Subcutaneous fat in the submental area MedDRA version: 14.0 Level: PT Classification code 10016251 Term: Fat tissue increased System Organ Class: 10018065 - General disorders and administration site conditions
Conditions
Sponsors
Kythera Biopharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion 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. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 360 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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, see protocol Appendix C2). 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 (see protocol Appendix B1). 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Efficacy: - To evaluate the effects of 5 mg/mL ATX-101 and 10 mg/mL ATX-101 transcutaneous injections in the submental area, relative to placebo, for the reduction of fat - To evaluate the effects of 5 mg/mL ATX-101 and 10 mg/mL ATX-101 transcutaneous injections in the submental area, relative to placebo, for subject satisfaction Safety: - To evaluate the safety of transcutaneous injections of ATX-101 in the submental area, relative to placebo, as assessed by spontaneous adverse event reports, clinical evaluation of the submental area, and laboratory test results;Secondary Objective: To evaluate the effects of 5 mg/mL ATX-101 and 10 mg/mL ATX-101 transcutaneous injections in the submental area, relative to placebo, based on subject-reported outcome measures and an objective measure of submental fat thickness using calipers.;Primary end point(s): Efficacy: - Percentage of subjects who are responders with respect to the CR-SMFRS scores, defined as a 1-point improvement from baseline at Visit 7 (12 weeks after last treatment) -Percentage of subjects who are responders with respect to the subject self rating scale, expressing satisfaction (SSRS score of 4 or higher) with their appearance at Visit 7 (12 weeks after last treatment) Safety endpoints include: - Incidence, severity, and duration of all treatment-emergent adverse events - Incidence of study material-related adverse events - Severity and duration of study material-related adverse events - Changes from baseline in clinical laboratory test results - Changes from baseline in vital sign and weight measurements;Timepoint(s) of evaluation of this end point: 12 weeks after the last treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Percentage of subjects who are responders with respect to the change in SMF, having at least a 2-point improvement relative to baseline in CR-SMFRS score at Visit 7 - Change from baseline in CR-SMFRS scores at Visit 7 (data treated as a continuous variable) - Change from baseline in SSRS scores at Visit 7 (data treated as a continuous variable) - Caliper measurements of the submental area Subject-reported outcome measures;Timepoint(s) of evaluation of this end point: 12 weeks after the last treatment | — |
Countries
Belgium, Germany, Italy, Spain, United Kingdom
Contacts
Public ContactKythera Clinical Group
Kythera Biopharmaceuticals, Inc.
Outcome results
None listed