Reduction of subcutaneous fat in the submental area
Conditions
Interventions
Product Name: ATX-101
Pharmaceutical Form: Solution for injection
CAS Number: 83-44-3
Current Sponsor code: ATX-101
Other descriptive na
Sponsors
Kythera Biopharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Submental fat that is considered undesirable by the participant and graded by the Investigator as 2 or 3 using the SMF Rating Scale (Appendix C of the protocol). - Males or nonpregnant, nonlactating females who are aged 25 to 65 years, inclusive, on the date of randomization. Females of childbearing potential must have a negative human chorionic gonadotropin (HCG) test result within 28 days before randomization and must agree to practice adequate contraception, in the judgment of the investigator, during the course of the trial. - History of maintenance of a stable body weight, in the judgement of the Investigator, for at least 6 months before randomization. - The subject is expected to comply with and understand the visit schedule and all of the protocol-specified tests and procedures. - The subject is medically able to undergo the administration of study material as determined by clinical and laboratory evaluations (section 7.2 of the protocol) obtained within 28 days before randomization, for which the investigator identifies no clinically significant abnormality. - Signed informed consent obtained before any study specific procedure is conducted. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - History of any intervention to treat submental fat (e.g. liposuction) or trauma associated with the chin or neck areas, which in the judgment of the investigator, may affect safety or efficacy evaluation of the treatment. - Loose skin in the neck or chin area for which reduction in submental fat may, in the judgement of the Investigator, result in a cosmetically unacceptable outcome. - Prominent platysmal bands at rest that interfere with the evaluation of submental fat. - Evidence of any cause of enlargement in the submental area (eg. thyroid enlargement, cervical adenopathy) other than localised submental fat. - Fitzpatrick Skin Type IV, V, or VI (Appendix B of the protocol). - Currently on, or considering starting, a weight reduction regimen. - Any medical condition (e.g. respiratory, cardiovascular, hepatic, neurological disease, uncontrolled hypertension, thyroid dysfunction), that would interefere with the assessment of safety or efficacy in this trial or would compromise the ability of the subject to undergo study procedures or to give informed consent. - Treatment with fish oil or nonsteroidal anti-inflammatory agents (NSAIDs) within seven days before randomisation, or any anticipated need for agents with anticoagulative effects (e.g. warfarin, heparin) during the course of the trial. Aspirin used for prophylaxis will be allowed. - Treatment with oral anticoagulants (e.g. warfarin) within 28 days before randomisation. - Treatment with radio frequency, laser procedures, chemical peel, or dermal fillers in the neck or chin area within 12 months before randomization, or botulinum toxin injections within 6 months before randomization. - History of sensitivity to any components of the study material or to topical or local anaesthetics (e.g. lidocaine, benzocaine, novocaine). - Previous randomization into this trial. - Treatment with an investigational device or agent within 30 days before randomization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the safety and tolerability of ATX-101 injections at three concentrations, relative to placebo.;Secondary Objective: To evaluate the potential efficacy of ATX-101, relative to placebo, in reducing subcutaneous fat in the submental area.; Primary end point(s): 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 and urinalysis test results - changes from baseline in vital sign and weight measurements | — |
Countries
United Kingdom
Outcome results
None listed