treatment with ATX-101.

         11. Treatment with an investigational device or agent within 30 days of randomization.